June-2011

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R&C/AJ/PDS/1978

ISSUE 68

PHARMA C HRONICLE
Since 2009

June 2011

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CONTENTS
INSIDE THIS ISSUE:
CHRONICLE SPOTLIGHT NEWS FROM THE GULF INSIGHTS: The World’s Biggest R&D Spenders P RODUCT LAUNCH F EATURE: AstraZeneca Pulls Plug On Free Trips For Doctors DRUG MARKET: A Snapshot Of Cholesterol Drug Market NEWS UPDATE F DA APPROVALS E MA NEWS F UNNY PHARMA CARTOON AREEGMENTS & COLLABORATIONS P HARMA ARTICLES

JUNE 2011

5—12 13 14 16 17 18 19— 19—23 24— 24—26 27 28 29 30— 30—38 39— 39—40 41 42 43— 43—46

eyeforpharma ARTICLES
UPCOMING EVENT IN VIENNA, AUSTRIA UPCOMING CONFERENCE IN LONDON, UNITED KINGDOM

eyeforpharma ARTICLES

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CHRONICLE SPOTLIGHT
GERMANY SUSPENDS TOP TAKEDA DIABETES DRUG ACTOS
Moves follow study showing slightly raised cancer risk.
Germany has joined France in suspending the use of Takeda Pharmaceutical's Actos diabetes drug, due to worries about a possible link to cancer.

JUNE 2011

The move is a blow for the Japanese firm, whose best-selling drug has worldwide sales of close to $5 billion, though the financial impact will be limited by the fact the drug faces looming generic competition in key markets. Shares in Takeda fell 2.9 percent on Jun. 10, 2011, against a
0.5 percent rise in the benchmark Nikkei average.

On Jun. 9, 2011, France's drug safety authority suspended use of both Actos and Competact -which combines Actos and an older drug called metformin -- after an official French study found they appeared to slightly raise the risk of bladder cancer. Germany's Federal Institute for Drugs and Medical Devices (BfArM) said it had decided to follow suit after receiving results of the study by France's national health insurance body, which tracked patients on diabetes drugs between 2006 and 2009. “BfArM recommends the suspension of approval of pioglitazone (Actos) until further clarification. Doctors should not put new patients on pioglitazone,” the German regulator said in a statement. A Takeda spokesman had earlier said the German authorities had informed the company of their intentions. Both the French and German regulators said patients currently being prescribed Actos should continue to take their medicines until they could consult with their doctors, since they could be in danger if they stopped treatment. Other European countries are holding fire on Actos and a spokeswoman for the European Medicines Agency said it was not aware of any other national authorities taking action. The European agency, based in London, initiated a review into the safety of Actos in March and its experts will discuss the latest data on the drug at a June 20-23 meeting. Britain's drugs regulator said it was not recommending any changes to Actos use while the European review was going on and the Danish medicines agency also told Reuters it had no plans to “go it alone” on suspending the drug.

NO ACTION FROM FDA
In the United States, the FDA initiated a safety review of Actos last September, but Takeda said U.S. regulators had not signaled any intention to request a recall.

Japan's health ministry also said the body had no plans for a recall of the blockbuster product, which had global sales of 387.9 billion yen ($4.8 billion) in the year ended on March 31, accounting for 27 percent of Takeda's revenues.
Actos belongs to the same drug class as GlaxoSmithKline's Avandia, which was pulled

from the market in Europe and had severe restrictions imposed on its use in the United States last September, after being linked to heart risks.
GSK's drug has not been associated with bladder cancer. Actos was approved for use in Europe in 2000 but its potential bladder cancer risk, seen in tests of male rats, has long been a topic of discussion. Interim results from trials being conducted by U.S. health insurer Kaiser Permanente, one of which began in 2003 and is slated to last 10 years, have so far not confirmed a clear association between Actos and bladder cancer. (Source: http://www.chicagotribune.com/business/breaking/chi-germany-suspends-toptakeda-diabetes-drug-actos-20110610,0,5901033.story │“Germany suspends top Takeda diabetes drug Actos” by James Topham and Ben Hirschler│Reuters – Jun. 8, 2011)

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CHRONICLE SPOTLIGHT
li Lilly & Co. won a ruling in a lawsuit brought by Amylin Pharmaceuticals Inc., which wants to prevent Lilly from using the same people to sell Amylin’s diabetes drug and that of a competitor.

JUNE 2011

L ILLY WINS RULING IN DIS PUT E WIT H AMYLIN GROUP OF BP DRUGS NOT LINKED TO CANCER
E D espite concerns that blood pressure drugs may increase the risk
of cancer, a new study suggests that a particular such drug may not be linked to that risk. Angiotensin-converting enzyme inhibitors, usually referred to as ACE inhibitors, are not associated with a higher rate of cancer,

A federal judge in San Diego denied Amylin’s request for a preliminary order that would have imposed restrictions on Lilly’s diabetes sales force, the Indianapolis-based drugmaker said in a statement today. “We are pleased with the court’s decision,” Robert A. Armitage, Lilly’s general counsel, said in the statement. “We believe that Amylin’s allegations against Lilly are entirely without merit and we fully expect to prevail in this litigation.”
Amylin, based in San Diego, sued Lilly last month, saying the manner in which Lilly plans to implement an agreement to develop and sell Boehringer Ingelheim GmbH’s type 2 diabetes drug breached its agreement to develop and commercialize Amylin’s competing drugs. Amylin said in a statement today it will pursue the litigation.

according to a study by researchers at University Hospitals Case Medical Center in Cleveland. "There were worries in the scientific community that ACE inhibitors were associated with cancer," study co-author Dr. Ilke Sipahi told Reuters Health. The study results, he added, "confirm the safety of ACE inhibitors as far as cancer goes."
ACE inhibitors lower blood pressure by blocking the production of

“Amylin continues to believe that Lilly’s conduct violates our diabetes collaboration agreements, is anti-competitive and limits patients’ treatment options,” the company said. “It is important to note that the court’s decision did not make any findings on the merits of our claims, but merely declines to award injunctive relief, based on the conclusion that monetary damages would be sufficient.” The lawsuit is filed under seal and court documents weren’t immediately available.
(Source: http://www.bloomberg.com/news/2011-06-08/lilly-wins-ruling-in-disputewith-amylin-over-marketing-of-diabetes-drugs.html │“Lilly Wins Ruling in Dispute With Amylin Over Marketing of Diabetes Drugs” by Edvard Pettersson │Bloomberg News – Jun. 9, 2011)

a chemical that causes blood vessels to contract. In addition to controlling blood pressure, they are used to improve survival after heart attacks, and prevent strokes. Before this study, there was a mixed picture about whether ACE inhibitors were linked to cancer. A previous study by Sipahi's group, for example, found that a similar group of drugs, known as angiotensin receptor blockers, was associated with an increased likelihood of cancer. In the new study, published in The American Journal of Cardiology, the researchers reviewed existing trials of ACE inhibitors that measured how many patients developed or died of cancer. One of those previous studies linked ACE inhibitors to an increased risk of digestive system cancers, but the authors did not find any association in this review. Sipahi did caution that the reviewed studies followed patients for a maximum of 5 years, so the team could not determine the effect of ACE inhibitors on the risk of developing cancer over a period longer than 5 years. Still, the limitations of the data mean that more research is needed, Dr. Christopher Phillips, of Morehouse School of Medicine in Atlanta, Georgia, told Reuters Health. Phillips, who was not involved in the study, noted that the authors only dove deeply into data for one type of ACE inhibitors, enalapril, marketed as Vasotec. The study showed that enalapril does not increase the risk of cancer, he said. But "can we attribute
that to all the ACE inhibitors or just enalapril?"

ZIOPHARM PLANS EARLY TRIALS OF NEW CANCER DRUGS
iopharm gets FDA approval to conduct human trials of a potential melanoma treatment. Ziopharm Oncology Inc. said on Jun. 10, 2011 that the Food and Drug Administration will allow it to conduct human testing of an experimental melanoma

Z

drug. The company said the FDA accepted its application for the drug. It designated the product ZIN ATI-001 and said it plans to start an early-stage clinical trial to evaluate its safety and its effects. Ziopharm said new preclinical studies indicate the new drug candidate works similarly to a DNA drug in early-stage testing. ZIN ATI-001 is being developed as part of a partnership between Ziopharm and Intrexon Corp. Ziopharm's most advanced drug candidates include treatments for myeloma, leukemia and lymphoma, and liver cancer. Those products are all in midstage testing.
(Source: http://finance.yahoo.com/news/Ziopharm-plans-early-trials-apf1188026813.html?x=0&.v=1 │“Ziopharm plans early trials of new cancer drug” │Associated Press – New York │Jun. 10, 2011)

The limitations mean that the study "should not affect the current clinical prescribing of ACE inhibitors to eligible patients who need them," Phillips said. Patients taking ACE inhibitors may experience side effects, including cough, headache, drowsiness, or weakness, and in rare cases, kidney failure or swelling of tissues. They range from $10 per month for generic drugs to more than $100 per month for brand names.
(Source: http://www.reuters.com/article/2011/06/08/us-groupblood-pressure-idUSTRE7575QT20110608 │“Group of blood pressure drugs not linked to cancer” by Eric Schultz │Reuters Health – New York │Jun. 8, 2011)

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CHRONICLE SPOTLIGHT
THE SCARY THING ABOUT THE FDA’S SIMVASTATIN DECISION

JUNE 2011

O n Jun. 7, 2011 the Food and Drug Administration told doctors to stop prescribing the top 80-milligram dose of simvastatin, also known by the
brand name Zocor, to new patients because of a heightened risk of muscle pain. This decision will affect millions of patients.

To keep perspective, the fact that other cholesterol-lowering statin drugs like Lipitor and Crestor are more potent probably factored into this decision — if the top dose of Zocor were the only option, the FDA might have kept it. Steven Nissen of the Cleveland Clinic, who said as early as 2004 that doctors should not be using the 80 mg dose, emphasized that statins are “among the safest and most important drugs in all of medicine” and that the risks outweigh the benefits for other doses of simvastatin, Lipitor, pravastatin and other drugs.
What is scary isn’t so much the case of simvastatin itself — this is an issue doctors can handle — but the fact that simvastatin was approved in

1991. This drug has been on the market for 20 years. And, despite the tone of much of the coverage, this is not a medicine only taken by a few people. The FDA said that 2.1 million people had been prescribed the 80 milligram dose, either by itself or in a combination pill like Vytorin or Simcor,
last year.

Script data from IMS Health shows that forms of simvastatin were prescribed 100 million times last year. The 80 milligram doses of simvastatin and Vytorin were prescribed 11.3 million and 1 million times, respectively. That means the 80 milligram dose of simvastatin was prescribed more times than all doses of Vytorin, which was prescribed 8.6 million times last year. Vytorin generated $1.3 billion in U.S. sales last year, according to IMS. This is like the FDA telling doctors to stop using
a blockbuster drug.

What’s really food for thought, though, is that this risk emerged after the top dose of simvastatin was studied by Merck in two very large trials, A to Z and Search, and then very quickly rose to become a super-popular medicine after it went generic. The FDA then did its own study of side effect reports sent in by doctors and patients. Most drugs get nowhere near this much scrutiny. That is why, when taking
a medicine, it is always fair to ask not just what the side effects are, but what they might be.

Remember though, that simvastatin’s benefits could still outweigh its risk were it not for the fact that the creation of a bunch of me-too drugs like Lipitor and Crestor gave patients who need high-octane cholesterol drugs even better options.
(Source: http://blogs.forbes.com/matthewherper/2011/06/09/the-scary-thing-about-the-fdas-simvastatin-decision/?partner=yahootix │“The Scary Thing About the FDA’s Simvastatin Decision” by Matthew Herper │Jun. 9, 2011)

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CHRONICLE SPOTLIGHT
REASEARCHERS’ HOPE OF 20 NEW VACCINES IN NEXT DECADE
Researchers writing in The Lancet say there is the potential to develop 20 new or improved vaccines in the next decade.

JUNE 2011

A group of scientists says funding is crucial - but so is trust and confidence in vaccines. They identify AIDS and malaria vaccines as the most important areas for research. But the authors say neglected tropical diseases, such as leprosy, should also be investigated. And in a "call to action", the scientists say, "We must also consider vaccines beyond classic infections, such as insulin-dependent diabetes, cancers and degenerative diseases.”

'Fragile' confidence
"We need to find the requisite funds for the research and development of about 20 improved or novel vaccines in the next decade or beyond. This call to action comes at a crucial time. In some communities, recent declines in vaccine uptake provide a stark reminder that public confidence and trust in immunization is fragile and requires attention." Professor Richard Moxon, from Oxford University, came up with the idea for the series of papers looking at the future of vaccine research. He said, "Considering the unambiguous and beneficial track record of immunization, it is perhaps surprising that the public aren't always comfortable with it. It's complex. Perhaps one of the things that is most important is that vaccines are given to healthy people - often children.”

Safety issues
"Safety issues loom very large because there's very little awareness of many of the diseases that have been prevented by vaccines, such as polio and whooping cough." Professor Moxon said he believed an AIDS vaccine was still many years away, but there might be an effective malaria vaccine within five years. He and his fellow authors are calling on developing countries to shoulder more of the responsibility for financing vaccination programmes. They said, "Most developing countries accord too low a priority to health in their budgets. They must be persuaded to take more of the burden themselves on behalf of their poorer citizens."
Funding for vaccines in developing countries will be examined at a crucial meeting in London on Jun. 13, 2011 when an effort is made to raise more than £2m for immunization programmes over the next four years. (Source: http://www.bbc.co.uk/news/health-13714224 │“Researchersʹ hope of 20 new vaccines in next decade” by Jane Dreaper, Health correspondent, BBC News │Jun. 9, 2011)

M ERCK, GSK DRUGS ADD WARNINGS ABOUT PROSTRATE CANCER RISK
M erck & Co. and GlaxoSmithKline Plc (GSK)’s drugs for hair loss and enlarged prostate will carry new U.S. warnings about a low risk of being
diagnosed with a more serious form of prostate cancer. The Food and Drug Administration revised the prescribing information for Merck’s Proscar and Propecia and Glaxo’s Avodart and Jalyn based on the

findings of two studies, the agency said on Jun. 9, 2011 in a statement. From 2002 to 2009 about 5 million men were prescribed one of these drugs, known as 5-ARIs, including almost 3 million men ages 50 to 79, the FDA said. In March, London-based Glaxo abandoned efforts to expand use of Avodart to prevent prostate cancer after an FDA advisory panel said neither
Avodart nor Proscar had a favorable risk- benefit ratio.

The advisers raised concerns that the drug was masking harmful tumors by lowering levels of prostate-specific antigen, a protein used to detect cancer in the blood. “FDA believes that 5-ARIs remain safe and effective for their approved indications,” the agency said.
Jalyn is a combination treatment for enlarged prostate that includes Avodart. Propecia, a drug for hair loss, contains the same active ingredient as

Proscar from Whitehouse Station, New Jersey-based Merck.
(Source: http://www.bloomberg.com/news/2011-06-09/merck-glaxo-drugs-to-carry-warnings-about-prostate-cancer-risk.html │“Merck, Glaxo Drugs Add Warnings About Prostate Cancer Risk” by Catherine Larkin │Bloomberg News – Jun. 9, 2011)

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CHRONICLE SPOTLIGHT
PILL TO MEND A BROKEN HEART ‘DEVELOPED BY SCIENTISTS’
A

JUNE 2011

pill that triggers the heart to repair itself after an attack is being developed by scientists in a major step towards one of the “desired object or outcome” of medical research.

British-based researchers claim they may be just a decade away from perfecting a way to persuade the heart to rejuvenate – a process thought to be impossible just five years ago. That means that when a heart attack occurs, the muscles and blood vessels around the organ could rebuild themselves – massively reducing long-term damage and improving the quality of life of the victim.

The researchers at University College London have discovered that a protein known as thymosin Beta 4, key to heart growth in the young, appears to reawaken dormant stem cells in the organ of adults. They now hope to begin human trials in a few years after experiments on mice showed that it improved the performance of the heart by as much as 25 per cent. Professor Paul Riley, the research leader, said, "I could envisage a patient known to be at risk of a heart attack – either because of family history or warning signs spotted by their GP – taking an oral tablet, along the lines of a statin, which would prime their heart so that if they had a heart attack, the damage could be repaired." Unlike other organs, it was thought until recently that the heart lacked the ability to heal damage to itself. That meant when someone had a heart
attack, they had to live with damage and their quality of life was often severely curtailed.

