Launch Excellence in Oncology

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Adapting New Market Realities: AchievingtoLaunch Excellence in Oncology IMS ONCOLOGY LAUNCH EXCELLENCETM STUDY

 

Biotechnology phar maceutical Biotechnology and pharmaceutical companies are paying paying a high price pr ice as the Oncology Oncolo gy market market is maturing matur ing and access is increasingly restricted. Ironically, the scientific advances advances that are transforming transfor ming the treatment of cancers and the prognosis for patients are presenting new and complex commercial challenges for  marketers.

 

Adapting to New Market Realities IMS Oncology Launch Excellence Study FIGURE 1:

“Maturity,” as British playwright Tom Stoppard “Maturity,” observed, “is a high price to pay for growing up.”

GLOBAL ONCOLOGY SALES AND GROWTH

Global Oncology* Sales & Growth, 2000-2010

In a twist on this, biotechnology companies and pharmaceutical manufacturers are paying a high price pr ice as the Oncology market is maturing and access is increasingly restricted. Ironically, the scientific advances that are transforming the treatment of cancers and the prognosis for patients are presenting new and complex commercial challenges for marketers.

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25  %

   G   O   R   W T  20 H   C   O  N   S  T  15  U   .  S   .  $ 

40    N    B    $  .    S  .    U30    S    E    L    A    S

Commercial success with an Oncology launch is becoming Commercial more elusive. elusive. But it is well worth worth pursuing – pro provided vided that  you  yo u understand understand the new new “rules of the the game” game” and and the most recent strategies that have proven to work.

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A PRESSING NEED FOR ANSWERS IMS expects that Oncology will remain the top therapy area by share value in the world’s leading eight geographic markets through 2020. Thus, quite predictably, the Oncology market is of intense interest to

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2008

2009

2010

Global Oncology

Global Oncology growth

Europe Oncology growth

Global phama growth

Japan Oncology growth

U.S. Oncology growth

Source: IMS Health MIDAS MAT MAT September 2010 *Oncology defined as L1 and and L2

IMS Oncology Launch Excellence Study to identify how the key levers levers for launch success might differ from general launch preparations in other therapeutic t herapeutic areas. We set out to understand what distinguishes successful Oncology launches in the pre-launch phases by 1.) interviewing experts from within leading Oncology manufacturers and from within IMS and 2.) studying 16 leading targeted therapy launches.

both large and small s mallfranchises, R&D companies, those with existing Oncology as well as to those not yet in the field. Indeed, the industry’s collective pipeline is brimming with promise from significant innovation.

 

 Yet, all of  Yet, of this this potentia potentiall won’t won’t material materialize ize as easily easily as it has in the past. In many tumor areas, the market has evolved from one of high unmet need to one in which payers payers can afford to be “choosey” and to impose access restrictions. It is already clear that the rate of gro g rowth wth for Oncology products, while still above the global industry average, is slowing. (See Fig. 1).

IMS’s prior three launch excellence studies intentionally excluded Oncology launches because the preparation for  entering the Oncology market is much more complex and the market dynamics often radically different: Oncology is a class unto itself. With the following pages, we now give give Oncology launches their due and identify the four drivers of launch excellence in Oncology. Oncology .

In light of this moderating mo derating growth and with an eye to what the future futu re holds, IMS undertook the t he  

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DRIVER #1: PURSUE AN OPTIMAL INDICATION SEQUENCING STRATEGY

And, just as in other therapeutic areas, all of this must be evaluated within the context of the forecasted

Reaching “blockbuster” status ($1bn in annual sales) with an Oncology launch laun ch is becoming more elusive, elusive, so the first step to success is having the right indication sequencing strategy for optimal o ptimal investment and maximum return. retur n.

competitive intensity of the market and the size of the available availab le population. Once a sequencing decision has been made companies can then determine what tumor  indications are worthy of advancing into Phase III.