More than 750,000 people live with heart failure in the UK alone, with everyday tasks such as eating, dressing and getting out of bed, leaving many breathless and exhausted. Treatments range from drugs to transplants but with up to 40 per cent of those affected dying within a year of diagnosis, heart failure has worse survival rate than many cancers. "It looks as if heart repair is a possibility," said Professor Peter Weissberg, medical director of the British Heart Foundation, which funded the research. "Even five years ago people were saying this is science fiction this is fantasy. It is the start of a long process. A small improvement in the heart condition will be a massive improvement in quality of life of the patient." Prof Jeremy Pearson, associate medical director at the British Heart Foundation, said, "To repair a damaged heart is one of the holy grails of heart research. This groundbreaking study shows adult hearts contain cells that, given the right stimulus, can mobilize and turn into new heart cells that might repair a damaged heart." The study was published in the journal Nature.
(Source: http://www.telegraph.co.uk/health/healthnews/8563799/Pill-to-mend-a-broken-heart-developed-by-scientists.html │“Pill to mend a broken heart ʹdeveloped by scientistsʹ” by Richard Alleyne, Science Correspondent │Jun. 9, 2011)

L IL L Y S IG N S F O RT E O P R OM OT IO N

D EA L W I TH S YN T H E S

D rugmaker Eli Lilly and Co. has signed a deal with Swiss company Synthes Inc. to co-promote the bone drug Forteo and develop other potential
orthopedic treatments. Terms of the deal were not disclosed. Lilly, which is based in Indianapolis, said on Jun. 9, 2011 it will license some early stage or pre-clinical compounds to Synthes for that company to develop and possibly sell. The companies also will team to study an additional use for Forteo in fracture healing. Forteo is approved to help build new bone in osteoporosis patients. It generated $216.1 million in sales during the first quarter. Lilly and Synthes also will co-promote Forteo to U.S. orthopedic surgeons, who treat patients with fractures due to osteoporosis. Synthes specializes in developing and selling instruments, implants and biomaterials to fix bone and soft tissues. U.S. prosecutors in Philadelphia are seeking prison time for some former Synthes executives who have pleaded guilty to misdemeanors tied to allegations that company representatives pushed a bone-cement product for an unapproved use. Lilly spokeswoman Tammy Hull noted that the executives are no longer with the company and Lilly was excited about working with Synthes.
(Source: http://www.dddmag.com/news-Lilly-Signs-Forteo-Promotion-Deal-61011.aspx │“Lilly Signs Forteo Promotion Deal” │ Drug Discovery & Development - June 10, 2011 │Primary source: Associated Press – Indianapolis │Jun. 9, 2011)

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CHRONICLE SPOTLIGHT
J&J ORDERED TO PAY $327 MILLION OVER DECEPTIVE RISPERDAL MARKETING CLAIMS
A

JUNE 2011

Johnson & Johnson unit was ordered by a South Carolina judge to pay more than $327 million in penalties for deceptively marketing the antipsychotic drug Risperdal as safer and better than competing medicines. J&J’s Ortho-McNeil-Janssen Pharmaceuticals unit repeatedly violated the state’s consumer-protection laws by sending a 2003 letter to doctors touting Risperdal as superior to rival drugs and including deceptive information in the product’s warning label, Judge Roger Couch in Spartanburg, South Carolina, concluded. The drugmaker’s executives “allowed the profit-at-all- costs mentality to cloud” their judgment in connection with the drug’s marketing campaign and its labeling, Couch said in his 17-page ruling. Janssen official said on Jun. 3, 2011 they will appeal Couch’s order and maintained the company fully disclosed Risperdal’s health risks and properly marketed the antipsychotic medicine. “We don’t believe that the dissemination of an FDA- approved package insert constitutes a violation of the South Carolina Trade Practices Act,” Kara Russell, a spokeswoman for Janssen said in an e-mailed statement. “We do not believe the ruling can be upheld on appeal.” South Carolina’s lawyers, who originally sued the J&J unit in 2007 for making misleading claims about Risperdal, sought billions of dollars in penalties over the targeted marketing and labeling material.

SALES DECLINE
Risperdal’s global sales peaked at $4.5 billion in 2007 and declined after the company lost patent protection. The drug generated $3.4 billion in sales in 2008, or 5.4 percent of New Brunswick, New Jersey-based J&J’s total revenue, according to company filings. Sales of the drug fell to $527 million last year, according to a January earnings report. Risperdal Consta, the long-acting version of the antipsychotic drug, generated $1.5 billion in sales last year for J&J. The state’s case centered on drug-safety claims that J&J and Janssen made in November 2003 correspondence to about 700,000 doctors across the U.S., including more than 7,000 in South Carolina. The U.S. Food and Drug Administration responded with a warning letter saying J&J made false and misleading claims that minimized the potentially fatal risks of diabetes and overstated the drug’s superiority to competing products. South Carolina’s lawyers argued during a two-week trial of the state’s suit that Risperdal’s safety label also downplayed diabetes and other health risks.

‘CLEVER EFFORT’
The faulty labels were included in as many as 722,000 Risperdal prescriptions written in South Carolina from 1994 to 2007, the state’s lawyers told Couch at an April hearing. The deceptive information also was presented in 183,144 sales calls on doctors by Janssen drug representatives, and 496,565 sample boxes distributed over that 13-year period, South Carolina’s lawyers argued. In his ruling, Couch found the Risperdal letter to South Carolina doctors was a “clever effort” to “manipulate the message” about the drug. He concluded penalties were warranted for 7,180 letters Janssen officials mailed to physicians in the state along with another 36,372 instances in which the drugmaker’s salespeople used the missive to market Risperdal in person, according to court records.

$4,000 PER VIOLATION
Couch awarded South Carolina a total of $174.2 million in penalties over the letter based on a rate of $4,000 per violation of the state’s consumerprotection laws, according to his ruling. He also found 509,499 sample boxes of Risperdal distributed in the state contained labels with deceptive materials that warranted penalties. The judge awarded the state $152.8 million in penalties over the label at a rate of $300 per violation. J&J’s lawyers claimed in court papers that the state engaged in “triple counting” by seeking to have prescriptions, marketing letters and sales calls on individual doctors included as violations. Penalizing the drugmaker for multiple contacts with doctors who were allegedly “misled or deceived each time he or she had been exposed to” the targeted information would be unfair, Steven Pugh, one of the company’s attorneys, said in May 3 filing.

HOLD THEM ACCOUNTABLE
The award puts drugmakers on notice that if they “try to spin information or try to see what they can get away with,” state officials will hold them accountable, Donald Coggins, a Spartanburg-based lawyer who represented the state, said in an interview on Jun. 3, 2011. The case is the third of about 10 state lawsuits to be considered by jurors over J&J’s Risperdal marketing campaigns. In June, J&J won dismissal of Pennsylvania’s suit alleging the company hid the drug’s diabetes risk and tricked regulators into paying millions more than they should have for the medicine. A Louisiana jury in October ordered the drugmaker to pay $257.7 million in damages to that state for making misleading claims about Risperdal’s safety. A judge later added $73 million in legal fees to the award. A West Virginia judge in a 2009 non-jury trial awarded $3.95 million, finding the company misled doctors about the risks and benefits of Risperdal. The state dropped its Risperdal claim after J&J won an appeal, company officials said in February. (Source: http://www.bloomberg.com/news/2011-06-03/j-j-ordered-to-pay-327-million-on-deceptive-marketing-claims.html │“J&J Ordered to Pay $327 Million Over Deceptive Risperdal Marketing Claims” by Jef Feeley and Steven Church │Edited by Michael Hytha - Jun 4, 2011)

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CHRONICLE SPOTLIGHT
MYLAN
PL ANS DI RE CT E NT RY I NT O I N DI AN MAR KE T

JUNE 2011

Mylan, a generic-drug manufacturer, announced that it will be rebranding its Hyderabad, India-based subsidiary, Matrix Laboratories, as Mylan.
In a company press release, Mylan Chairman and CEO Robert J. Coury states, “This rebranding will lay the groundwork for continued expansion in India through our entry into the Indian commercial market with our own prescription pharmaceuticals within the next 12 months.” Matrix Laboratories is a supplier of active pharmaceutical ingredients (APIs), and a producer of APIs used to make generic antiretroviral therapies for the treatment of HIV/AIDS. Mylan acquired 51.5% of Matrix’s shares in 2007, and the remainder of its shares in 2009. Matrix has a workforce of more than 7000 in India, including more than 900 scientists within its research and development division who work on projects ranging from the development of APIs, to innovations for immediate- and controlled-release solid oral doses. In order to support its continued growth in India, Mylan expects to significantly increase its workforce there. Coury states in the press release, that, “[T]o support the commercial launch and other growth opportunities in India, we expect to continue to expand our workforce significantly over the coming years and aim to attract the highest caliber talent both from within India and internationally. As we grow, we will continue to apply our global standards of excellence to our operations around the world.” The planned name change is subject to approval of the Registrar of Companies in India.
(Source: http://biopharminternational.findpharma.com/biopharm/News/Mylan-Plans-Direct-Entry-Into-Indian-Market/ArticleStandard/Article/ detail/725706?contextCategoryId=435 │“Mylan Plans Direct Entry Into Indian Market” by Amy Ritter │BioPharm Bulletin - Jun. 7, 2011)

LANNETT EXPECTS FDA DECISION THIS MONTH ON MORPHINE PRODUCT
Lannett Co. Inc. expects to receive a decision from the Food and Drug Administration on the company’s new drug application for its morphine
sulfate oral solution product on June 23. The Northeast Philadelphia generic drug company had to stop selling the pain relief medicine last year as part of an FDA crackdown on older drugs that had entered the market prior to the FDA’s regulatory review requirements now imposed on all new drug candidates. Lannett last year sued the federal agency alleging its product should be exempt from that process. Lannett has sold morphine sulfate for five years; it accounted for about 2 percent of the company’s $119 million in sales in 2009. The use of the pain medicine in the United States goes back more than 150 years. Simultaneous with its legal battle, the company prepared a new drug application for its morphine sulfate product, which it submitted to the FDA last year. “We are preparing for the re-launch of our morphine sulfate oral solution product, if approved,” said Arthur Bedrosian, president and chief executive officer of Lannett.
(Source: http://www.bizjournals.com/philadelphia/news/2011/06/07/lannett-expects-fda-decision-this.html │“Lannett expects FDA decision this month on morphine product” by John George, Staff Writer │ Philadelphia Business Journal – Jun. 7, 2011)

B IOG E N

IDE C S AYS E U RE G UL AT ORS APPROV E D AV ONE X PEN

Biogen says European Union regulators approved once-a-week injection pen for MS.
Biogen Idec Inc. said on Jun. 7, 2011 that European Union regulators approved an injectable pen version of its multiple sclerosis drug Avonex. The Avonex Pen is approved for patients who have experienced the first symptoms of MS, or who have the relapsing form of the disease. The pens are single-use pens with a dose that lasts one week. Biogen Idec said it will start making the pens available in Europe over the next few weeks. Avonex is the Weston, Mass., company's biggest selling drug. Worldwide sales of Avonex totaled $2.52 billion in 2010. (Source: http://finance.yahoo.com/news/Biogen-Idec-says-EU-apf-3572288821.html?x=0&.v=1 │“Biogen Idec says EU regulators approved Avonex pen” │New York - Associated Press │ Jun. 7, 2011)

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P FIZER TO CUT ANOTHER $1 BILLION IN EXPENSES

JUNE 2011

Faced with growing generic competition and an insufficient pipeline, Pfizer execs are scrambling some more and plan to cut another $1 billion or so in
expenses on top of the billions in cuts that have already been drained from R&D and marketing over the past few years, The Wall Street Journal reports.

The first phase of the cutbacks will amount to $500 million and take place later this year, with the rest coming next year. “We’re going to take out another billion dollars of our expenses,” Pfizer ceo Ian Read was quoted as saying, according to the paper. A Pfizer spokesman adds that “we’re focused on operating in new, more effective and efficient ways, while at the same time continuing to invest where opportunities are robust.”
Among the areas to be cut: duplicative administrative work at Pfizer’s New York headquarters and offices elsewhere, promotion, travel, entertainment and consultants, as well as materials, supplies and electronic devices for sales reps. The cuts would trim almost 5 percent from selling, informational and administrative expenses, which were $19.6 billion last year, the paper writes.

Over the past few years, Pfizer has cut nearly 20,000-19,000 jobs to save costs and combine operations after acquiring Wyeth. Overall, Pfizer currently employs nearly 110,000 people. Last year at this time, Pfizer announced plans to slash 6,000. Since 2000, Pfizer has cut spending by $4.1 billion. Meanwhile, the Lipitor cholesterol pill, a $10.7 billion seller, begins facing generic competition this year. Last year, the Effexor antidepressant lost patent protection and next year, the Viagra impotence pill, a $1.9 billion seller, follows suit. Pfizer sales last year were nearly $68 billion. To cope, Pfizer is also considering the sale of so-called non-core units, including animal health, nutrition and consumer goods. The drugmaker already agreed to sell a unit that makes drugs in capsule form for $2.38 billion.
Some analysts, however, believe the move is misguided and will not transform either an established entity consisting of older, off-patent meds, or core products, which would be home to newer drugs and R&D, into growth operations. (Source: http://www.pharmalot.com/2011/06/pfizer-to-cut-another-1b-in-expenses/ │“Pfizer To Cut Another $1 Billion In Expenses” by Ed Silverman │Jun. 7, 2011)

IMPAX LABS GETS FDA WARNING ON MANUFACTURING
Generic drugmaker Impax Laboratories Inc.
manufacturing practices at its Hayward plant. The warning letter reported that during a review, FDA inspectors found problems in the company's sampling and testing, its production record review, and the process it used to determine why manufacturing batches did not meet quality specifications. Based on the inspection results, Impax recalled five production lots of the cholesterol drug fenofibrate in March. The FDA's inspection was conducted between Dec. 13 and Jan. 21. Impax said it reviewed its manufacturing practices after the inspection and will work to address the FDA's concerns. It is required to respond to the FDA's warning letter within 15 business days. The warning letter does not affect its ability to make and ship products, but the company said marketing applications that involve the Hayward plant could be delayed. Impax added that it reduced production at the Hayward plant so it could make changes, and it has now resumed production at a normal pace. (Source: http://www.dddmag.com/Impax-Labs-Gets-FDA-Warning-on-Manufacturing-060711.aspx │“Impax Labs Gets FDA Manufacturing” │ Drug Discovery & Development - June 07, 2011 │Primary source: Associated Press – Hayward, California) Warning on said on June 6 that it received a warning from the Food and Drug Administration (FDA) about

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AN ESSENTIAL SOURCE FOR PHARMA PROFESSIONALS

NEWS FROM THE GULF
GULF PHARMA REGISTRATION COMMITTEE DISCUSSES NEW DRUGS REGISTRATION
The
Gulf central pharmaceutical registration committee held its 53rd meeting to discuss the registration of new pharmaceutical products, re-registration of other items or new companies for the first time.

JUNE 2011

The meeting was held in Beach Rotana Hotel in Abu Dhabi in the attendance of Nasser Khalifa Al Budoor, Assistant Undersecretary and member of the executive board of the GCC ministers of health, Dr. Mohammed Al Haydery, Acting Director General of the Executive Board and head of the Central Pharmaceutical Registration Department in the GCC ministers of health council as well representatives of the council. At the beginning of the meeting, Nasser Khalifa Al Budoor, Assistant Undersecretary for External Relations in the Ministry of Health and member of the executive board of the GCC ministers of health council, welcomed the attendees reassuring the necessity of providing safe and high quality drugs with fewer prices to be available to all patients. Al Budoor said, “The ministers of health council gives great concern to the central pharmaceutical registration system which would lead to the unification of the GCC’s efforts, procedures ad systems and common interests between the gulf member states. Such efforts will ensure the availability of drugs and pharmaceutical drugs or items for the residents of the region easily and smoothly”. He also emphasized that the quality and safety of drugs beginning from its manufacturing process to marketing, enable the gulf health sectors to help the community members use the best quality of medicines. Thus, the supervision role of the competent authorities in the ministries of health ensures the availability of safe drugs in the market with fewer costs. The obvious benefits for the registration of pharmaceuticals to facilitate the application of the Customs Union, which facilitates the movement of drugs across all ports between the States and the emergence of the early warning system to withdraw any medication if proven toxicity in any Member State, and the creation of a unified database accessible by the staff of the health sector. Al Budoor added that the benefits of drugs unified registration systems would facilitate the application of the unified customs system through the exit points in the GCC countries. The early warning system ensures the withdrawal of any drug across the ports of the member state countries and the creation of a unified gulf database that would serve the health sector in the region. Al Budoor added that the unified pharmaceutical drug system would also reduce the financial cost of the pharmaceutical registration analysis. “Our cooperation with the World Health Organization and FDA as well as the Saudi Food and Nutrition General Authority aims for implementing developed pharmaceutical practices and activating the program visits to the pharmaceutical factories. Such cooperation also targets the development of drugs manufacturing systems. The GCC ministers of health agreed in their last meeting in Geneva to stipulate unified gulf drugs price lists”, he added. Furthermore, Dr. Mohammed Al Haydery, Head of Pharmaceutical Registration Department emphasized that the committee discussed all matters related to the registration of new drugs, new pharmaceutical companies and re-registration of products. The committee is very keen to centralize the drugs registration procedures to achieve health quality and safety of drugs in the region.
(Source: http://www.moh.gov.ae/en/News/Pages/Gulf-Central-PharmaceuticalRegistration-Committee.aspx “Gulf Central Pharmaceutical Registration Committee Discusses New Drugs Registration | May 31, 2011)
Pharmaceutical Solutions Industry Tel: +966 2 6361383 │Fax: 966 2 6379460 │ P.O. Box 17476 │Jeddah 21484 │Kingdom of Saudi Arabia. For more info, visit www.psi.com.sa

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INSIGHTS
THE
L
WORLD’S BIGGEST R&D SPENDERS
ast year the top 10 R&D spenders in the biopharma world shelled out a record $67.41 billion on drug development, with big acquisitions and bold trial plans upping the ante on what it takes to mount a major pipeline effort these days. Analyzing the annual statements of the world's largest pharma companies, which provide the lion's share of the world's research budgets, FierceBiotech found that despite considerable cuts in a number of R&D operations, the Top 10 players saw a collective jump of more than 10 percent in R&D spending. And despite plans by Pfizer--Number One in R&D spending in 2010--to force through a major restructuring in R&D, this year Big Pharma will still be a big spender when it comes to drug research.

JUNE 2011

Analysts have been driving home the reasons for the R&D spending burst for several years now. Patent cliffs loomed on the drug world's biggest treatments. Pharma responded with some big acquisitions as well as plenty of homegrown programs to locate replacements as generic competition prepared to slice away revenue. And these big companies had the cash on hand to spend.
For some, these expansive strategies have worked fairly well. For many others, though, there has been little to show for the billions invested in the pipeline. As a result, the word from the R&D world these days is that it is time to catch fish--or find a different rod that doesn't cost so much.

"Our industry is taking too long, we're spending too much and we're producing far too little," said Eli Lilly CEO John Lechleiter recently, echoing a criticism that has been directed straight at Indianapolis for the past two years. And it is all happening at a time when the science of drug discovery and development has never been better. The R&D model is changing dramatically, says Joe Hammang, Pfizer senior director, worldwide science policy. Development is becoming more collaborative, he adds. But it is also becoming decidedly harder to win an approval at the FDA or the EMA. "As consumers we all want safe products," Hammang tells FierceBiotech, "and the increased regulatory pressure and expectations of drugs without side effects is bringing this significant pressure to the biopharmaceutical industry. It is not meant as a criticism. That regulatory body is very strict in terms of what is expected, which is often not discussed when we talk about productivity." "If you look at INDs (investigational new drug applications), the number hasn't really dropped off over the years," notes Eric Utt, Pfizer's director of science policy. But these new drugs "are failing the objective of the study. Some are not as efficacious, for others there is the increased stringency that these drugs are being measured by. The bar has been set much higher for us."
Sanofi and others, meanwhile, have been rolling out their own development strategies and pushing for a new mindset that encourages an enlightened attitude toward outsourcing. And while Pfizer will attempt to lead the way in dramatically reducing R&D costs, there's no sign that any of the other big spenders will follow suit--yet. Roche, Merck, Novartis and others have outlined ambitious development schedules for 2011. But this year, say the R&D chiefs, push will come to shove. New drugs must get past Phase III and developers will have to do better than the nine percent success rate it has for drugs that enter the clinic. There are quite a few late-stage programs that promise to do just that. In 2011, pharma has to keep its promise, or make fresh pledges about how it plans to spend investors' money. (Source: http://www.fiercebiotech.com/special-reports/worlds-biggest-rd-spenders │ “The worldʹs biggest R&D spenders” by John Carroll │Mar. 8, 2011)

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ANALYSIS
C OFFEE ADDICT ION CUTS PROS T RAT E CANCER RIS K
en who drink abnormally large amounts of coffee everyday are at lower risk of prostate cancer and much lower risk of lethal prostate cancer, according to a new study by researchers at Harvard University.

JUNE 2011

QUOTE & UNQUOTE
“Employees need to feel that their work is meaningful and that they are making a contribution to the company as well as building their career. Forward-thinking companies retain talented people and keep them engaged and recognized.”

M

Men who consumed six or more cups per day had a lower adjusted relative risk for overall prostate cancer compared with nondrinkers. The association was stronger for lethal prostate cancer. The average level of daily coffee consumption is slightly less than two cups, according to the study. Kathryn Wilson, a professor of epidemiology at Harvard’s School of Public Health, was the lead author of the study, “Coffee Consumption and Prostate Cancer Risk,” which appears in the most recent issue of the Journal of the National Cancer Institute published by Oxford University Press. Ironically, the potential health benefits associated with heavy coffee consumption appear to be related to non-caffeine components of coffee.

Matthew C. West Vice President, Chief Talent Officer, RCW Group
(Abstract from the source: http:// www.pm360online.com/f4_0211 │“THINK TANK: How Do You Keep Your Best Employees Happy?” │PM360 February 2011)

FROM THE STUDY:
Coffee contains many biologically active compounds, including caffeine and phenolic acids that have potent antioxidant activity and can affect glucose metabolism and sex hormone levels. Because of these biological activities, coffee may be associated with a reduced risk of prostate cancer. We conducted a prospective analysis of 47 911 men in the Health Professionals Follow-up Study who reported intake of regular and decaffeinated coffee in 1986 and every 4 years thereafter.

“By de-linking research and development incentives from product prices, and by eliminating legal monopolies to sell products, it is possible to induce investments that are medically more important, procure products at low prices from competitive suppliers, radically lower pricing barriers for access to new medicines, reduce wasteful marketing and research and development activities, and dramatically lower the overall costs of acquiring innovation, while expanding access to that innovation.”
(Abstract from the source: http:// www.pharmalot.com/2011/06/prizes-not-patents-fordrug-discovery-2/ │“Prizes, Not Patents, For Drug Discovery?” by Ed Silverman │Jun. 2, 2011) “For each of our strategic partnerships, we invest a fair amount of time, resources, and energy to put a mechanism and an infrastructure in place that allows us to execute within a framework that the client is happy with, so everybody knows what is supposed to be done by whom.”

From 1986 to 2006, 5035 patients with prostate cancer were identified, including 642 patients with lethal prostate cancers, defined as fatal or metastatic . . . We observed a
strong inverse association between coffee consumption and risk of lethal prostate cancer.

The association appears to be related to non-caffeine components of coffee.
(Source: http://blogs.forbes.com/williampentland/2011/05/28/coffee-addiction-cutscancer-risk/?partner=yahootix │“Coffee Addiction Cuts Cancer Risk” by William Pentland │May 28, 2011)

Josef von Rickenbach, CEO, PAREXEL.
(Source: http://www.lifescienceleader.com/index.php? option=com_jambozine&layout=article&view=page&aid=4 276&Itemid=56 │“Strategic Alliances: The Cure For What Ails Pharma?” by Sara Gambrill │Life Science Leader – May 2011)

DID YOU KNOW?
A b o u t Renal Cell Carcinoma: Each year, approximately 210,000 people worldwide are diagnosed with kidney cancer and nearly 102,000 people are expected to die from the disease. Within the last five years, great advances have been made in the treatment of patients with advanced RCC (Renal Cell Carcinoma), the most prevalent form of kidney cancer. However, five-year survival rates for patients with advanced RCC remain low, at around 20 percent.
(Abstract from the source: http://www.pharmaceuticalonline.com/article.mvc/Pfizer-Files-ForEuropean-Regulatory-Review-0001? sectionCode=Freeform1&templateCode=Standard2&user=20&source=nl:30987 │“Pfizer Files For European Regulatory Review Of Axitinib For Patients With Advanced Renal Cell Carcinoma” │Business Wire – New York │Jun. 1, 2011)

“A reputation is any set of beliefs that an audience holds about an individual or organization. What makes things complicated is that the audience is not homogeneous but a diverse population with varying interests and histories. So a reputation usually is a multifaceted set of beliefs. The same organization can have a good cop face, a bad cop face, or a facilitator face, and can show different faces to different audiences.”
(Abstract from the source: │ “Science and Politics at the FDA” by Walter Armstrong │Pharmaceutical Executive – Nov. 1, 2010)

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PRODUCT LAUNCH
ELDER PHARMA TO SELL INDIAN BRANDS IN EUROPEAN MARKET
Drug maker Elder Pharmaceuticals Ltd (www.elderindia.com)

JUNE 2011

will soon roll out its leading Indian brands in the European market through its subsidiaries in Britain and Bulgaria , to step up its exports in the region, the company said on Jun. 7, 2011.

"We plan to launch five products in Europe during this fiscal (2011-12) through our Bugarian subsidiary Elder Biomedia, which has secured approvals to market them in the region," Elder Pharmaceuticals director Alok Saxena said in a statement. Of the five products to be exported, Shelcal, a calcium supplement for women, is one of the largest selling pharma brands in the country, contributing Rs.200 crore to the company's sales turnover of Rs.800 crore in fiscal 2010-11. The Rs.800-crore Delhi-based Elder plans to double its export revenue to 20 percent over the next two years from 10 percent last fiscal by foraying into the European market in a big way. "We plan to unveil about 40 products in the domestic and overseas markets for pain management, women healthcare, skin care and neutraceuticals. Of these products, five will be in-licensed products of multinationals," Saxena said but did not name the multinationals. Women's healthcare and supplement food products (nutraceuticals) segments at 18-20 percent annually in the domestic market as against 12-13 percent growth of the overall pharma sector, the statement noted.
The company has seven manufacturing plants in located in Maharashtra, Uttarakhand and Himachal Pradesh.

Its research and development centre at Navi Mumbai is recognized by the department of scientific and industrial research under the ministry of science and technology.
(Source: http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/elder-pharma-to-sell-indian-brands-in-europeanmarket/articleshow/8764160.cms │“Elder Pharma to sell Indian brands in European market” │Bangalore, INDIA – Jun. 7, 2011)

D R.
D

REDDY’S LABS LAUNCHES THREE GENERIC PRODUCTS IN USA

r Reddy's Laboratories announced on Jun. 6, 2011 that it launched three generic drugs in the US market. The drugs are used to treat central nervous system disorders and were all approved by the US drug regulator in the last two weeks. Donepezil Hydrochloride tablets is a remake of Japan based Eisai Pharma's Aricept and its sale in the US alone fetched the company over $ 2 billion for the financial year 2011. The Food & Drug Administration (FDA) approved Dr. Reddy’s ANDA for Donepezil HCl tablets on May 31, 2011. The drug is available in 5mg and 10mg strengths in 30, 90 and 500 count bottles.

The second drug released- Venlafaxine Hydrochloride Extended Release capsules- is a copy cat of Wyeth's Effexor XR ® and is used to treat depression and social anxiety. Dr. Reddy’s will be competing with bigger generic players like Mylan and Teva who are their version of this drug in the US.
The Food & Drug Administration (FDA) approved Dr. Reddy’s ANDA for Venlafaxine Hydrochloride Extended Release Capsules on May 05, 2011. Effexor accounted for $ 2.3 billion of Wyeth's total sales. All three strengths of Dr. Reddy’s Venlafaxine Hydrochloride Extended Release Capsules are available in 30, 90 and 500 count bottles. Letrozole tablets, available in 2.5 mg potency, are a cheaper (bioequivalent generic) version of Novartis' Femara ® and are used to treat

menopausal disorders.
The Food & Drug Administration (FDA) approved Dr. Reddy’s ANDA for Letrozole tablets, USP on June 3, 2011. According to IMS Health, the pharmaceutical intelligence firm, Femara clocked in sales of $ 720 million in US in the last financial year. Dr. Reddy’s Letrozole tablets, USP are

available in 30 count bottles.
(Source: http://articles.economictimes.indiatimes.com/2011-06-06/news/29626039_1_donepezil-hydrochloride-release-capsules-teva │“Dr Reddy’s Labs launches three generic products in USA” by Deepika Amirapu, ET Bureau │Hyderabad, INDIA – Jun. 6, 2011│Additional text from www.drreddys.com )

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FEATURE
ASTRAZENECA PULLS PLUG ON FREE TRIPS FOR DOCTORS
⇒ ⇒ ⇒ ⇒

JUNE 2011

Ends payments for medics to attend international meetings Move may pressure rival companies to follow suit Industry under scrutiny over financial ties with doctors U.S. and UK bribery laws heighten compliance concerns

In an industry first, drugmaker AstraZeneca is scrapping payments for doctors to attend international medical congresses. The move follows
increased scrutiny of the $850 billion-a-year industry's potentially undue influence on prescribers and could put pressure on rivals to follow suit. AstraZeneca chief executive David Brennan announced the change of policy in low-key fashion at an industry conference in Istanbul earlier this month. "We have decided that we will no longer pay for doctors to attend international scientific and medical congresses but will instead focus our educational efforts on local educational opportunities for healthcare professionals," he said. As healthcare costs rise worldwide, concern has grown about financial ties between doctors and drugmakers. That has already led to bans on lavish entertainment and the end to a range of free-gifts from pens to mugs to computer accessories. AstraZeneca’s decision to stop paying for medics to fly to international medical and scientific meetings has taken things to a new level.

DRAMATIC CHANGE
European and U.S. congresses on topics like cancer, heart disease and diabetes typically see planeloads of specialist physicians flown in at Big Pharma's expense to hear the latest research in their area. "It is a dramatic change," Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations, said of the AstraZeneca move. "It is another sign that industry is changing its scientific education practices and I am sure you will see more moves of a similar nature by other companies," Bergstrom told Reuters. Brennan said he took the step because AstraZeneca should not do anything that could be seen as an inducement to prescribers to use its products. "We start from the position that our products stand on their own merits." Although the move will save money, the decision was not taken on cost grounds and any savings would have no significant impact on the company's bottom line, a company spokeswoman said. AstraZeneca had sales last year of $33.3 billion and made a core operating profit of $13.6 billion. Its action may carry additional weight because of Brennan's role as president of the industry's global lobby group, the International Federation of Pharmaceutical Manufacturers and Associations. It came at time of unprecedented regulatory pressure on the drugs industry, which in the past five years has paid $15 billion penalties to the U.S. government alone for alleged violations of laws and regulations. That scrutiny has been ramped up with a wave of investigations under the U.S. Foreign Corrupt Practices Act (FCPA) and the introduction of a new bribery act in Britain. Bribery legislation is an issue for pharmaceutical companies because doctors can be seen as government officials in those countries where they work for state-funded health systems. So, payments to them could trigger questions over corruption. Johnson & Johnson last month agreed to pay $78 million to settle British and U.S. charges it paid bribes and kickbacks to win business overseas, in the first settlement by a big drug company since the United States began scrutinizing the industry under the FCPA more than a year ago. AstraZeneca itself is being investigated by the U.S. Department of Justice and the Securities and Exchange Commission in connection with the FCPA. The company said last month it was looking into inappropriate conduct in countries including China.
(Source: http://www.reuters.com/article/2011/05/27/astrazeneca-junkets-idUSLDE74P1YI20110527? feedType=RSS&feedName=rbssHealthcareNews&rpc=43 │“AstraZeneca pulls plug on free trips for doctors” by Ben Hirschler; Editing by Dan Lalor │ Reuters – London │ May 27, 2011)

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PHARMA CHRONICLE
AN ESSENTIAL SOURCE FOR PHARMA PROFESSIONALS

DRUG MARKET
A
SNAPSHOT OF THE CHOLESTEROL DRUG MARKET

JUNE 2011

The news that Niaspan had failed to prevent heart procedures in a big government study last week has me thinking about cholesterol drugs a
lot. A really quick, simple question: what does the market for cholesterol drugs look like these days, as we near the expiration on the patent for Lipitor? For a quick simple answer, I went to IMS Health, which tracks prescription data. IMS provided me with annual prescription data for top cholesterol drugs going back five years and I assembled that data into the graph below. The graph shows prescriptions, not dollar sales, and this strips away all the noise caused by price increases to show overall use. It shows pretty dramatically how much things have been changing over the past few years. Look how quickly generic simvastation, which used to be sold as Zocor by Merck, have taken over the lion’s share of the market — which explains the decline in the use of Lipitor, which has remained the best-selling drug in the world. You can also see the precipitous decline in the use of ezetimibe, the active ingredient in both Vytorin and Zetia, over controversy over its effectiveness at preventing heart attacks. (I have combined Zetia into one line; I have done the same with the various versions of fenofibrate and with Niaspan and related combo pills.) You can see that even though its use had been increasing, Niaspan, made by Abbott Laboratories, was a pretty small player. (It is the pink line at the bottom of the chart.) So has GlaxoSmithKline’s fish oil pill Lovaza, despite its clear ascent. (Good news for Amarin, which is developing the next fish oil drug.) The biggest winner? AstraZeneca’s Crestor. But even it is hugging the bottom of the chart. No new cholesterol drug has come close to generating the kind of mass-market use we saw with Lipitor and Zocor.

(Source: http://blogs.forbes.com/matthewherper/2011/06/01/a-snapshot-of-the-cholesterol-drug-market/ │“A Snapshot Of The Cholesterol Drug Market” by Matthew Herper │Jun. 1, 2011)

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NEWS UPDATE
WHAT
GL A XO G AVE T O DOCT O RS UN DE R

JUNE 2011

Amid growing scandal over freebies lavished on Australian health department workers, GlaxoSmithKline has become the first drugmaker to reveal
the amount of money spent on doctors and health organizations in the land Down Under. Slightly more than $2 million was doled out last year, and the amount was about evenly split between the public and private sectors.

According to the West Australian:
⇒ ⇒ ⇒ ⇒

Of the total, $371,659 was spent on individual grants to healthcare professionals to attend domestic and overseas conferences; About $775,000 was paid for consulting, speaking, clinical trial work, advisory boards and medical copywriting; While more than $900,000 was used for sponsorships, donations and grants to health-related organizations. There was no breakdown, though, for money spent on public health departments.

Glaxo’s medical director in the region, Camilla Chong, says the payments were not inducements to prescribe drugs, but part of building close relationships. “There’s no point in us developing clinical studies based on what we know. We need to make sure they absolutely make clinical sense, have practical value at the patient end and that’s why these close working relationships are absolutely important,” she tells the paper. “It’s about attaining what’s best for the development of the medicine for the patient, ultimately.” The disclosure comes two weeks after the paper reported more than $1.4 million worth of gifts from drug and other health companies were accepted by WA Health Department employees between December 2009 and April 2011, including more than 350 trips to cities including Vienna and Brussels. Departmental “sponsored travel” is under review by Auditor General Colin Murphy. The $2 million, by the way, is a pittance compared to what Glaxo spent last year in the US on doctors - a total of more than $96 million. In fact, the amount spent on docs and other healthcare professionals in each of more than a dozen states was higher than what was reported in Australia, according to this database compiled by ProPublica.
(Source: http://www.pharmalot.com/2011/06/what-glaxo-gave-to-doctors-down-under/? utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Pharmalot+%28Pharmalot%29 │ “What Glaxo Gave To Doctors Down Under” by Ed Silverman │ June 7th, 2011)

E U APPROVES LUCENTIS FOR BLOCKED RETINAL VEINS
Novartis gets European approval for Lucentis as treatment for blocked retinal veins .
Swiss drug maker Novartis says it has received European Union approval for its eye drug Lucentis to be used as a treatment for vision loss caused by blocked retinal veins. Basel-based Novartis AG said on Jun. 6, 2011 the European Commission approved Lucentis as a treatment for macular edema, or swelling of the central part of the retina, because of a blocked vein in the retina. The U.S. Food and Drug Administration approved Lucentis last year to treat the swelling, which usually affect people over 50. The drug is already approved as a treatment for neurovascular, or "wet," age-related macular degeneration. Novartis has the right to sell Lucentis outside the U.S., where it is marketed by rival Roche Group's subsidiary Genentech. (Source: http://finance.yahoo.com/news/EU-approves-Lucentis-for-apf-1906664599.html?x=0&.v=1 │“EU approves Lucentis for blocked retinal veins” │Geneva – Associated Press │Jun. 6, 2011)

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NEWS UPDATE
ASTRAZENECA PAYS $250K FOR SEX DISCRIMINATION

JUNE 2011

AstraZeneca will pay $250,000 to 124 women who were subjected to pay discrimination while working at an office in Wayne, Pennsylvania, according
to the US Department of Labor, which filed a lawsuit last year alleging the drugmaker discriminated against female sales reps by paying them salaries that were, on average, $1,700 less than their male counterparts.