Since mode of actions can often be transferred between tumors, managing an Oncology agent is like a portfolio in itself. Managing multiple Oncology drugs can therefore become a daunting task. After Phase I, the available indication choices start becoming clearer as defined by the mode of action. Upon entering Phase II, companies then need to start forming for ming their sequencing strategy which includes determining:

While histor ically ically,, large patient populations wer weree the obvious first area for investment, today, one must also consider the payers' view of unmet need before selecting a path. Based on IMS research with payers, we’ve found that doing so changes the attractiveness of a number of  tumor types, as illustrated in Figures 2 and 3. In both figures, tumor types are placed in quadrants according to the number of targeted therapies available (measured   along the X axis). In Figure 2, the Y axis represents the number of available patients; in Figure 3, the payers’

•  How broad a therapeutic footprint they wish to pursue •  Whether to go for a speed-to-market or more comprehensive approach

perception of unmet need. Prostate cancer, for example, is in different quadrants in Figures 2 and 3 because while it has a large available patient population, payers perceive treatment needs to be well met.

•  What sequence of indications will work best •  How the product can be differentiated – and what clinical endpoints will be required •  The level of financial commitment needed n eeded in each scenario and whether the risk needs to be spread out

FIGURES 2 & 3:

TUMOR SEGMENTA SEGMENTATION TION

FIG 2: Tumor Segmentation by Available Population

   H    G    I    H    *    S    T    N    E    I    T    A    P    E    L    B    A    L    I    A    V    A    F    O    R    E    B    M    U    N

FIG 3: Tumor Segmentation by Payer Need

Limited alternatives and highly available population

Numerous alternatives and highly available population

Prostate Cancer

Breast Cancer

Bladder Cancer

Colorectal Cancer

Gastric Cancer

NSCLC

Limited alternatives, however, limitedly available population

Competitive landscape with limitedly available population

Melanoma

Renal Cell Carcinoma

Ovarian Cancer

   H    G    I    H

Limited alternatives and high unmet need Bladder Cancer

   D    E    E    N    T    E    M    N    U    F    O    N    O    I    T    P    E    C    R    E    P    R    E    Y    A    P

Colorectal Cancer

Ovarian Cancer

 

Melanoma

Thyroid Cancer

Limited alternatives, however, low unmet need

Competitive landscape with limited unmet needs

Prostate Cancer

Renal Cell Carcinoma

Gastric Cancer

Breast Cancer

Thyroid Cancer

Bone Metastases NSCLC

Liver    W    O    L

LOW

NUMBER OF TARGETED THERAPIES AVAILABLE

Source: *Based on Globocan prevalence

4

   W    O    L

Pancreas

 

Numerous alternatives however, unmet need remains for improved efficacy/safe efficacy/safety ty

HIGH

LOW

  NUMBER OF TARGETED THERAPIES AVAILABLE

HIGH

Source: Primary research with European payers

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A CASE IN POINT: SUCCESS IN A NICHE MARKET THROUGH A TAILORED TAILORED PHASE III PROGRAM Pfizer successfully positioned Sutent® in the renal cell carcinoma (RCC) market, in which there was high unmet need, by taking a non-traditional approach in its clinical trials. tr ials. Pfizer sponsored Phase III trials tr ials that compared   Sutent against an active comparator (rather than a placebo). The comparator was the current cur rent standard of care, interferon-a, against which Sutent showed an increased progression-free survival. In contrast, Bayer tested Nexavar ® against a placebo. Since Sutent had a strong value proposition, Pfizer employed a bold strategy, seeking, and gaining approval for  first-line therapy from the outset. ou tset. With follow-on studies, Pfizer demonstrated Sutent’s Sut ent’s superior super ior cost-effectiveness over three competitors, and rapidly became the clear market winner.  

FIGURE 4:

PATIENT EVOLUTION OF AVASTIN/SUTENT/NEXAVAR IN RCC

Patient Evolution of Avastin/Sutent/Nexavar in RCC (all stages)*

45,000 40,000 35,000    S    T    N    E    I    T    A    P    D    E    T    C    E    J    O    R    P

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C

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Nexavar Launch

Sutent Launch

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5,000 0    4    5    5    5    5    6    6    6    6    7    7    7    7    8    8    8    8    9    9    9    0    0    0    0    0    0    0    0    0    0    0    0    0    0    0    0    0    0    0    0    4    1    2    3    4    1    2    3    4    1    2    3    4    1    2    3    4    1    2    3    Q    Q    Q    Q    Q    Q    Q    Q    Q    Q    Q    Q    Q    Q    Q    Q    Q    Q    Q    Q