The department’s Office of Federal Contract Compliance Programs conducted a scheduled compliance review of the business center in 2002 and found that AstraZeneca had violated Executive Order 11246 by failing to meet its obligations as a federal contractor to ensure employees were
paid fairly without regard to sex, race, color, religion and national origin.

AstraZeneca holds a contract valued at more than $2 billion with the US Department of Veterans Affairs to provide drugs to hospitals nationwide. “Forty-eight years after President Kennedy signed the Equal Pay Act, women are still fighting for fundamental fairness when it comes to how we are paid,” OFCCP director Patricia Shiu, a member of President Obama’s National Equal Pay Enforcement Task Force, says in a statement. “I am glad AstraZeneca finally has agreed to pay its employees what they’ve earned. More importantly, we look forward to working with the company’s management to make sure this does not happen again to anyone who works for AstraZeneca.” Under a consent decree, the drugmaker also agreed to conduct a statistical analysis of the base pay of 415 individuals employed full time as “primary care” and “specialty care” level III sales specialists in Alabama, Delaware, Indiana, Kentucky, Maryland, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Virginia, West Virginia and the District of Columbia. If the analysis concludes that female
employees continue to be underpaid, salaries will be adjusted, DOL states.

Finally, AstraZeneca has agreed to develop and annually update its affirmative action plan and keep all supporting documentation as required by law. If the company fails to comply with the consent decree, it may be subject to sanctions, including cancellation of its current federal contract and debarment from acquiring future ones. An AstraZeneca spokesman sends us this statement, “We reached this agreement to resolve the matter
without further legal proceedings. We are confident that our compensation practices then and now are fair and non-discriminatory – and this settlement supports our position.” (Source: http://www.pharmalot.com/2011/06/astrazeneca-pays-250k-for-sex-discrimination/ │“AstraZeneca Pays $250K For Sex Discrimination” by Ed Silverman │Jun. 6, 2011)

C OS T SAV IN GS RE AS ON F OR 60 % OF OUTS OURCING
U.S. largest regional market for contract manufacturing.
While 54.5% of pharma and biopharm companies outsource less than half of their global manufacturing, 18.2% currently use outsourcing for at least 91% of their output, according to a recent survey by Pharma IQ.
Interestingly, the U.S. represents the largest regional market for contract manufacturing. Europe comes in second with future growth expected from developing regions, especially Asia Pacific. " The Japanese market for pharmaceutical contract manufacturers is projected to register annual growth

rate of 12.8% during the next four years," according to the study. An earlier report from Global Industry Analysts predicted that the global pharmaceutical contract manufacturing market would reach a total value in excess of $40.7 billion by 2015.
The key factors driving such expansion included soaring demand for new drugs, increasing need for R&D productivity and efficiency, as well as the desire to make cost savings where possible. Another reason is that many pharma and biotech companies simply lack sufficient manufacturing capabilities internally.

In fact, the Pharma IQ research found that 70% of organizations cite lack of internal capacity as the number one reason for outsourcing some or all of their production. A shortage of expertise (45%) was listed a major reason for outsourced manufacturing. With regard to product type, the manufacture of finished form medicine is most commonly outsourced (7.27%), while 36.4% produce APIs and 31.8% manufacture biopharmaceuticals through external means.
(Source: http://www.industryweek.com/articles/cost_savings_reason_for_60_of_outsourced_pharma_and_bio_manufacturing_24758.aspx?SectionID=1 │“Cost Savings Reason for 60% of Outsourced Pharma and Bio Manufacturing” │Compiled by Adrienne Selko │Jun. 2, 2011)

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AN ESSENTIAL SOURCE FOR PHARMA PROFESSIONALS

NEWS UPDATE
MYLAN GETS NOD FOR GENERIC VERSION OF EFFEXOR XR ® C A P S U L E S
Pr o d u c t h a s s ta r te d t o s h i p .

JUNE 2011

Mylan Inc. on Jun. 2, 2011 announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl) Extended-release (ER) Capsules, 37.5 mg (base), 75 mg (base) and 150 mg (base), the generic version of Wyeth's Effexor XR® Capsules, which are used in the treatment of major depressive disorder and social anxiety disorder.

Mylan is launching these products through a previously announced settlement and license agreement entered into with Wyeth, which is now part of Pfizer. Venlafaxine HCl ER Capsules had U.S. sales of approximately $2.3 billion for the 12 months ending March 31, 2011, according to IMS Health. The product is being shipped to customers. Currently, Mylan has 164 ANDAs pending FDA approval representing $95.6 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2010, according to IMS Health. Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.
For more information about Mylan, please visit www.mylan.com For more information about generic drugs, please visit www.ChoosingGenerics.com

(Source: http://www.prnewswire.com/news-releases/mylan-receives-approval-for-generic-version-of-effexor-xr-capsules-123027388.html Receives Approval for Generic Version of Effexor XR® Capsules” │PRNewswire – Pittsburgh │Jun. 2, 2011)

│“Mylan

FDA AGREES FOR PRIORIT Y REVIEW OF ALEXION’S SOLARIS DRUG
ne day after discreetly disclosing donations of its costly drug to treat Germany's E coli victims, Alexion Pharmaceuticals Inc. in Cheshire says U.S. drug regulators have agreed to a speedy review of its application to market its blockbuster Soliris drug as a treatment for sufferers of another rare, potentially fatal blood ailment.

O

Alexion announced on Jun. 1, 2011 that the U.S. Food and Drug Administration has granted its request for priority review of its supplemental license application to use Soliris as a treatment for atypical Hemolytic Uremic Syndrome (aHUS). The FDA gives a priority review designation to drugs that may offer major advances in treatment, or provide a treatment where no adequate therapy exists, Alexion said. If approval is granted, Alexion anticipates that Soliris would be available for U.S. patients with aHUS in the fourth quarter of this year. Alexion also announced the European Medicines Agency is reviewing a marketing application for Soliris as a treatment for patients with aHUS in the European Union. Widening the global patient base for Soliris could mean hundreds of millions of dollars more in annual sales for Alexion, which sold more than a half-billion dollars worth of the drug worldwide in 2010. Alexion disclosed on May 31, 2011 that its six-figure drug developed to treat sufferers of a rare form of anemia is being distributed free to treat victims of the E coli outbreak sweeping Germany that has killed a dozen people and sickened hundreds more. Alexion told the public through federal securities regulators that its German subsidiary has been deluged with physician requests for eculizumab -- branded as Soliris -- to treat patients suffering from Shiga-toxin producing E. coli hemolytic uremic syndrome (STEC-HUS). The ailment is a potentially life-threatening outcome of Enterohaemorrhagic Escherichia coli (EHEC) infections in which blood cells are infected and can cause kidney failure, Alexion said. Although Soliris is not formally authorized to treat STEC-HUS, data from the emergency field trial could prove invaluable to drug investigators and regulators, observers say.
(Source: http://www.hartfordbusiness.com/news18758.html │“FDA has more good news for Alexion’s Soliris” by Gregory Seay │Jun. 1, 2011)

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NEWS UPDATE
AFFYMAX FILES FOR APPROVAL OF KIDNEY DISEASE DRUG
A

JUNE 2011

ffymax Inc. and its partner Takeda Pharmaceutical Co. Said on Jun. 7, 2011 they have asked regulators to approve a drug designed to treat anemia in patients with chronic kidney failure.

The companies asked the Food and Drug Administration to clear the way for marketing of their drug candidate peginesatide. It is intended to treat anemia in patients who have chronic kidney failure and are on dialysis. Affymax and Takeda previously called the drug candidate Hematide. Takeda, a Japanese drugmaker, has marketing rights outside the U.S.
FDA reviews typically take 10 months.

Affymax, of Palo Alto, Calif., and Takeda have also studied peginesatide in chronic kidney failure patients who were not on dialysis. While the drug met its goals in that study, the side effects were more severe for non-dialysis patients. The companies still face the threat of a lawsuit from health care giant Johnson & Johnson, whose drug Procrit is used to treat anemia in patients who are on dialysis for kidney failure or who are being treated for cancer. In October, an arbitrator ruled that Johnson & Johnson was the sole owner of a group of patents on those drugs. Affymax said it doesn't think the patent is valid and doesn't apply to Procrit or peginesatide, but the ruling could allow Johnson & Johnson to sue Affymax for patent infringement. Affymax said it plans to ask a federal court to overturn the arbitrator's decision. The decision applied to a patent and related applications in the U.S., Europe, Japan, Canada and Australia.
(Source: http://www.businessweek.com/ap/financialnews/D9NIHG000.htm │“Affymax files for approval of kidney disease drug” │New York – Associated Press │May 31, 2011)

J OHN S ON
J

& J O HN S ON UN V E IL S RE V IT AL I ZE D P IPE L IN E

ohnson & Johnson says it plan to seek approval for 11 new products and more than 30 important product line extensions between 2011 and 2015 as it emphasizes internal R&D investments, leverages strategic licensing, partnerships, and select acquisition deal to bolster its long-term outlook.

The company announced its plans at its first public pharmaceutical business review since 2009, giving investors a detailed overview of its pipeline and plans for growth. The company's pharmaceutical business lagged last year as patents expired on its antipsychotic Risperdal, and its seizure drug Topamax, opening those blockbusters to competition from generics and weighing on earnings. Now the company is showcasing what it calls a "revitalized portfolio" and highlighting its plans to build the business in five therapeutic areas: neuroscience, cardiovascular and metabolic disease; immunology, oncology,
and infectious diseases and vaccines.

Although Johnson & Johnson's revenue base is more diversified than many of its competitors, massive recalls for some of the company's most well-known consumer products, including nonprescription drugs such as Motrin and Children's Tylenol, have hurt growth. Nonetheless, the company anticipates that a revamped product portfolio and robust pipeline of prescription products will help it bring new drugs to market for Alzheimer's disease, stroke prevention, and HIV.
Johnson & Johnson's pharmaceuticals business generated $22.4 billion in 2010 sales, 36 percent of the company's total revenue. It ranks as the world's eighth largest pharmaceutical company and fifth largest biotech company. In 2010, it invested $4.4 billion on pharmaceuticals research and development focused on five therapeutic areas. The planned expansions and product launches will help position the company where it needs to be, says Sheri McCoy, vice chairman of the

company's executive committee. "The healthcare industry is undergoing dramatic change," says McCoy, "and with science evolving rapidly, we are well-positioned for the new demands, requirements, demographics and trends shaping the healthcare market."
(Source: http://seekingalpha.com/article/272230-johnson-johnson-unveils-revitalized-pipeline │“Johnson & Johnson Unveils Revitalized Pipeline” │The Burrill Report – May 27, 2011)

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NEWS UPDATE
MAP PHARMA SUBMITS NDA FOR MIGRAINE DRUG

JUNE 2011

MAP Pharmaceuticals, Inc. said on May 26, 2011 it has submitted a New Drug Application with the U.S. Food and Drug Administration for its migraine
drug Levadex. In an extended late-stage study, the orally inhaled drug showed statistically significant improvement in all four symptoms associated with the debilitating disorder.

The Mountain View, California-based company said the 505(b)(2) NDA submission for the potential acute treatment of migraine in adults included efficacy and safety data from the Phase 3 FREEDOM-301 clinical trial, in which patients self-administered Levadex at home using the company's proprietary Tempo inhaler. MAP said patients had statistically significant improvement at two hours compared to patients on placebo for all four co-primary endpoints, recurrent headaches, nausea, phonophobia or sensitivity to sound and photophobia or sensitivity to light. Pain relief was reported by 58.7 percent of patients who received Levadex compared with 34.5 percent for placebo. The 12 month open-label, safety extension of the trial was designed to evaluate overall safety of Levadex over six and 12 months of exposure. MAP said there were no drug related serious adverse events reported in any Levadex trial. In addition to the phase 3 trial data, the submission also included data from a pharmacokinetics or PK trial in smokers and non-smokers, a pharmacodynamics or PD trial evaluating the acute effects of Levadex on pulmonary artery pressure. In the PK study comparing smokers vs. non-smokers, systemic exposure to Levadex was not higher in smokers. In the PD study, there was no difference in pulmonary arterial systolic pressure between the Levadex and the placebo group over two hours. PK concentrations for Levadex in asthmatics were similar to those in healthy subjects. Timothy Nelson, president and chief executive officer, said, "This NDA submission marks a major corporate milestone for MAP Pharmaceuticals and brings us one step closer to our goal of providing the underserved migraine patient population with a potential new treatment option."
(Source: http://www.rttnews.com/Content/BiotechStory.aspx?Id=1633714&Category=PendingFDA │“MAP Pharma Submits NDA For Migraine Drug – Update” │RTTNews – May 26, 2011)

WATSON EXPANDS IN EUROPE WITH SPECIFAR DEAL
Watson Pharmaceuticals has acquired Greece-based Specifar Pharmaceuticals, the generic pharmaceutical developer, manufacturer and marketer
for €400m ($562m).

The acquisition adds to Watson's commercial presence in key European markets by providing a portfolio of approved products. The transaction also gives Watson a strong branded-generic commercial presence in the Greek pharmaceutical market. Specifar's pipeline includes a generic tablet version of Nexium (esomeprazole), which could launch in certain European markets as early as the fourth quarter of 2011. Under the terms of the acquisition agreement, Specifar's former owners could receive additional consideration based on future profits from this product. Paul Bisaro, Watson's president and chief executive, said, "The strategic significance of this combination is substantial. Watson will now have a powerful product development capability recognized throughout the industry for its strong track record of successfully launching products in key European markets, supported by an accomplished R&D and regulatory capability.” He continued, "The development business will continue to develop and market products to third parties under the Specifar name and now will also develop products for Watson’s commercial groups worldwide. In addition, we intend to expand Specifar's development capabilities and create a centre of excellence for product development in international markets. We also believe that Specifar's European management expertise and existing business relationships will support Watson's current and future commercial expansion in European countries." The Specifar group is in the top five in the Greek branded-generic market, with a portfolio of more than 30 products. It also markets products in Greece under the Alet Pharmaceuticals brand through a separate sales force.
(Source: http://www.pmlive.com/find_an_article/allarticles/categories/General/2011/may_2011/news/watson_expands_in_europe_with_specifar_deal │“Watson expands in Europe with Specifar deal” │May 26, 2011)

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FDA APPROVALS
FDA GIVES GENERIC XANAX XR MANUFACTURING NOD TO AUROBINDO PHARMA

JUNE 2011

The US Food and Drug Administration has given manufacturing and marketing approval for Alprazolam Extended-Release Tablets 0.5mg, 1mg, 2mg,
and 3mg to Aurobindo Pharma. Aurobindo's Alprazolam Extended-Release Tablets 0.5mg, 1mg, 2mg, and 3mg are generic equivalent to Pharmacia and Upjohn's Xanax XR tablets 0.5mg, 1mg, 2mg, and 3mg. Alprazolam Extended-Release Tablets are used as a treatment for disorder, with or without agoraphobia. Xanax XR Extended-Release Tablets are a benzodiazepine, which works by slowing down the movement of chemicals in the brain. This results in a reduction in nervous tension (anxiety). (Source: http://manufacturing.pharmaceutical-business-review.com/news/fda-gives-generic-xanax-xr-manufacturing-approval-to-aurobindo-pharma080611 │“FDA gives generic Xanax XR manufacturing approval to Aurobindo Pharma” by PBR Staff Writer │Jun. 8, 2011)

F DA
The

G RAN TS ORPHAN DRUG DE S IGN AT ION T O E DIS ON PHARMA’S E PI- 74 3

US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Edison Pharmaceuticals’ EPI-743 as a treatment for inherited mitochondrial respiratory chain diseases.

EPI-743, an orally absorbed small molecule that readily crosses into the central nervous system, works by targeting an enzyme NADPH quinone oxidoreductase 1 (NQO1). EPI-743 is in phase 2B/3 pivotal clinical trials. The FDA has given the orphan drug status on the basis of their review of the application which included clinical and pre-clinical data demonstrating a favorable efficacy and safety profile. Edison Pharma is a patient- and physician-founded company devoted to developing new medicines for rare and neglected diseases. Currently, Edison Pharma (www.edisonpharma.com) is working on inherited mitochondrial diseases for which there are no approved drugs. (Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-grants-odd-to-edison-pharma-epi-743-080611 │“FDA grants ODD to Edison Pharma EPI-743” by PBR Staff Writer │Jun. 8, 2011)

FDA

ALLOWS ACT AVIS T O MARKET GE NE RIC INS OMNIA DRUG

The US Food and Drug Administration (FDA) has allowed Actavis (www.actavis.us), an international generic pharmaceuticals company, to market
Zolpidem Tartrate Extended-Release Tablets USP, 12.5mg CIV. Distribution has already commenced. Actavis was the first company to launch Zolpidem Tartrate Extended-Release Tablets 6.25 mg strength in October 2010 with 180-day exclusivity. Zolpidem Tartrate Extended-Release Tablets, the generic equivalent of Ambien® CR , had US sales of approximately $793 million for the 12 months ending March 31, 2011, according to IMS Health. Sanofi-aventis' Ambien CR is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Actavis CEO Doug Boothe said the approval of Zolpidem ER Tablets 12.5 mg enables Actavis to offer both strengths to meet the needs of our customers. "This approval also underscores Actavis' emphasis and commitment to bringing complex controlled-release products to the marketplace to help improve patient access to pharmaceuticals," Boothe said.
For prescribing information, please click below

http://www.actavis.us/NR/rdonlyres/2F20F6D6-AEFE-43DA-AB27-6BD5216088F1/24509/ZolpidemTartrateExtendedReleaseTabletsUSPRev0211.pdf
(Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-allows-actavis-to-market-generic-insomnia-drug-070611 │“FDA allows Actavis to market generic insomnia drug” by PBR Staff Writer │Jun. 7, 2011)

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FDA APPROVALS
F DA CLEARS GENERIC ARICEPT MADE BY MYLAN INC.
Mylan is latest company to win approval for donepezil, generic for Aricept; starts shipping.

JUNE 2011

Mylan Inc. said on Jun. 7, 2011 it is now selling a lower-cost generic version of the Alzheimer's drug Aricept. Mylan starting shipping the product after receiving approval from the Food and Drug Administration. The drug lost patent protection in November and a slew of generic versions have been approved recently. Teva Pharmaceutical Industries Ltd. started selling a generic version on Jun. 1, 2011. The brand-name version of Aricept, or donepezil, is marketed by Pfizer Inc. and Eisai Co. of Japan. Mylan said U.S. sales of donepezil totaled $2.3 billion in the 12 months that ended March 31. (Source: http://finance.yahoo.com/news/FDA-clears-generic-Aricept-apf-3827744035.html?x=0&.v=1 │“FDA clears generic Aricept made by Mylan” │Associated Press – Pittsburgh │Jun. 7, 2011)

W AT S ON ’S
W

GE NE RIC L YBRE L ® RE CE IV ES F DA APPROV AL

atson Pharmaceuticals, Inc. on Jun. 7, 2011 announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for Levonorgestrel and Ethinyl Estradiol Tablets, USP, 0.09 mg/0.02 mg, the generic equivalent to Pfizer's Lybrel® tablets. Watson expects to launch the product shortly. Lybrel® had total U.S. sales of just under $12 million for the twelve months ending April 30, 2011, according to IMS Health. Lybrel® tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
For press release and other company information, visit www.watson.com

(Source: http://www.reuters.com/article/2011/06/07/idUS114727+07-Jun-2011+PRN20110607 Approval” │PR News wire – Parsippany, N.J. │Jun. 7, 2011)

│“Watsonʹs Generic Lybrel® Receives FDA

FDA GIVES FAST-TRACK STATUS TO T IOGA’S AS IMADOLINE
Federal regulators have granted special fast-track status to Tioga Pharmaceutical's
accompanied by diarrhea, the San Diego drug developer said on Jun. 1, 2011. experimental drug for treating irritable bowel syndrome

The designation will speed a review of asimadoline if the drug successfully completes late-stage clinical trials and is submitted to the agency for commercial approval. “The FDA’s granting of fast-track designation for asimadoline signals the agency recognizes that diarrhea-predominant irritable bowel syndrome is a serious illness and that patients lack a safe and effective therapy,” said Stuart Collinson, chairman and chief executive officer of the privately owned company. While the exact cause of irritable bowel syndrome is not known, researchers believe it is tied to the misfiring of the intestinal muscles. The condition often causes painful cramping, constipation and chronic diarrhea. As much as 15 percent of Americans suffer from the syndrome, according to the International Foundation for Functional Gastrointestinal Disorders. Only one drug, Lotronex, has been approve by the FDA to treat diarrhea-predominant irritable bowel syndrome. However, use of the therapy is limited to women with severe symptoms because of potentially serious side effects.
Asimadoline is a small-molecule compound, known as a kappa opioid receptor agonist, that binds with a special protein tied to muscle control. In a

Phase 2 study of asimadoline, the drug significantly reduced pain and improved intestinal muscle activity, Tioga said. Benefits from the therapy were reported through the end of the three-month test. The company launched a Phase 3 trial last June with 600 patients to further evaluate the
drug's safety and effectiveness. (Source: http://www.signonsandiego.com/news/2011/jun/02/fda-gives-fast-track-status-tioga-irritable-bowel-/ │“FDA gives fast-track status to Tioga irritable bowel drug” by Keith Darcé │Jun. 2, 2011)

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FDA APPROVALS
AUROBINDO GETS FDA APPROVAL FOR DONEPEZIL HYDROCHLORIDE TABLETS

JUNE 2011

Aurobindo Pharma Ltd. said it had received the final approval from the US FDA for its Donepezil Hydrochloride tablets 5mg and 10mg, pertaining
to ANDA No.090056. Donepezil Hydrochloride tablets 5mg and 10mg is the generic equivalent to Aricept tablets 5mg and 10mg of Eisai Medical Research Inc. Donepezil Hydrochloride tablets are indicated for the treatment of mild, moderate and severe dementia of the Alzheimer's type and fall under the Central Nervous System (CNS) therapeutic segment. The company said the product would be launched soon. As per IMS data, the product had a market size of around $2.5 billion for the twelve months ended September last year.
(Source: http://www.rttnews.com/ArticleView.aspx?Id=1636374 │“Aurobindo Pharma Gets US FDA Final Nod For Donepezil Hydrochloride Tablets” by RTT Staff Writer │Jun. 1, 2011)

FDA APPROVES OPTIMER PHARMA’S ANTIBACTERIAL DRUG DIFICID (FIDAXOMICIN)
The U.S. Food and Drug Administration (FDA) has approved Optimer Pharmaceuticals' antibacterial drug DIFICID (fidaxomicin) tablets for the
treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age and older. In the largest Phase 3 clinical studies ever conducted in CDAD, DIFICID had clinical response rates at the end of treatment that were non-inferior to oral vancomycin. DIFICID was superior to vancomycin in sustaining clinical response through 25 days beyond the end of treatment. DIFICID is the only FDAapproved antibacterial drug proven to be superior to vancomycin in sustained clinical response for CDAD. “The FDA approval of DIFICID is the culmination of Optimer’s efforts to develop an innovative therapy for the treatment of CDAD,” said Pedro Lichtinger, president and chief executive officer of Optimer. "The clinical development program for DIFICID was designed to address one of the greatest challenges in managing CDAD, disease recurrence. We are proud to provide the medical community and patients with an effective treatment proven to produce sustained clinical response in CDAD, and are now moving into the commercialization stage where we will partner with physicians and health systems to ensure that DIFICID reaches patients in urgent need of an important new treatment option. The recognition in our label of the DIFICID superiority in sustained clinical response will allow the Optimer and Cubist field force to educate the medical community about the advantage DIFICID can offer to appropriate CDAD patients." "The incidence and severity of CDAD has increased dramatically in the U.S. in the past decade and is continuing to rise each year," said Sherwood Gorbach, MD, chief scientific officer and senior vice president. " DIFICID is an important new first-line treatment option for patients who may be most at-risk of disease recurrence, for whom producing a sustained clinical response is critical. Patients who are elderly, those exposed to concomitant antibiotics and patients whose immune systems have been compromised are at increased risk, and the majority of patients who will experience a disease recurrence after their first episode of CDAD do so within the first few weeks after treatment." The approval of DIFICID was based on results from two randomized, multi-center, double-blinded trials. A non-inferiority design was utilized to demonstrate the efficacy of DIFICID (200 mg orally twice daily for 10 days) compared to vancomycin (125 mg orally four times daily for 10 days) in adults with CDAD. The studies enrolled a total of 1,164 adults with confirmed CDAD. The primary objective of both studies was to show that a 10-day course of DIFICID was as effective as oral vancomycin in achieving a clinical response at the end of therapy. An additional efficacy endpoint was sustained clinical response, defined as clinical response at the end of treatment and survival without proven or suspected CDAD recurrence through 25 days beyond the end of treatment. In the first trial, conducted in North America, 88% of patients who received DIFICID experienced a clinical response at the end of therapy compared to 86% of vancomycin-treated patients. Results for clinical response at the end of therapy were consistent in the second trial, which was conducted in North America and Europe. Sustained clinical response 25 days after the end of treatment was 70% for DIFICID-treated patients in the first trial and 72% for DIFICID-treated patients in the second trial, compared to 57% in both trials for vancomycin-treated patients.
(Source: http://www.dddmag.com/news-FDA-Approves-DIFICID-Tablets-053111.aspx │“FDA Approves DIFICID Tablets” │ Drug Discovery & Development - May 31, 2011 │Primary source: Optimer Pharmaceuticals, Inc. - www.optimerpharma.com)

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EMA NEWS
EMA AND ENCePP
PUBLISHES GUIDE ON PHARMACOEPIDEMIOLOY STANDARDS

JUNE 2011

he European Medicines Agency (EMA) and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have published guidance on methodological standards in pharmacoepidemiology – the study of the effects of drugs in large groups of people. The guidance gives reviews and access to the existing methodological guidance for research in pharmacoepidemiology and pharmacovigilance, with information on study designs and methods. These are based on internationally agreed recommendations and key points from important guidelines, published articles and textbooks. In a statement, agencies said, "The intention of the guide is not to duplicate the text from existing guidance but rather to offer the researcher a single overview document and web resource including an overview of the relevant recommendations." The ENCePP is an EMA project to strengthen the post-approval monitoring of medicinal products in Europe by facilitating studies focusing on the safety and benefit-to-risk ratio of marketed drugs. A dedicated ENCePP working group consisting of experts in pharmacoepidemiological and pharmacovigilance research developed the guide, with the final publication developed following a public consultation.

T

Please click here http://www.encepp.eu/standards_and_guidances/documents/ENCePPGuideofMethStandardsinPE.pdf to download (PDF) “Guide on
Methodological Standards in Pharmacoepidemiology”. (Source: http://www.pmlive.com/find_an_article/allarticles/categories/General/2011/june_2011/news/pharmacoepidemiology_standards_published │“Pharmacoepidemiology standards published” │Jun. 2, 2011)

BIOGEN GETS EUROPEAN OK FOR PEDIATRIC TRIAL OF HEMOPHILIA THERAPHY
Biogen Idec and Swedish Orphan Biovitrum on May 9, 2011 announced that the European Medicines Agency’s (EMA) Pediatric Committee (PDCO)
has adopted an opinion agreeing to the pediatric investigational plan for the companies’ long-lasting, fully-recombinant Factor IX Fc fusion protein
(rFIXFc).

In accordance with the PDCO’s opinion, Biogen Idec and Swedish Orphan Biovitrum plan to initiate a global pediatric trial in previously-treated patients under 12 years of age as soon as sufficient data are available from a study of older patients. Under draft guidelines published by the EMA for the development of Factor IX products, pediatric data from this trial will be required in the initial submission of a Marketing Authorization Application to the European regulatory agency. “The EMA’s agreement to our pediatric investigational plan is another milestone in our effort to develop innovative therapies for people with hemophilia,” said Glenn Pierce, M.D., Ph.D., Senior Vice President of Hemophilia at Biogen Idec. “With this opinion and the ongoing Phase 3 trials of our long-lasting Factor IX and Factor VIII programs, we continue to make progress toward our goal of improving the way hemophilia is treated worldwide.” "The opinion from the EMA’s Pediatric Committee is valuable for our promising rFIXFc project, as it allows for the development of rFIXFc in the pediatric population. We are excited about the potential of this innovative product to make a difference in the lives of people with hemophilia," said Peter Edman, Ph.D., Chief Scientific Officer of Swedish Orphan Biovitrum.
About rFIXFc and the recombinant Fc Fusion protein hemophilia program: rFIXFc is a recombinant Factor IX Fc fusion protein developed using

monomeric Fc fusion technology. The technology makes use of a natural mechanism that recycles rFIXFc in the circulation to extend its half-life. It is a fully-recombinant clotting factor designed to replace the protein that hemophilia B patients lack and to last longer in the body than commercially-available Factor IX products. rFIXFc is currently being evaluated in a registrational, open-label, multi-center trial (B-LONG) designed to evaluate its safety, pharmacokinetics and efficacy in hemophilia B patients. Using the same proprietary monomeric Fc fusion technology as rFIXFc, Biogen Idec and Swedish Orphan Biovitrum are also developing a fully-recombinant, long-lasting Factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. rFVIIIFc is currently being evaluated in a registrational, open-label, multicenter trial (A-LONG) designed to evaluate its safety, pharmacokinetics and efficacy in hemophilia A patients. For more information on the rFIXFc and rFVIIIFc trials, please visit www.biogenidechemophilia.com or www.clinicaltrials.gov
(Source: http://www.businesswire.com/news/home/20110509005600/en/Biogen-Idec-Swedish-Orphan-Biovitrum-Receive-Opinion │“Biogen Idec and Swedish Orphan Biovitrum Receive Opinion from EMA on Pediatric Plan for Long-Lasting Hemophilia B Therapy” │Weston, Mass. & Stockholm – BusinessWire │May 9, 2011)

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FUNNY PHARMA CARTOON

JUNE 2011

“ D amn the SOP’s man!!! My coffee is in there!
(Source: http://www.pharmamanufacturing.com/articles/2011/067.html │Submitted by Sean Eicher)

ANSWER

FROM T HE EXPERT

Q: What are the most vulnerable areas of the pharma supply chain, and how can I fix them?
The weak link in the pharmaceutical supply chain is education. For as much progress that has been made in recent years to educate the front end of the downstream pharmaceutical supply chain, there is still a considerable gap and lack of knowledge at the pharmacy level and “last mile” of distribution, particularly when it comes to the proper storage and distribution of time-and temperature-sensitive drugs. While everyone in the supply chain has a responsibility to the drug, it is the drug applicant or license holder (generally the manufacturer) who bears ultimate responsibility for delegating these requirements. It is therefore incumbent upon and necessary for the manufacturer to assure it has clear understanding and documented control over the entire supply chain process through the implementation of a robust quality management system (QMS). A QMS is defined by the United States Pharmacopeia as “an outline of policies, processes, and procedures that enable the identification, measurement, control, and improvement of the distribution and storage of drug products.” A critical element of a QMS is the implementation of, and adherence to, contractual agreements or service level agreements between stakeholders in the supply chain.

Kevin O’Donnell
O’Donnell is technical director for Tegrant Corporation, ThemoSafe Brands. He retired in 2005 from Abbott Laboratories as Principle Packaging Engineer with 26 years of packaging experience. (Source: “Ask The Board” │Life Science Leader – www.LifeScienceLeader.com │Feb. 2011)

C OMPAN Y PROF IL E :
A

WHO’ S WHO?

bout Pharmaceutical Solutions Industry: Pharmaceutical Solutions Industry (PSI) is the leading and the largest producer of a wide range of sterile IV & injectable solutions in the MENA region. Headquartered in Jeddah, Saudi Arabia, PSI has successfully grown to expand its portfolio catering to the needs of both domestic and worldwide markets. As one of the Arab world’s pioneering pharmaceutical companies, PSI is committed to providing healthcare market with life saving solutions. With a staff of 500 employees in addition to several full-time consultants, PSI paves its way from planning to production, for the safety, quality and efficacy of its products. PSI follows the highest standards of pharmaceutical quality assurance from planning to production. Products quality is under continuous surveillance and monitoring of highly qualified and trained personnel at each stage of the manufacturing process. Specialized in the pharmaceutical manufacturing of intravenous solutions (SVP’s and LVP’s) in different packaging forms as well as Dialysis products, PSI’s production facilities are regularly upgraded to the highest quality and safety standards requirements. With 442 worldwide registrations, PSI serves 30 countries throughout the globe. For further information, please visit www.psi.com.sa
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AGREEMENTS & COLLABORATIONS
BRISTOL-MYERS SQUIBB AND ROCHE ENTER INTO A CLINICAL COLLABORATION PACT

JUNE 2011

Bristol-Myers Squibb Company announced on Jun. 2, 2011 it has entered in to a clinical collaboration agreement with Roche to evaluate the utility
of Bristol-Myers Squibb's CTLA-4 inhibitor, YERVOY (ipilimumab), in combination with Roche's investigational oral BRAF inhibitor, vemurafenib, in treating patients with a specific type of metastatic melanoma. Under the agreement, the two companies will conduct a Phase I/II study to evaluate the safety and efficacy of the combination. If appropriate, the companies may conduct further development of the combination. This agreement represents an important cross-company collaboration exploring the potential role of this regimen in the treatment of metastatic melanoma. "Metastatic melanoma is one of the most aggressive forms of cancer," said Brian Daniels, senior vice president, Development and Medical Affairs, Bristol-Myers Squibb. "We are excited to be working with Roche to evaluate the potential that together YERVOY and vemurafenib could improve outcomes for melanoma patients."
(Source: http://www.pharmanews.eu/bms/820-bristol-myers-squibb-and-roche-enter-into-a-clinical-collaboration-agreement │“Bristol-Myers Squibb and Roche Enter into a Clinical Collaboration Agreement” │Jun. 2, 2011)

ASTRAZENECA AND HEPTARES COLLABORATE TO INVESTIGATE PRIME GPCR DRUG TARGETS
A straZeneca and Heptares Therapeutics have entered a four-year collaboration focused on the potential discovery and development of new
medicines targeting G-protein coupled receptors (GPCRs). GPCRs are among the largest and most important family of proteins found in the human body, yet they become highly unstable when removed from their natural membrane-bound environments. This instability has prevented pharmaceutical researchers from understanding GPCR structures and hampered efforts to design medicines that work on GPCR targets. This collaboration brings together Heptares' GPCR discovery expertise and proprietary technologies, including its StaR® technology, which engineers stabilized receptors allowing GPCRs to be investigated, with AstraZeneca’s biopharmaceutical discovery, development and commercial capabilities. Research conducted under the collaboration will focus on a number of specific GPCR targets linked to central nervous system/pain, cardiovascular/metabolic and inflammatory disorders from projects in AstraZeneca's small and large molecule portfolio, including projects from AstraZeneca's biologics unit, MedImmune. This research will act as the starting point for drug discovery by producing the first-ever stabilized forms of GPCRs in their natural pharmacological conformation. As part of a joint discovery effort, Heptares and AstraZeneca will engage their respective discovery teams, compound libraries, and other discovery technologies for the purposes of initial screening and lead identification. Results will be combined into a common pool and the best leads will be further optimized collaboratively. AstraZeneca will then select pre-clinical, small and large molecule candidates and will be solely responsible for preclinical and clinical development. Under the terms of the agreement, AstraZeneca has worldwide commercial rights to product candidates emerging from the collaboration. Heptares will receive an upfront $6.25 million cash payment fee plus committed research funding and also qualifies for significant future payments depending on delivery of agreed milestones. Heptares will also receive royalties on sales of all products discovered through the joint research. "This exciting collaboration gives us access to cutting-edge technology that will enable us to apply our biophysical and antibody generation capabilities to this important, yet extremely challenging, area of research. Our work will focus on a range of different diseases across our small and large molecule portfolio with the goal of discovering innovative treatments for patients in areas of medical need," said Martin Mackay, President, Research and Development, AstraZeneca. "This alliance with AstraZeneca illustrates the broad power and scalability of the Heptares technology to generate novel drug candidates in regions of GPCR space that were previously regarded as closed to pharmaceutical discovery," said Malcolm Weir, CEO of Heptares. "We look forward to working closely with our AstraZeneca colleagues to extend the range of targets and therapeutic areas to which we apply our GPCR capabilities, and are excited by the significant R&D commitment of AstraZeneca to this pioneering GPCR alliance."
(Source: http://www.pharmanews.eu/astrazeneca/818-astrazeneca-and-heptares-collaborate-to-investigate-important-gpcr-drug-targets │“AstraZeneca and Heptares collaborate to investigate important GPCR drug targets” │May 31, 2011)

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3
C
TIPS ON PACKAGING SELECTION FOR PARENTERAL PHARMA MANUFACTURERS
hoosing consistent components, mitigating the risk of recalls, and differentiation can provide competitive advantages. Enhanced regulations and regulatory guidance on current Good Manufacturing Practices (cGMP) and the trend toward biopharmaceuticals have significantly impacted drug product manufacturing. Early stage guidance from experts with experience in packaging applications and manufacturing practices can help drug manufacturers identify potential hazards associated with packaging materials while a product is still in development. By working together from an early stage, drug and packaging manufacturers can develop customized solutions that can help Mitigate risk, Increase efficiencies and Ensure sustainability while improving products and processes.