Avastin

 – FDA FDA approves approves A. February 2007 2007 – Sutent in first line based on Phase III trial results demonstrating increased progression-free survival (PFS)

Sutent

 – At American Society B. June 2008 2008 – of Clinical Oncology (ASCO), Pfizer presents Phase III results, comparing Sutent with interferon alpha in untreated metastatic renal cell carcinoma (mRCC) patients, demonstrating overall survival (OS) of more than two years for the first

Nexavar

 – Pfizer presents a C. September 2008 2008 – cost-effectiveness trial comparing Sutent with Nexavar, Torisel® and Avastin®. Results Results show Sutent Sute nt is more cost-effective in first line and provides better overall quality of life

time in mRCC Source: IMS Oncology Analyzer TM (MAT QTRs) and IMS Knowledge link *Market includes U.S., EU5, Japan, Korea, Korea, China and Taiwan

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Optimizing Clinical Trials The next hurdle will be to ensure that the right

DRIVER #2: MAKE THE RIGHT SEGMENTATION TRADE-OFFS

endpoints are built into the clinical tr ial plan. The clinical trial endpoints that will hold swa sway y with payers depend upon payer perceptions perceptions of the unmet need and the number of targeted therapies available to treat a tumor  type. One common thread is that pay payers ers want to see significant improvement in survival; however the definition of the word "significant" changes by tumor  type. Today oday,, payers payers regard response res ponse rate and time to progression as insufficient surrogate endpoints on which to base their reimbursement decisions.

types, one viable strategy that is gaining ground g round is to limit one’s market to a sub-group of patients for whom the product produces a greater response rate and hopefully, also higher overall survival rate. Using biomarkers to segment the patient pool in this way, of  course, means sacrificing a larger patient population for a stronger value proposition that translates into market access and, potentially, premium pricing. Bear in mind, though, that the alternative, aiming for a larger  population, could fail to t o produce the necessary clinical endpoints and thus preclude you from from gaining any market access.

Overall Survival Measures of patients’ OS time g iv ives es payers the best grasp of a product’s value. Increasingly, payers require a demonstration of increased overall survival time, and it may be difficult to present a compelling health economic argument without it. So, what increase in survival time t ime is sufficient? To achieve achi eve clear differentiation, particularly for tumor types where treatment alternatives exist, an increase of more than six months may be necessary; in areas of high unmet need, an increase of two-to-four months may be acceptable. Progression-Free Survival PFS statistics are usually considered surrogate endpoints for overall survival and are most acceptable for early-line therapies (payers expect companies to provide overall overall survival data at a later stage). Their acceptability, however, depends on the th e environment. In the EU and Japan, products supported only by PFS data may face access barriers, while in the U.S., they will likely be covered by payers.

Given Giv en how restrictive the market now is for some tumor 

A strong value proposition, hence (easy) market access, will greatly enhance further indication approvals and possibly result in premium price reimbursement. The positive acceptance among the medical community will then rebalance the initial limitation of economic potential due to patient stratification. Therefore, in some tumor types, developing a biomarker  early in the dev development elopment cycle is a desirable priority, albeit a difficult one. One company representative likened developing developing a biomarker to developing another  product, meaning that the process is that complex and also adds considerably to the ov overall erall cost of development. Advice from our interviewees on biomarkers includes: •  Examine the trends in physicians’ use of biomarkers in the selected market •  Think through how you can ensure correct use of the biomarker and make sure that it is practical and an d easy for  physicians to adopt •  Consider the cost of the biomarker and who will pay for it •  Decide who will dev develop elop the biomarker (Can it be done in house, or should you partner with a diagnostics specialist?) •  Aim to have a biomarker as a competitiv competitivee advantage against an existing “gold standard” treatment •  Consider foregoing a biomarker if the unmet need is high