JUNE 2011

Working with a knowledgeable partner, choosing consistent components and high-quality materials, and differentiating drug product with a unique delivery or administration system can help pharmaceutical companies deliver a safe, effective product that will stand out among competitors in the marketplace.

TIP 1. CHOOSE CONSISTENT COMPONENTS. Pharmaceutical manufacturers should look for packaging components that are consistent from lot to lot. Such components will help avoid costly issues when the drug is commercialized, particularly when packaging is used consistently throughout the development lifecycle of the drug product. Use of consistent materials from R&D through commercialization enables manufacturers to determine sooner if there is any interaction between the drug and its packaging, including time-dependent issues such as glass delamination and leachables, which can affect patient safety. TIP 2. MITIGATE THE RISK OF RECALLS. As many manufacturers have learned, the choice of packaging material can impact the bottom line. By selecting container closure systems made from a novel material such as a cyclic olefin polymer companies may incur a slightly higher initial investment, but the long-term advantages can far outweigh this cost.
Offering an alternative to traditional materials, cyclic olefin polymers enable manufacturers to offer a high-quality, transparent, break-resistant material that is more inert than glass, is scratch resistant and, unlike glass, does not flake, which reduces particulate contamination within a vial or syringe system. These components also can be stored and shipped at low temperatures, which is a common requirement of many biologics.

TIP 3. DELIVER DIFFERENTIATION. How a drug product is going to be delivered should be determined based on the clinical application, and
packaging can be an important factor in getting a drug product through the regulatory approval process smoothly and to the market quickly. Initially, pharmaceutical manufacturers should seek out reliable, standardized, low-risk packaging materials, and then apply a unique administration system to differentiate and optimize delivery. Selecting a material that can be used consistently throughout the drug development process, such as a cyclic olefin polymer, can help mitigate risk and reduce time to market. Cyclic olefin polymers can be molded into a variety of shapes and sizes, enabling manufacturers to offer unique delivery or administration systems without the need to retest the material for interactions with the drug product. For pharmaceutical manufacturers, an early-stage supplier partnership can eliminate the in-house component preparation process, which can be a cost-effective method of complying with new regulations and streamlining the fill process. By creating a lasting partnership, drug makers not only help to establish compliance and improve quality, but also can rely on expert counsel throughout a drug’s lifecycle. (Source: http://www.healthcarepackaging.com/archives/2011/06/three_tips_on_packaging_select.php │“Three tips on packaging selection for parenteral pharmaceutical manufacturers” │Posted by Healthcare Packaging – Jun. 1, 2011 │Article provided by Frances L. DeGrazio, vice president, marketing and strategic business development at West Pharmaceutical Services, Inc. – www.westpharma.com)

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GS K INCREASES PRODUCTION EFFICIENCY WITH CUSTOM FILLING SYSTEM
Single-use dosing system eliminates risk of cross-contamination and speeds production
start-up time. GlaxoSmithKline (GSK) is a global research-based pharmaceutical and healthcare company committed to improving the quality of human life by enabling people to do more, feel better, and live longer. GSK’s manufacturing plant in Barnard Castle, U.K. manufactures a range of medicines including sterile liquids in vials and syringes, as well as antibiotics and topical products like Zovirax. The site also plays a key role new product launches. To support a product introduction, GSK needed a new filling solution that could eliminate cross-contamination while ensuring operational efficiency. In addition to advanced line equipment, the company required a partner to provide expertise and support services throughout the life of the project as well as to help extend its line capacity for future products.

JUNE 2011

With a long-term relationship already established, GSK turned to Bosch Packaging Technology. The two companies have partnership for years, with proven success in the installation and service of several filling lines. GSK chose to work with Bosch for its technology, support, and maintenance services. To meet GSK’s specific needs, Bosch provided a single-use dosing system with peristaltic pumps for biopharma products and for processing highly active substances. Bosch worked closely with GSK to customize a system to meet the global firm’s performance requirements. From installation through commissioning, support was provided by Bosch’s Service Team to ensure GSK’s requirements for operational efficiency and line optimization. Following and documenting a robust qualification process were also key aspects in meeting stringent pharmaceutical industry
standards, and to get the line up and running quickly. GSK project manager Graeme Wilson says: "We were very satisfied with the rapid response we received from Bosch. As a reliable service partner, they handled the design, installation, and qualification of the system successfully in a very short period of time and provided support throughout the project."

ACHIEVING EFFICIENCY
An important goal for GSK was to guarantee product safety for sensitive drugs, along with achieving efficient production. Those goals were reached through Bosch’s single-use dosing system. For GSK, the core benefit of the disposable system is the elimination of the need for cleaning and sterilizing of the product paths during batch or product changes. To further advance this technology, Bosch incorporated its PreVAS concept (PreValidated, PreAssembled, PreSterilized). Designed to enable all product-contact parts--including hoses, product bags, and filling needles--to be delivered both preassembled and sterilized, the system eliminates risk of cross-contamination and speeds production start-up. In addition, at the end of a production cycle, these parts are simply disposed of without requiring the time-consuming and costly cleaning then revalidation process. This improves efficiency while ensuring safety. The Bosch-PreVAS system also uses stainless-steel filling needles with a plastic

coating. Normally, single-use dosing systems use molded plastic needles, which allow significantly higher reproducibility of filling volumes.
The peristaltic pumps are an integral part of the PreVAS system. When integrated with a disposable filling system, peristaltic pumps offer simple operation and safety for filling of sensitive drugs and biotech products. The peristaltic pump design also enables GSK’s products to be filled with higher precision and accuracy while lengthening production cycles. Also, an offset arrangement of rollers is used where one tube is always less compressed. Stress on the tubing is decreased, reducing flow pulsations and ensuring continuous liquid flow.

"The level of dosing accuracy of the peristaltic pumps is quite impressive and we were able to prove this over various production batches,” adds Wilson.
The peristaltic pump offers quick tubing changes with only one hand. The system features a pivoting pump head cover that allows the pump to be

opened without tools and without removing the cover parts. The operator can easily open the pump to change the tubing then simply close the pump again, decreasing the set-up time. The pump also features stainless-steel housing, rotor and rollers for ease of cleaning. Continued on page 32 31

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Continued from page 31. . ‘GSK Increases Production Efficiency With Custom Filling System’

JUNE 2011

FLEXIBILITY AND SPEED-TO-MARKET
A differentiating feature is the mobility of the dosing system, which offers GSK the flexibility to use it whenever and wherever required. Mounted on a

movable trolley, the peristaltic pump acts as an autonomous filling station with a built-in control system and servo drives. This enables the pump to be positioned next to any filling line whenever required, thereby allowing GSK to extend the performance and flexibility of its filling machine.
By choosing between its current dosing system and the movable peristaltic pumps, GSK can prepare new products for production more quickly, releasing them into the market more swiftly, and with less effort. And GSK can meet its rigorous production demands without the need for an additional filling line, bringing more production capacity to the Barnard Castle site. (Source: http://www.healthcarepackaging.com/archives/2011/04/glaxosmithkline_increases_prod.php │“GlaxoSmithKline increases production efficiency with custom filling system” │Posted by Healthcare Packaging – Apr. 6, 2011 │Article supplied by Bosch Packaging Services www.boschpackagingservices.com)

M A NAG EM ENT

REVIEW : MEA SURING THE “H EA RTBEA T” OF YOUR QMS

Management Review is sometimes viewed with some ambiguity because there are so many different ways to conduct these planned sessions. Most
of the approaches taken by medical device companies to organizing these reviews are (just) compliant and even go so far as to fulfill only the very basic requirements of the Regulations (21 CFR, Part 820) and the standards (e.g. ISO 13485:2003 and ISO 9001:2000).

Being compliant and fulfilling perceived needs are not enough, however. Management Review is commonly driven by the use of various quality tools, depending upon the caliber of deliverables that are expected and the sophistication of your planned metrics.
The following article is not a primer for management review but does contain practical approaches to process orientation and communication techniques. This sometimes indescribable information relates to those subtle demands that combine your company’s Quality Management System (QMS) with business goals and objectives. You will find that Management Reviews commonly have your company’s unique signature embroidered

on the agenda, affecting the approach used to conduct a meeting of this highly visible gathering of process owners and executive management.

PREPARATION AND LOGISTICS
Management Review is a requisite requirement for compliance. Management reviewing the suitability and effectiveness of your company’s quality management system is also essential from both a regulatory standpoint and from a position of being accountable for successfully running your business operation. This is not a complicated concept. It can be tortuous if handled in an incorrect or highly politicized manner. Management Review should be a value-

added part of your operation depending upon the value of the inputs and outputs you have planned for and then appropriately realized over time. All too often companies treat this session as "just another long, meaningless meeting" where the Quality Manager conducts a half-day slide demonstration with every kind of color graph and chart, and a lunch is served at break. The quality manager is happy when the ordeal is over because it took three weeks to prepare for the extravaganza and everyone else leaves the meeting feeling rather lethargic and out of sorts with the QMS.
Where is the return on investment? Efficient and meaningful preparation and an energized approach can "make or break" this review process.

Process owners who have a defined responsibility for their process should advocate for the viability and compliance of its content and measure how effectively it is operating in terms of link-related outputs. The Quality Manager doesn't solely own Quality---everyone who participates in the
Management Review has a part to play.

COMPLIANCE AND BUSINESS INTELLIGENCE
Both the regulations and standards take a rather "broad brush" view of conducting these sessions, although ISO is much more prescriptive. It should be noted that ISO 14969 has many worthwhile suggestions for conducting these reviews. There is little mystery involved with this process of formally embracing certain key metrics and then measuring these marks of success (and failure) periodically to see if goals and objectives are being met. Continued on page 33 32

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Continued from page 32. . . . .‘Management

JUNE 2011 Review: Measuring The ‘Heartbeat’ Of Your QMS

This periodic review makes good business sense as well. If your company is not connecting "business and quality" then the executive team has truly missed the point. When this review becomes more than just redundant PowerPoint slides and starts dealing with the company’s business strategy, goals and objectives for success, the return on investment is permeated with energy and commitment. Basically, Management Reviews fail because of the lack of sincere commitment on the part of executive management. Much of the success or failure of this reporting process comes down to toplevel commitment and the use of "real" metrics linked to the core competency (s) of your company. It is as simple (and as complicated) as that!

MANAGEMENT RESPONSIBILITY AND PROCESS OWNERSHIP
Let us make this even simpler. Management Review has been aptly written into the overarching section of both ISO and the cGMPs entitled

Management Responsibility. The ultimate responsibility and care for the success (or failure) of your quality system, whether it is viewed from the world of ISO or cGMP-QSR compliance, lies with executive management. It is not just the responsibility of the quality manager or the quality
department to enable this process. Top executives at the policy and strategy decision levels of the company should ensure that the quality objectives and related business strategies are in line with the overarching quality policy. Gathering and presenting the information for these reviews is the responsibility of each individual process owner. These owners should present prescribed and purposeful metrics that demonstrate to executive management the success of each process. Compiling these indicators can "paint the big picture" concerning the health of your quality and business systems in terms of suitability, acuity, adequacy and effectiveness.

BASIC INPUTS AND OUTPUTS FROM PROCESS OWNERS
ISO is very prescriptive as to the minimal subjects to address during management review sessions. In terms of process ownership and measurement responsibility, they are as follows:
⇒ ⇒ ⇒ ⇒ ⇒ ⇒ ⇒ ⇒

The results of Quality Audits (from the Quality Audit Process Owner) Feedback from Customers (from the Regulatory Affairs and Sales Process Owners) Process Performance and Product Conformity (from the Production and Process Control Process Owner) Status of Corrective and Preventive Actions (from the CAPA Process Owner) Follow-up actions from previous review sessions (from the Management Representative) Changes that could affect the Quality Management System (from the Quality Systems Process Owner) Recommendations for Improvement (from Management Review attendees) and Reporting on new and revised regulatory requirements (from the Regulatory Affairs Process Owner)

Minimally, ISO is also prescriptive as to decisions and actions related to outputs from Management Review sessions. These include outputs involved with improvements needed to maintain the effectiveness of the Quality Management System (QMS) and improvements related to product, customer requirements and resource needs.

FREQUENCY (WHAT DOES PERIODIC MEAN?)
There is no set frequency for conducting management reviews. The famous answer starts with "at least" (X amount a year) to give you procedural flexibility. Commonly, this is a risk-based decision that is contingent upon the types and classifications of medical devices that your company produces or distributes into the marketplace, the complexity and maturity of your QMS, risk-related issues from previous management reviews, your customer base, and commitment from management to participate. For instance, an established QMS that supports the processes for Class I medical devices might require only one review per year whereas a Class II or III medical device company could commonly have upwards of four reviews per year. Best practices in this industry tend to lean toward four sessions per year to enable timely responses to trends and critical issues in a formalized fashion.

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Continued from page 32. . . . .‘Management

JUNE 2011 Review: Measuring The ‘Heartbeat’ Of Your QMS

Holding more reviews is acceptable if your QMS is still being built and has yet to mature into an effective and efficient process. Holding one Management Review per year doesn't allow for trends to be captured in a timely manner. The industry "norm" is to conduct reviews at

least four times per year to allow for the compilation of trends and to have the ability to realize the successes and failures of deliverables in a timely manner.

CONTRIBUTORS AND DELIVERABLES
Process owners representing their functional responsibilities within the QMS should come to the meeting prepared to discuss the measurements recorded since the last review and to compare that data with prior reviews. These metrics should be consistent from review to review to enable

the participants to realize trends and draw conclusions concerning corrective and preventive actions, quality improvement initiatives, areas of risk, business strategy, etc.
The Management Representative will coordinate these sessions but it is very clear, from a process architectural standpoint, that process owners should bring their results and conclusions for review and decision-making.

Outputs from these quantitative results could potentially be addressed by Corrective and/or Preventive Action initiatives and then tracked within the QMS. Simply put, Management Review deliverables can commonly initiate other actions toward resolving issues and realizing improvement.

OBJECTIVE EVIDENCE
The top-level objective evidence generated from a management review includes a procedurally-driven process, agenda points, attendance sheets, minutes and—as necessary—ensuing corrective/preventive actions. These sessions are not merely meetings with a beginning and an end (i.e., they are dynamic from review to review-to-review).

The metrics that your company decides upon commonly evolve until you reach the conclusion that these measurements are necessary to show how suitably and effectively your QMS is operating.
Every company has different expectations within the range of the necessary points to address (at least with ISO). There is not a magic or silver bullet for success. One aspect of metrics development and implementation is imperative: once your process owners have chosen viable metrics, don't change them every other review session because it will be impossible to recognize trends if the baselines keep changing. It is not that change is unacceptable but your process owners should be sensitive to trends, risk ramifications and improvements based on consistency. Find measurements that link (with a successful return on investment) to compliance as well as to business indicators and stick with them. This will add consistency to a system–based approach.

CONCLUSION
Management Reviews can be stimulating and an ongoing, rolling phase that keeps the Quality Management System healthy. Your management team can use these reviews to gauge how well the business of quality improvement and compliance is operating and plan for ongoing initiatives to enable process excellence, to produce and market medical devices that are safe and effective and to realize business success and profitability. These sessions don't have to be just another boring meeting but, in fact, can be highly energized, relevant, and indicative of management's commitment to satisfy customer requirements and enable your company to remain in compliance. Producing safe and effective medical devices should be a business goal as well as a compliance deliverable. Smart procedures, relevant metrics, serious process owners who take charge of their responsibilities and measurable outcomes are in your company's future when this process becomes part of your company culture. (Source: http://www.mastercontrol.com/newsletter/medical_device/management-review-quality-management-system.html?source=n3w5meddev% 7C70130000000XEpn │“Management Review - Measuring the "Heartbeat" of Your Quality Management System” by John Gagliardi, President of MidWest Process Innovation, LLC │ May 17, 2010)

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BALANCING
R & D P R O J E C T P O R T F O L IO S

JUNE 2011

Pharmaceutical R&D programs should represent a portfolio of projects covering a substantial range in respect to
Difficulty of Achievement, Time to Completion, and Expected Magnitude of Pay-offs (i.e., creation of a balanced portfolio) But the exploration of actual R&D portfolios from many companies reveals a heavy twisting toward short-term, low-risk projects with relatively modest expected benefits. This reflects an understandable response to the broad pressure on firms from financial markets for maintaining attractive short-term returns, which in turn encourages reliance on a net present value (NPV) capital budgeting approach toward project selection and allocation of resources. Therefore, this approach needs to be revised in favor of creating a balanced portfolio that insures that short-term business needs are met but also safeguards future competitiveness. This should be done through including longer-term, higher risk projects with a high economic potential (i.e., potential sales revenue, market franchise support, synergistic product gains, etc.) in the R&D portfolio. Often these projects have a relatively low expected NPV because of the time from market launch and/or high development cost. Companies may actively pursue their long-term opportunities preferentially over their short-term ones, or have an opposite R&D investment strategy. In either case, the companies will probably not realize the full economic value of their R&D portfolio. The key is to strike a balance between high risk/low risk and long-term/short-term projects. The exact balance of these projects for any one company, however, is dependent upon
⇒ ⇒ ⇒

Company’s risk profile Strategic Business Plan, and Company’s Overall Economic Health

Risk averse companies, or those with minimal R&D investment, will lag behind their competitors in innovation and/or market capitalization. On the other hand, companies with a very low risk aversion may be perceived as being innovative and cuttingedge, but may not be able to maintain a positive cash-flow to support a viable business.
Again a balance needs to be achieved, and that balance will be defined by each company based on What they have What they can do Their overall business environment, and Their business strategy Likewise, given a similar portfolio of projects, two companies can and probably would make very different decisions on what to pursue and what to stop or divest. Diversity of therapeutic areas, disease states, and/or discovery platforms in research and development is often regarded as a means of reducing risk. Some feel that companies, which concentrate their efforts and resources on a selected number of R&D areas, however, are more likely to achieve breakthroughs more frequently and thus manage to outstrip diversified organizations. It is believed that through focus and concentration of scarce resources coupled with cumulative knowledge the probability of success can be enhanced. This can be true, but taken to its extreme, can be equally devastating if a given line of research fails or a competitive technology hits the marketplace. Again, the issue of balance needs to be employed. Enhanced probability of successful molecule identification can be achieved through focused efforts and capacity, as long as the focused efforts do not eliminate capitalization on chance, or that through concentration of resources and direction that the organization is placed at risk from external market dynamics.

Continued on page 36 35

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Continued from page 35. . . ‘Balancing

JUNE 2011 R&D Project Portfolios’

Focusing R&D efforts can enhance organizational effectiveness through
⇒ ⇒ ⇒ ⇒

Concentration of R&D know-how Capability Knowledge, and Creation of "organizational memory"

Internal and external Competitive Intelligence (CI) can then be used To streamline research and product development To design optimized project plans To help move a product to market faster, and To contribute to a significant reduction of R&D costs

Concentrated efforts allow organizations to gather cumulative know-how, competencies, and capability from common areas. Therefore, a project portfolio focused in these areas of core competencies has a cumulative greater probability of success. Likewise, a diverse portfolio moves an organization away from its experience curve, reducing the overall aggregated probability of success and potential value. This is not meant to imply that diversification is bad, or should not be pursued, but the risks, cost, and implications of such efforts must be clearly defined and understood prior to embarking upon such a path. (Abstract from the original article: “Project Porfolio Management: A Powerful strategic weapon in Pharmaceutical Drug Development” by Tiggemann, Rolf F, Dworaczyk, David A, Sabel, Hermann │Source: Drug Information Journal │Jul-Sep 1998)

MAY

BE H A RD WO RK W ILL KIL L YOU

Those extra hours at the office had better pay off professionally, because they may be costing you years of your life.
People who work 11 hours or more a day increase their risk of heart attack or dying from heart disease by 67%, compared to people who work a standard 9-to-5, according to an April Annals of Internal Medicine report. Researchers at University College London followed 7,095 healthy civil-service employees in the United Kingdom for 12 years. Over that time, 192 of the participants suffered heart attacks. Those who worked between 10 and 11 hours a day also saw a spike in their risk of heart disease—an increase of 45%, according to U.S. News Health. “This study might make us think twice about the old adage ‘hard work won't kill you,’” Professor Stephen Holgate of the Medical Research Council, which aided with the research’s funding, told BBC News. The researchers also found that adding working hours to well-established heart risk factors (such as high-blood pressure) improved the accuracy of predictions regarding the development of coronary heart disease. In fact, the researchers believe that adding working hours to the list of heart questions general practitioners regularly ask their patients could help them identify 6,000 more of the 125,000 people who suffer heart attacks in the UK each year, according to BBC News. Despite these findings, researchers acknowledge that more studies are needed to see if a reduction in working hours actually improves heart health, as other factors could have had an effect on these results. For instance, workaholics could be experiencing high levels of stress, sacrificing exercise time, or skipping healthy meals for high-cholesterol fast food. —A.M. (Source: http://www.pm360online.com/topics_0511 │ “May be hard work will kill you”)

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MORAL DILEMMA AND THE ETHICS OF PHARMA MARKETING

JUNE 2011

You are the product manager, marketing manager, or even VP of Marketing. You understand the regulatory and legal constraints on your marketing
but are there ethical considerations depending upon how your product compares to other therapeutic options? Let us start with the easy one …. You have the treatment of choice with few, if any, other therapeutic options that can help patients for a particular indication. Any ethical issues in promoting your product? Probably not, unless you really go out of your way to exaggerate the efficacy or safety of the product beyond what you can prove. How about when your product benefit and indication is for a small patient population for which you already have a majority of the market and the company expects you to grow revenues next year? Any ethical issues now? Probably not if you continue to promote within your market but what about bigger “off-label” indications?. How about a product that is as good as everything else to treat a particular disease? Your product is no better or no worse than the other products. You might have a few features that are better but the other products have a few that are better than yours. Neither your product nor competitors has a clear efficacy, safety, or feature advantage that clinically matters.
⇒ ⇒ ⇒

What are the ethical issues for promotion in this situation? How about comparative advertising when you know there is no difference? Can you make your product look better than the other products?

This is probably the most likely scenario for most products today. Probably not too many ethical issues yet unless you exaggerate your benefits beyond your clinical proof or downplay your safety issues to create a competitive advantage. Now, same scenario as above (no difference) but you are the branded product and there are several generic versions of therapeutic alternatives (in the same class of drug) for the indication. Are you tempted to make a difference out of no difference to maintain your branded product sales? Is it ethical to expect patients (or insurers) to pay more for the same therapeutic outcome? I can hear it already…branded products are de facto better than generics. How about when you have a product that is not as effective or as safe as competitive products or therapeutic alternatives? Getting more interesting isn’t it? The company still has revenue growth expectations so what are you going to do? Should you be trying to get more patients on your product if it isn’t as safe or effective as other products? You are probably thinking it is the physician’s choice, not you making that decision….right? If you can convince the physician to use your product, it is their decision…right? How do you feel about that? How does your manager feel about this? How does your company feel about this? What would they say if you raised the issue with them? While I am not certain product managers or companies for that matter are thinking this way, they are faced with these issues everyday in the pharmaceutical industry. Think about the products your company promotes. Which scenario do each of the company’s products fit into? How are they being promoted? How do you feel about that? Anybody in the company asking these questions? What is the answer to this dilemma? How about company executives (VP Marketing or higher) recognizing the issues and making the call so as not to put front line marketing managers in a difficult, potentially career jeopardizing position? In the future, have more products in the first scenario ….innovative clearly differentiated products that you are proud of and that you can promote without having to compromise your ethics. (Source: http://www.pharmareform.com/2010/04/18/moral-dilemma-and-the-ethics-of-pharmaceutical-marketing/ │“Moral Dilemma and the Ethics of Pharmaceutical Marketing” by Mike Wokasch │Apr. 18, 2010)

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ARE YOU PHARMA SALES REP OR A PROFESSIONAL REP?
O

JUNE 2011

k, this will be a little controversial and I will probably touch a sensitive nerve or two but I am trying to help identify a way forward for the industry that will ultimately restore business viability while reestablishing trust and credibility. You also have to be thinking 3-5 years from now when you have an even more managed market where there are far more influences on physician prescribing than sales representatives. Which means representatives will have different, more analytical target audiences (think insurance company Medical Directors and their staffs, technology and product review committees, etc). If you are thinking in today’s world this may not will make no sense to you. SO HERE GOES! When it comes to skills and expertise, each of the following representative profiles has its strengths and these strengths may or may not be a good fit for a particular industry or job function. Here is how I see the two profiles:

Traditional Pharmaceutical Sales Representative:
⇒ ⇒ ⇒ ⇒ ⇒ ⇒ ⇒

Strong interpersonal and social skills help build rapport and establish relationships Exceptional selling skills and persuasive techniques Tactically oriented, relying on sales materials, promotional programs, and samples Customers are seen as prospects and a source of sales revenue Selling is seen as a competition (if I get more prescriptions I win, you lose…even if my product isn’t as good as yours) Sales numbers are a scorecard for incentive compensation Work Objective: “get the doctor to prescribe your product as much as possible”

Future Professional Representative:
Has many of the skills of the sales representative including interpersonal, social, and selling skills but… They have a patient-oriented focus around meeting or exceeding customer and market expectations (want the best product for the patient) Rely heavily on technical and scientific expertise as their base of confidence to establish rapport and build credibility and trust Sales numbers and incentive pay are not performance motivators Work Objective: “make sure patients get the right product and customers realize the maximum benefit from your products” The biggest differences between these two profiles for selling pharmaceuticals are the level of expertise and the mindset about their jobs. The professional representative goes well beyond the company training and resources to understand the science around their products and diseases. They pride themselves in staying current and knowing more about their products, the diseases being treated, and competitive products than anybody in their territories, including the physicians. They base their knowledge, presentations, and conclusions on data from the literature, which they can quote objectively and accurately. They do this because they see this not just as their job but their responsibility. The professional representative has a different motivational mindset. They are motivated more by personal performance excellence and expertise than sales numbers and incentive pay. The reason they like and do their job goes well beyond making the sale. In fact, you might even think the sale is a collateral benefit of their work. This is a very hard attribute and concept to describe because it is inherent in the thinking of a professional representative. This is one of those “you know it when you see it” type things. Their drive and motivation may not even make sense to the hard core traditional sales representative and certainly isn’t compatible with most traditional pharmaceutical sales management thinking or expectations. There is nothing wrong with being a traditional sales person. This profile drove sales in the pharmaceutical industry for decades. And, there are industries , especially retail and consumer products, that require a sales mentality to succeed. And, you can be a professional sales person, mastering the skills and acquiring the expertise related to sales of the products you are selling. But if your mindset is still that you are motivated by making the sale and the only reason for your interaction with a customer is to generate a sale, you are a sales person. The healthcare market has changed however, and one of the changes that the pharmaceutical industry must accommodate is the declining effectiveness and diminishing tolerance for the traditional sales representative role and profile. Declining physician access was perhaps the first indication of this market change. State legislation to restrict sales representative activities followed and intensified regulatory scrutiny has now made for a much more challenging environment for pharmaceutical sales representatives. As a result, I believe that a professional profile as described here is the only hope for pharmaceutical companies to have a local “in the field” presence in the evolving new healthcare market. I can hear it now….but the regulatory and legal constraints won’t allow for this profile. (Source: http://www.pharmareform.com/2010/09/15/are-you-a-pharmaceutical-sales-representative-or-a-professional-representative/ │“Are you a Pharmaceutical Sales Representative or a Professional Representative?” by Mike Wokasch │Sep. 15, 2010)

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N EW PHARMA BUSINESS MODELS: WHAT MARKETERS AND REPS NEED TO KNOW

JUNE 2011

To succeed in the new pharma landscape, marketers and reps need to learn, and unlearn, a lot. Each of us is capable of giving our best only when
facing adversities and challenges. The same happens to companies; when they face difficulties, they can best adapt and grow. If they can't, they will fade away. In Jack Welch's words: "An organization's ability to learn, and translate that learning into action rapidly, is the ultimate competitive advantage." So put your knowledge into action. Success is 90% perspiration and 10% inspiration. The new pharmaceutical business model is a big challenge for people who are working in this area. Historically, pharma firms were used to growing in double digits in Europe, but now things are changing and the growth is smaller. They are more focused consequently on BRIC countries because revenues are more promising. So that's why Europeans need to wake up. These new challenges mean not only learning in a fast way but also "unlearning"-accept it as soon as possible before it is too late. The horizon is full of opportunities, and I am going to summarize what specialists are writing and telling us about the opportunities. This is the first of a series of articles on this topic. This one is focused on marketers and commercial department people. From now on, it is critical for marketers to
⇒ ⇒ ⇒ ⇒ ⇒ ⇒ ⇒ ⇒ ⇒ ⇒ ⇒ ⇒ ⇒

Measure the ROI of the business actions Know the flow of patients, important in recession markets Tailor product messages to clients Consider new communication channels (Web, patient associations, TV) to bring you closer to the final client Lead multidisciplinary teams Use and understand new tools (iPad) Elaborate customer loyalty programs Develop treatment adherence programs for chronic diseases Design more attractive drug packaging Take into account the new compliance norms and the importance of observing them Implement closed loop marketing Know the importance of the VoM (Value of Medicine) and the impact on both health authorities and patients' quality of life Create real-world outcomes and focus on value creation.

The five key marketing imperatives will form the foundation for successful models 1. 2. 3. 4. 5. Re-center marketing on value creation within disease states Take an integrated multi-stakeholder, multi-channel approach Incorporate value creation early in the product development cycle Accelerate reallocation of marketing resources and align capabilities to support future market needs Effectively measure and manage marketing ROI

Marketers must be ready for new skills, technology, and knowledge if they want to continue playing in this new game. The faster you change the bigger part of the cake you can take. Regarding reps, it will be essential to Be certified by a university, foundation or official organization Better plan and prepare calls for each client in order to increase effectiveness Be more open-minded to new sales technologies (iPad, Web, digital) Change the role from a salesman to an advisor Understand the importance of acquiring scientific knowledge Increase compliance knowledge Understand and be ready for the e-visit Overcome the new difficulties that may arise from a continuous learning culture Acquire pharmacoeconomic knowledge & understand how it can influence positively on target clients' perception of the value of your medicine Be focused on the specific clients' needs rather than products' features, which could mean no longer being paid according to sales, but according to clients' satisfaction, based on a trusting relationships built over time. "Once access is permitted, it's imperative that sales reps nurture their relationships with physicians by remaining persistent in future calls, following up after meetings, and acting as trusted advisors and confidants," according to David Escalante Jr., president and CEO of SK&A Information Services Inc. The role of reps is changing fast and this means that some skills must be refocused and others must be either forgotten or learned. Reps can reach clients' minds if they are the first ones in giving worthwhile treatment advice that shows how their products can truly help patients and save health expenses. (Source: http://social.eyeforpharma.com/blogs/enrique-garrido/new-pharma-business-models-what-marketers-and-reps-need-know business models: What marketers and reps need to know” by Enrique Garrido, Training Manager, Grünenthal │May 31, 2011) │“New pharma

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FORECASTING THE MIDDLE EAST: AN UNCERTAIN ENVIRONMENT FOR PHARMA

JUNE 2011

Nader Rizkalla explains why, given the political turmoil in the region, forecasting the Middle Eastern market requires local business experience.
Many countries in the Middle East region are becoming more visible within the pharmaceutical corporate world as growth potential—and expectation—rise. Forecasting becomes critical and significant numbers have to be delivered. Meanwhile, forecasting takes place in a rather inflammatory environment where many major factors are unpredictable and forecasts are often not based on solid data. Here are some of the major challenges to accurate forecasting in the region.

POLITICAL TURMOIL
The area has been under a relative political stability for the past years under various suppressive regimes. With the recent popular upheavals (Tunisia, Egypt, Libya, Yemen, Syria), this stability is now over. Many countries are likely to go into a path of uncertainty, at least for some time. For example, in Egypt the passion to clear up the corruption created by the last regime might create an environment hostile to investment. Demands for better salaries and social justice will create pressure on companies to restructure based on the current realities. A couple of weeks ago, GSK—the leading pharmaceutical company in Egypt—created havoc in the market by bringing up the monthly salaries of medical representatives to the level of $1,000. This is more than double the average salaries paid for reps in Egypt. If the market follows, many companies will have to adjust their business operation models, which classically relied heavily on face-to-face promotion. Devaluation of the local currency is a threat for an industry dependent on import of either finished products or raw material. A sharp devaluation can lead to a sudden halt in the growth of the market, an incident that occurred in Egypt in 2003.

OIL
As many countries in the region are dependent on revenues from oil, a rise in price improves the economy. Countries with good oil production and a relatively big population (e.g., Algeria) have excellent growth potential. However, not all countries in the region get the benefit. Oil poor countries (e.g., Jordan, Egypt) suffer when prices go up. The challenge is to match your forecast with those cycles of oil price changes, especially given that in many countries spending on drugs is mainly out-of-pocket.

LACK OF DATA
This is classically one of the major barriers for accurate forecasting in this region. Many countries lack basic epidemiological data; some countries do not even have census data (e.g., Lebanon, for political reasons). Data on drug prescription, dispensing, and sales are often absent or grossly inaccurate. This creates big difficulties in assessing the actual potential of your market and poses a real challenge if you are trying to apply commonly used models (e.g., patient flow models).