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A CASE IN POINT: THE VALUE OF A BIOMARKER IN THE COLORECTAL CANCER MARKET Amgen was the first company to show the use of Kirsten Rat Sarcoma (KRAS) mutation as a predicti predictive ve biomarker  biomarker  for Epidermal Growth Factor Receptor (EGFR) metastatic colorectal cancer (CRC) and received approval in the EU for the use of Vectibix® in patients with EGFR+ KRAS wild type ty pe CRC. The product was launched earlier in the U.S. without the benefit of a biomarker for EGFR+ patients, at a 20 percent discount over Erbitux®, which was already on the market. ImClone/Merck Serono then followed with its own KRAS studies for Erbitux, confirming Amgen’s findings. In late 2008, both companies asked the U.S. Food and Drug Administration (FDA) (FDA) to change their original orig inal labeling to limit the indication to KRAS wild type patients. Both products now are approved for the same type of patient population. Now, within this segment of patients, Erbitux has captured much more of the market than Avastin as second-line therapy,, and both Erbitux and Vectibix outperfor therapy outperform m Avastin as third-line therapy (IMS Oncology Analyzer ™). FIGURE 5:

DRIVER #3: EMPLOY NOVEL APPROACHES TO GAIN PAYER DRIVER ACCEPTANCE ACC EPTANCE Even companies companies that have adopted successful lifecycle and segmentation strategies can meet with with resistance from payers on their Oncology products. Universally, payers pay ers are struggling to find the balance between their  desire to maintain access for patients and their need to control costs. costs. On the one hand, they face political sensitivity and public pressure to make make Oncology  Oncology treatments available and they acquiesce. On the other  hand, their budgets are constrained and must cov cover er other  therapy areas as well. The cost pressure is mounting for several reasons: the incidence incid ence of cancer is increasing, targeted therapies are expensive, and in some tumor s, s, treatment is shifting from acute to more chronic care. Payers, therefore Payers, therefore,, employ a variety of tools too ls – some quite inventiv inv entivee – to control pricing and market access and shift the risk to manufacturers. manufacturers. Payers in Europe have certainly become pioneers in this arena; toda  y, the EU is  y, one of the harshest payer environments for Oncology, both at a national and regional region al level. Figure 5 is a snapshot of management techniques used in the top-five European markets.

EVOLVING ACCESS BARRIERS IN EU

Evolving Access Barriers in EU

EVOLVING LANDSCAPE

ASMR ratings expected to become more challenging Extra-T2A budget cap and hospital payback scheme are increasing budget sensitivity at hospital level Stricter Authorisation Temporaire d’Utilisation (ATU) (early marketing marketin g authorization) eligibility criteria criter ia

4 = In Place

P  r  i    c   e 

Market access challenges now expected for all products

IMS HEALTH

ONCOLOGY MANAGEMENT   c  F  r   c  a  R   g P   e  R  h  u  o g i    u r   s  e   e   s   a  n n r  i    g   t   k   e   d   s   l    d  i    t  r   l   r  e  s   e  c   o i    e i    a  r   c  m n  l   n n h   c  i  i    t   o i    l    t  i   r   e  n b  i    e  g   g  n a  n n e   e  n a   s  g   g  t   s   s   / 



Funding at regional level becoming becoming a challenge Cost-effectiveness analyses, etc.



A T  H   s  e   e   s  c   e h  a   t   s  n l    s  o h  m  e  l    o n g   t  y   s 

4 4

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Regional differences in access are becoming the norm

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Increasing requir ement for proof-o proof-of-performance f-performance data and promotion promo tionrequirement of non-pharmaceutical treatments

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F  = Future Impact

F  4

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Consequently, a product that is systematically reviewed across Europe can easily receive different outcomes from

At first glance, the dramatic lift in sales that products in the UK experienced (See Fig. 6) after entering into a

the clinical cl inical data analysis. Bayer’s Nexavar, for example, exa mple, was recommended for coverage in France, Poland, Poland, Sweden, and the Netherlands (the latter with limitations), but denied in Denmark and the UK. What is more, the outcomes of the economic reviews by the assessors were more disparate still. Companies clearly need to prepare their dossiers to address the requirements and perspectives of individual countries. countr ies. Each will have have its own idea of  what constitutes good value for the money.

risk-sharing agreement might suggest that the agreements were advantageous to the manufacturers in boosting sales. In reality, they simply made sales possible. In other words, the agreements gave products access that they would not otherwise have been granted. As one member of the industry industr y commented, “If we we didn’t enter  into the risk-shar risk-sharing ing scheme, we wouldn’t really have have a market here.’’

Trends in Risk Sharing For some companies, getting over the hurdles that payers construct has meant a further sacrifice through the use of  risk-sharing risk-shar ing agreements, ag reements, whereby the manufacturer  makes concessions if certain performance perfor mance levels are not met or whereby the manufacturer limits the pay payers’ ers’ financial exposure. Risk-sharing agreements will continue to gain momentum, particularly in Europe, where the trend will be to follow the lead of Italy and the UK, the region’s most restrictive markets. In Italy, risk-sharing agreements have been mandated since 2007, and in the UK, risksharing ag reements have have been employed in a number of  launches. (See Fig. 6)

 

FIGURE 6:

DIFFERENCE IN YEARLY SALES

Yearly sales 12 months prior to scheme

76%

Yearly sales 12 months post-scheme

40

Increase in yearly sales

259%

35    )    N    B    $  .    S  .    U    (    S    E    L    A    S    Y    L    R    A    E    Y

There appears to be no avoiding avoiding it – companies bringing new Oncology products to market need to be prepare prepared d to share some of the risk r isk that payers bear, particularly in Europe.. This rather harsh reality begs the question – does Europe sharing the risk, as payers are now demanding, render a launch in certain countries so unprofitable that they should be ov overlooked? erlooked? Are some markets inconsequential enough, once the r isk is shared, that they should be excluded from a global launch? Is this ethically and practically possible? The U.S. Payer Payer Landscape Landsca pe In the U.S., the nature of the payer landscape, given that it’s being drive dr iven n mostly by private insurers, means that

Difference in Yearly Sales in UK, 12 Months Post Risk-Sharing Agreement

45

We foresee that while r isk-sharing will become more commonplace, the nature of the schemes will shift. Payers are eschewing schemes that require measuring patient response in favor of financial arrangements that amount to an upfront discount. These arrangements ar rangements are much easier for all concerned to t o manage.

companies are faced with different challenges than in Europe.. Market Europe Market access restrictions have traditionally been less stringent than in Europe and ‘off-label’ use can often be reimbursed if there is a substantial subst antial body of evidence (compendia listed).

164%

30

59%

25 20 15

71%

10 5 0 SUTENT

REVLIMID®

VELCADE®

TARCEVA®

ERBITUX

However, commercial payer reviews have now become more cumbersome and private doctors’ offices are faced with highly bureaucratic processes, especially around submission of prior authorizations (PAs) for the use of  oncologics in an on- or off-label setting. As a result, private office support in navigating this PA landscape has become an important part of a pharmaceutical company’s approach to ov overcoming ercoming payer restrictions in the U.S..

Source: IMS Health MIDAS September 2010. Sales include all indications.

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IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

 

 

Out-of-pocket costs in the U.S. can also be a significant hurdle for about 20% of o f the patients, which can

DRIVER #4: BUILD A STRONG ONCOLOGY FRANCHISE

ultimately lead to a small percentage of overall patients (2-5%) changing either treatment setting or therapy. therapy. Product formulation is also a challenge as there are significant differences in reimbursement between orals and IVs, which can also limit product adoption. Once again, the support of phar maceutical companies in running patient assistance programs, as well as early access programs, is a powerful tool in enabling patient access to treatment.

studied was the sponsor companies' investment investment in achieving a degree of prominence in the therapy area. They had had – or were were focused focused on gaining gaining – a durable durable Oncology franchise. By this, we mean that they:

Looking out into the future, the U.S. payer landscape is slowly following the footsteps of Europe and the arrival of U.S. U.S. healthcare reform will also contr ibute to that trend.

•  Established a reputation as a leading player in the field (which is perhaps more difficult in Oncology because oncologists themselves are so specialized that they may not see the breadth of what a company offers)

Pa Payer management is likelynumbers to become morewith restrictive foryer oncologics (increasing of PAs) an increased emphasis on comparativ comparativee effectiveness and cost-shifting to patients. For pharmaceutical companies, this translates into more head-to-head trials and an increasing focus on biomarkers and demonstrating overall cost-effectiveness.