PRICING
A wave of price reductions (between 5% and 40%) is expected in the UAE following lengthy negotiations with drugmakers. A price comparison study conducted by a committee of the Ministry of Health found that drug prices in the UAE are the highest of six neighboring Gulf Cooperation Council (GCC) and Arab states, including Bahrain, Jordan, Lebanon, Oman, and Saudi Arabia. A similar wave of reductions occurred in Egypt in 2010, with a major difference: There were no negotiations with drugmakers! These cross-regional price comparisons are becoming an issue and are leading to a spiral of price reductions. Other countries, like Egypt, have completely opaque pricing policies. It is not possible to predict what tariff price will be placed on newly launched products. It becomes a real challenge when you are placing a growth forecast based on new launches. In this environment, forecasting certainly will be based on intuition and local business experience rather than on solid scientific methodology. You have to be lean, cautious, and able to make quick changes in order to catch the opportunities and avoid the risks. (Source: http://social.eyeforpharma.com/story/forecasting-middle-east-uncertain-environment-pharma │“Forecasting the Middle East: An uncertain environment for pharma” by Nader Rizkalla, Business Unit Manager, Schering Plough │May 31, 2011)

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JUNE 2011

U PCOMING EVENT IN VIENNA, AUST RIA

2 nd ANNUAL
OPEN & COLLABORATIVE INNOVATION IN LIFE SCIENCE RESEARCH & DEVELOPMENT
Maximizing R&D Productivity & Minimizing Risk Through Efficient Management Of More Open & Competitive Collaborations & Alliances

12—13 October 2011 in Vienna, AUSTRIA E V E N T O V E R V I E W : "Open-innovation" is a concept that has been discussed a lot in recent times across many knowledge-

intensive high-tech industries, including one as innovation-dependent as the global life sciences industry. The idea of pooling risk, costs and resources, whilst hopefully increasing R&D productivity at the same time through collaborative innovation is attractive in theory, although difficult in practice in an industry when IP protection is paramount. The Human Genome Project, for example, is the greatest successful example of life science innovation and through "open" collaborative channels. Drug developers for example, are facing an acute R&D productivity crisis, with ever-decreasing numbers of molecules ever reaching the market, whilst R&D spending has been increasing rapidly at the same time. Both regulators and payers are increasingly risk-averse, and "innovation" is being redefined in terms of what the customer needs and what they're prepared to pay for. W H Y AT T E N D ?
⇒ ⇒ Understand what is meant by "open-innovation" in practice and how this can work in life sciences. Hear real-life examples of successful implementation from pharmaceutical companies, academic-led consortia, non-profits and publicprivate partnerships. ⇒ ⇒ Appreciate if the benefits outweigh the costs, as well as answers to the questions what? With who? When? Why? How? And how much? Determine how best to share information, risks and costs with R&D partners, whilst protecting intellectual property and maximizing the benefits of joint synergies. ⇒ ⇒ Find out what are the doʹs and donʹts in opening-up R&D to outsiders. Discover if "open-innovation" can truly improve R&D productivity, compared to the current model and strong tradition of R&D collaborations and alliances.

To Request the full agenda please follow the link: http://www.nextlevelpharma.com/events/ request_agenda/2nd_annual_open_collaborative_innovation_in_life_science_research_development For Booking Information Contact: Erika Vavrovicova Tel: +421 232 660 382│ Fax: +421 2 3301 0331 │ Email: [email protected] Website: www.nextlevelpharma.com

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JUNE 2011

U PCOMING CONFERENCE IN LONDON, UNIT ED KINGDOM
Organized by:

ANNUAL KEY ACCOUNT MANAGEMENT EUROPE 2011
22—23 November 2011 at Hilton, London, UNITED KINGDOM

2nd

KAM EUROPE 2011
⇒ ⇒ ⇒ ⇒ The mind-set mandate: Learn how KAM can deliver long-term, sustained profits for your business. Empower yourself and your management team to inspire, and lead, the KAM agenda from the top-down. Incentivise and compensate you workforce to reward and retain the unique qualities of your top talent. Customer centric approach: Understand where the value lies for your stakeholders, and build strong partnerships.

W H O S H O U L D AT T E N D ?
This year’s Key Account Management meeting will attract our usual high profile audience including: VPs, heads, directors and managers of: Key Account—This is the only interactive conference focused on Key Accounts—we have KAM’s presenting their case studies as well as examples from other KAMs in other industries Marketing Product/Brand Solution Providers and Consultants

I N T E R E S T E D I N S P O N S O R S HI P O P P O R T U N I T I E S ?
By sponsoring this prominent event, it will allow you to promote and enhance your brand and company portfolio through direct high profile association with eyeforpharma. Furthermore, it will give you the prime opportunity to pioneer your company as an industry leader.

We Offer
Speaking opportunities Exhibitions Workshops and interactive sessions Panels and roundtables VIP dinners Pre-event training sessions Branding opportunities, such as exposure on videos, brochures, etc. Also multiple branding opportunities within events themselves If you are interested in becoming an official partner contact Ed Harris, VP of Sales Worldwide Tel: +44 (0) 207 375 7173 │ Email: [email protected]

For More Information, Please Contact: Mr. Theo Fellgett, VP KAM EU │eyeforpharma Tel: +44 (0) 207 375 7591 Ext. 7591 │ Email: [email protected]

For more details visit online at http://www.eyeforpharma.com/kameu/index.shtml

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W HY PHARMA NEEDS TO BOOST ITS BUSINESS ACUMEN?

JUNE 2011

W ant to improve sales? Improve sales managers' business planning skills.
The pharmaceutical industry has undergone enormous change. The number of sales reps has declined significantly over the last four years. Declining sales has not only forced the industry to reduce the number of sales reps calling on physicians, but also created the need to better focus on customer needs. The days of adding sales forces are dead, and companies are struggling to find ways to deliver value to their customers. Many companies have realized that, in order to better understand and meet customer needs, they have had to evolve from a centralized/marketing focus to a customer-centric model. By moving greater decision making into the regions and territories, the ability of sales managers and sales reps to make strategic business decisions becomes even more important. With fewer reps calling on physicians, the allocation of sales calls and marketing resources must be rationalized. Have you created training programs that help your sales managers strategically look at their business? The survey says ... No. The 2011 Canadian Pharmaceutical Sales Manager Survey found that 84% of respondents felt that business planning/acumen was an important responsibility of the sales manager and 67% agreed that their organization put a high level of importance on business planning. Only 20% of respondents agreed that their organization was providing ongoing support in developing their sales managers business planning skills. Come on people, your sales managers are struggling! Can they coach their sales reps without assistance? Without training? Without support? Is a lack of business acumen within the ranks affecting your sales? Sales leaders can't ignore the issues any longer. If you want to empower your sales managers and reps to make strategic decisions, you need to adapt and align your training and development programs. It is time to find solutions. I believe that companies that build solid business planning processes that align marketing and regional sales plans with individual territory plans will have the best chance to succeed in today's competitive marketplace. (Source: http://social.eyeforpharma.com/blogs/steven-rosen/why-pharma-needs-boost-its-business-acumen │“Why pharma needs to boost its business acumen” by Steven Rosen, Sales Management Expert, Star Results – www.starresults.com │May 27, 2011)

H OW TO GET MORE VALUE FROM E XISTING PRODUCTS?

H ow to identify and support top-performing products.
Many large brands have already undergone patent expiry or are about to undergo such a change, significantly decreasing the bottom line for the companies. Of course, new brands are coming through the pipeline to replace these, but in many cases they are not being adopted with the enthusiasm of the previous products since the levels of innovation and improvement offered over their predecessors is often not considered to be significant. This means that the lost revenue from patent expired products will not necessarily be fully replaced by new blockbusters. It may not be the case for all companies, but with a significant number having fewer truly innovative drugs in the pipeline and the cost of bringing new drugs to market constantly rising (and many new drugs are failing to repay their R&D investment), the solution will come from getting every last drop of revenue from existing products. Many companies focus on life cycle strategies to do this, which are often evaluated in terms of top-line growth. However, what is also needed is an integrated holistic approach that maximizes both the growth of the existing individual products and also the lifetime profit contribution of the entire portfolio.

IMPROVING PRODUCT MANAGEMENT
To achieve this, companies must
⇒ ⇒

Improve their product management and insights in strategy, execution, and financial management and Have a clear picture of exactly what it takes to get every last drop of revenue from the entire portfolio.

Simply looking at market research data will not be enough. Simply looking at ROI of activities will not be enough. Chief marketing officers and marketing directors need to have a clear picture of the whole portfolio picture in order to make informed and profitable decisions. One way to do this is to use current market (rather than historical data-driven) predictive modeling.

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Continued from page 43. . . . ‘How To Get More Value From Existing Products?’

JUNE 2011

A study by McKinsey showed that the use of less expensive sales and marketing channels can reduce costs by 50 percent in the late phases of the lifecycle; peak sales can be reached three to nine months earlier than if these channels were not introduced. In addition, the use of predictive models like "94.8" can also show fundamental areas that are hindering growth and address these for vastly improved financial results. The financial impact gained when these improvements are applied simultaneously is substantial. However, different companies, of course, will have different results. Typically, we have seen improvements in brand sales from $50 million to as much as $500 million by implementing this approach. Taking this even further, the 94.8 approach can enlarge this analysis to the company's whole product portfolio and model the overall performance taking into account expected patent expirations and price pressures. By using this approach, the financial benefits over two years have often been seen in the range of an increase of $500 million in larger markets.

ACHIEVING MAXIMUM IMPACT
There are many avenues that can be explored when you know exactly what is having the most impact on your brands' growth rates, and where the hindrances to growth lie for both individual brands and the portfolio. It could be that the product messages need to be addressed; It could be a sales force effectiveness issue; It could be that the communication channels are not performing; It could be that the team needs to enlarge the playing field by addressing additional indications. An example of doing this well was when Bayer achieved considerable success in evolving Adalat (nifedipine) for new markets. Adalat was launched in the 1970s as an anti-anginal therapy (taken three times daily). Adalat's label was then expanded to include hypertension (with a longer acting formulation also). As a result, Adalat sales continued to grow until they exceeded $800 million a year by the early 1990s. In 1991, Bayer released a once-daily dosage form to match the emergence of competitive products with a similar duration of action. Bayer's success in identifying new indications and dosage forms, which were drivers for those markets and indications at the time, ensured that its sales continued to climb to $1.17 billion by 2000-25 years after the drug was first commercialized! Other insights could be to focus on a franchise model, or create new formulations, or even creating an RX-to-OTC switch, among many other strategies. A successful example of this was Prilosec and its evolution into Nexium, which was an OTC switch that was carried out simultaneously with the launch of the successor to the original brand. Prilosec was approved by the FDA in 1989. AstraZeneca developed a derivative, esomeprazole, which was approved by the FDA in 2001. Nexium was launched in 38 markets in 2001, and in 2003 it was the fastest-growing product in its class, with sales up 62 percent year-on-year to $38 billion. Meanwhile, the patent on Prilosec had expired in October 2001, and the company obtained FDA approval for an OTC version, which was launched under the Prilosec name in December 2002. This strategy enabled them to sell the established brand of Prilosec over the counter, while also marketing a follow-on prescription product under the Nexium brand. Smart marketing, well executed with knowledge of the drivers for the therapy areas.

UNPROFITABLE PRODUCT LINES
Other uses include knowing when to stop flogging a dead horse! Business has to be about profitability, and the process must include a means of holding a yardstick to the financial contribution of every product so that those that no longer deserve a place in the portfolio can be discontinued or sold or supported by an altered promotional mix that offers significantly greater returns. In our analytics, we have found some companies continue supporting products using traditional marketing mixes that have long ceased to be profitable and cannot be turned around. In one study, by Cap Gemini, it was found that 36% of the company's product lines were unprofitable. It also turned out that more than half the company's subsidiaries had 5+ unprofitable products. The company found that savings of 15 percent of the cost of supply operations could be achieved by dropping unprofitable product lines.

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Continued from page 44. . . . .

JUNE 2011

‘How To Get More Value From Existing Products?’

Although there is an understandable unwillingness to reduce product lines in these days of lower numbers of NMEs coming through the pipeline, the years ahead will not be kind to companies that persist in carrying unprofitable products. More robust approaches and metrics are required for understanding the real financial contribution of each product to the company is critical if companies are to identify and properly support the topperforming products of the future and reap the maximum profits possible. A holistic portfolio management analytics approach will be vital for pharmaceutical companies to develop. This needs to start early (don't consider this a ‘one off' effort, introduce a broader company portfolio approach to measurement of value), and focus on profitability throughout the lifecycle of each product and across the entire portfolio. Utilizing this type of approach will make certain that companies will get the most financial impact from their brands and achieve their portfolio's true potential. (Source: http://social.eyeforpharma.com/blogs/andree-bates/dr-bates%E2%80%99-talkback-how-get-more-value-existing-products │“Dr. Talkback: How to get more value from existing products” by Dr. Andree K. Bates, President, Eularis – www.eularis.com │May 23, 2011) Bates’

UNDERSTANDING UNCERTAINTY AND RISK IN PHARMA FORECASTING
Alec Finney, principal at Rivershill Consulting, on best practice in pharma forecasting.
The financial meltdown of 2007/8 led to a surge in the application of risk management tools not only in the most affected financial institutions but also in every aspect of investment assessment. Pharma invests heavily in new ideas, so it is not surprising to find more rigors in risk management in our industry. The ways in which forecasts are created and communicated to decision makers has also changed during this time. Forecasts now need to give some context to the single line of numbers, some expression of the certainty (or confidence) the forecaster has in the numbers. Here are some suggested guidelines on making that happen.

THE FORECASTER'S ACCOUNTABILITIES
The forecaster still has to deliver the ‘most likely forecast' based on a robust set of assumptions and using good proven models. Context to this one line forecast can be provided in two ways.
⇒

The first is to deliver an ‘envelope of possibility,' in effect a confidence interval that displays 90% of all possible outcomes, still based on the initial set of assumptions. How we generate this band is addressed below in the Monte Carlo simulations section. The second way of providing context is to describe a scenario-another significant future based on a change in a small number (usually one) of key assumptions.

⇒

LANGUAGE AND COMMUNICATION
‘Uncertainty' and ‘risk' are often used interchangeably, but they are not the same thing. We can measure uncertainty and then try to manage the underlying risk. This needs to be understood by all forecast stakeholders. For example, the technical success of a clinical trial is rated at 80%, an expression of uncertainty of an outcome. The cost of the trial might be $250 million, and it is this investment that is at risk. Also, ‘probability numbers' and ‘probability descriptions' are not consistent. Many studies show that, for example, ‘probable' is judged to be between 30% and 80%; ‘unlikely' is between 10% and 40%.Hence, there can be a possible overlap in expectation between ‘probable' and ‘unlikely'. Finally, there is a temptation to give the decision-maker as much information as possible rather than as much information as needed.

A prime example here is the ‘scenario for all seasons', a PowerPoint chart that looks like a scene from a firework display.

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Continued from page 44. . . ‘Understanding

JUNE 2011
Uncertainty & Risk In Pharma Forecasting’

RISK MANAGEMENT TOOLS
All the techniques below have utility in helping determine the level of uncertainty in a forecast, but they have limitations and have to be used carefully. Monte Carlo simulations Senior managers don't generally understand Monte Carlo simulations, which is a way of combining uncertainties. The best piece of insightful information is the Tornado Chart, where the biggest uncertainties are identified. Plans can then be made to reduce that uncertainty (at a cost) and hence reduce the risk-better conjoint, better price access studies, better epi data, for example. There is one significant danger in the use of Monte Carlo and that is recognizing when to use the dependency tool. Some assumptions are linked-price, market share, rate of uptake. The rule is to use only the prime dependencies, otherwise the link between assumptions, model, and output becomes blurred and the whole process becomes ‘black box' and people lose interest.

BLACK SCHOLES (AKA REAL OPTIONS)
Nobody really understands Black Scholes as applied to forecasts, so don't even go there. And, in a bit more detail, the basis is traded options; thus, the purchaser of a traded option is buying the upside, while not taking on the downside for the price paid. In those circumstances, volatility is a good thing and increases in volatility increase the value of the option in the Black Scholes model. In the real world, increased volatility around an investment is a bad thing, so the basis does not hold.

DECISION TREES
This is a logical step-by-step process that links options with judgmental probabilities. It is good for thinking logic through but can give a very broad range of outcomes. It is also possible for even simple decision trees to produce over 100 terminal nodes and, since the sum of all the probabilities for all the terminal nodes should add up to 100%, most have a less than 1% probability, which does not fill the decision maker with confidence about the project or help them make a decision. Again, do not show too much irrelevant data. RISK ADJUSTED NET PRESENT VALUE (RNPV) Almost the complete opposite of the above-and about as useful as the above, unless you are simply trying to produce a rank order of projectseverything is boiled down to one number. It tells you nothing about the potential of the project, or what could drive or threaten the value. Life cycle development will almost always deliver a more favorable rNPV than a new chemical entity, leading to a potentially imbalanced portfolio. In summary, forecasts can be designed to provide a risk profile around the most likely outcome. To achieve this, the forecaster needs to focus on the main uncertainties and use the risk management tools available in a simple, consistent and understandable way. (Source: http://social.eyeforpharma.com/story/understanding-uncertainty-and-risk-pharma-forecasting │“Understanding uncertainty and risk in pharma forecasting” by Alec Finney, Rivershill Consultancy │May 5, 2011)

Pharmaceutical Solutions Industry
Tel: +966 2 6361383 - Fax: 966 2 6379460 Kingdom of Saudi Arabia. For more info, visit www.psi.com.sa

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Tel: +966 2 6361383 - Fax: 966 2 6379460 P.O. Box 17476 Jeddah 21484 Kingdom of Saudi Arabia. For more info about PSI, please visit www.psi.com.sa

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