FIGURE 7:

Another commonality among the successful launches we

•  Demonstrated a long-term commitment to Oncology •  Pursued ambitious goals •  Developed treatments across across tumor types via multiple products/indications

This, in turn, gave them enviable access to key opinion leaders (KOLs), prescribers, and patients for clinical trials. Interestingly, few companies have gained such a presence;  just three companies hold more than half of the value of  the Oncology market. (See Fig. 7) Companies intending to enter the market face formidable for midable competition from these market leaders and must aim to achieve their own “critical mass” mass ” in the market.

TOP GLOBAL ONCOLOGY FRANCHISES Top Global Oncology Franchises Franchises Share of Sales* Sales* (Global sales = $47.2bn) 17%

(Year of Launch) Avastin Mabthera® 2% 35%

2%

Roche

2%

(2004)

(1997)

Herceptin®

Tarceva®

(1998)

(2004)

3% 4%

Novartis

Glivec® (2001)

Tasigna® Afinitor® (2007)

(2009)

8%

11%

8%

AstraZeneca

8%

IMS HEALTH

Roche

Novartis

AstraZeneca

Lilly

Sanofi

Pfizer

Takeda

MSD

BMS

J&J

All others

Arimidex®

Zoladex®

(1995)

(1987)

Casodex®

Iressa®

(1995)

(2002)

Source: IMS MIDAS MAT September 2010 *Oncology defined as L1+L2 and limited to ethical, non-generic  non-generic 

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However, with attention to the right factors (See Fig. 8), companies can break into the market and, over time, establish leading franchise. Companies intending toastrengthen their Oncology franchises must be mindful of o f these conditions: • KOLs are themselves, customers. Given Given the small pool of oncologists, thought leaders in the field are more than usually influential, and engaging them in clinical trial design and expanded access programs is critical • While payers payers are an important audience, their  influence over prescribing decisions in Oncology has not ov overshadow ershadowed ed that of physicians, as it has in other therapeutic areas

FIGURE 8:

• Gaining access to physicians requires requires having having the “right” talent and mix of medical and business skills on board. Increasingly Increasin gly,, physicians prefer  speaking with medical liaisons, given their deeper  understanding of the t he science inv involved. olved. As one o ne person we interviewed explained, “It’s hard [for  sales people] to get into the Oncology scene and understand the core dynamics” • Raising public awareness awareness and inspiring brand advocacy is crucially important. Involv Involvement ement of  society beyond patient support groups and use of a battery of media outlets should s hould become standard operating procedure.The future of Oncology lies at a conceptual, rather than at a drug level; concept not just ‘pill’

KEY SUCCESS FACTORS

Key Success Factors for an Oncology Franchise

VERBATIMS* SUB-NATIONAL 1

KOL MANAGEMENT 

BALANCE 2

TALENTS & ORGANIZATION

ESTABLISH 3

SOCIAL PUBLIC RELATIONS

• Small pool of oncologists and key thought leaders remain an influential, but increasingly selective, ‘customer’ • Engagement at local lev level el via clinical trial tr ial design cooperation and expanded access programs are key success factors

‘‘For a small company like us, with little experience in Oncology, the focus was on creating goodwill with physicians ’’

• Importance of attracting the ‘right’ Oncology-specific talent (e.g. medics for  clinical development and medical liaisons)

‘‘It’s hard to get into the Oncology scene and understand the core

and balance with management skillsstate-of-the-art

• Active involvement of patients and comprehensive use of media channels is crucial in order to help raise social awareness and ‘push’ brand advocacy

dynamics’’

‘‘More effort should have been spent on patient support g roups and incorporation of their  recommendations’’

NEW GO-TO-MARKET MODEL

ellence interviews Source: *IMS Oncology Launch Exc ellence

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Case Study A CASE IN POINT: NOVARTIS BUILDS A WORLD-RENOWNED FRANCHISE OVER A DECADE Novartis, now the second largest player in the global Oncology market, was a newcomer to Oncology when it launched Gliv Glivec ec as first-line treatment t reatment for  chronic myeloid leukemia (CML) in 2000. How’d they do it? Through a number of bold strategic mov moves es and absolute commitment that made the most of  Glivec’s Gliv ec’s potential • The company, company, with the help of a noted no ted oncologist/ researcher, established CML as the key indication for  Glivec, even though CML is a rare disease and had received receiv ed limited medical attention (an example of  the niche market/high unmet need discussed above) above) • Novartis Novartis took the unusual step of altering the formulation (from continuous infusion to oral) while Glivec was in Phase I. This addressed patient concerns and raised the value proposition of the drug • To aid clinical trial enrollment, Nov Novartis artis convinced key cancer centers in the U.S. to participate in the first CML Phase I clinical trials and used the Internet (a new social medium at the time) to involve inv olve patient support groups

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• The company published Phase I results results for Glivec Glivec and generated an ava avalanche lanche of o f public interest. With all of this media coverage, Glivec was a success before it even launched • In 2000, Nov Novartis artis set up an expanded access program, enrolling 7,000 patients in 32 countries. The product, on the FDA Fast Track list, was given accelerated approval approval and priority pr iority revie review w • Novartis Novartis sought other indications for Glivec, Glivec, including the treatment of gastrointestinal tumors • The company then tailored its commercial commercial model to accommodate Tasigna, another treatment for CML. Initially, Novartis launched Tasigna as second-line treatment, so that it did not no t cannibalize Glivec sales. But with Glivec's patent expiration looming, Novartis Nov artis began preparing Tasigna Tasigna to become the new standard of care care.. The results of a head-to-head trial with Glivec proved Tasigna’s superiority, and Tasigna was approved as first-line treatment for  newly diagnosed patients. Novartis is now undertaking multiple clinical trials to determine how best to switch patients from Glivec to Tasigna

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Conclusion Companies with a strategic focus on Oncology must accept the fact that the market has changed, with many tumors maturing and payers using new criteria to evaluate treatments. Success in Oncology requires new levels lev els of both clinical leadership and commercial savvy. savvy. From our observation, discussions, and analysis, we’ve determined that the most successful Oncology launches all share the following characteristics: • An investment investment strategy that maximizes maximizes returns using the best entry entr y route and carefully considered indication sequencing • A strategy for developing developing a patient profile that makes makes the right r ight trade-offs between the benefits/drawbacks benefits/drawbacks of  targeting large patient populations versus sub-segments, which will drive the increasing need for biomarkers • A realistic understanding of what pay payers ers in different countries are prepared to pay for and a flexible approach to meeting their criteria to maximize the possible access by country

To enjoy the combined benefit of all four success factors, companies have to appreciate the unique timelines of  preparation – both pre- and post-launch and must begin working on the first three of these goals as early as Phase II. A successful Oncology launch requires companies to make more major investment decisions, earlier, and in a highly fluid and uncertain environment; a highly effective scenario evaluation and risk management strategy is absolutely essential. Companies also need to be more attuned to a country’s Oncology stakeholders than ever before, before, and to have a customer-facing custom er-facing organization organ ization with strong cross-functional integration to ensure a completely holistic approach to stakeholder  management. Over Over time, mastering these areas will help develop a public image as a leader in Oncology but the  journey is is not ove over. r. Compani Companies es must must remember remember that maintaining that reputation requires continual “maintenance” even post-launch.

• The positive positive “halo” that emanates from from being part of  an established and well-r well-regarded egarded Oncology franchise

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IMS HEALTH

IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

 

Appendix THE STUDY APPROACH The IMS Oncology Launch Excellence Study combines both quantitative and qualitative findings. We analyzed the launch approaches and market results of 16 of the most influential launches for targeted therapies across 10 countr c ountries ies (U.S (U.S., ., Japan, Germany, Germany, France, China, Italy, Spain, UK, Korea,Taiwan), observing observ ing what has worked and what hasn’t hasn’t.. The quantitative findings reflect sales results reported in IMS MIDASTM and from IMS Oncology Onco logy Analyzer, which presents patient numbers and brand penetration by tumor type, disease stage, and line of o f therapy. therapy. The qualitative conclusions are drawn from interviews conducted with senior executives in R&D companies and within IMS. All have extensive experience in Oncology and were forthright in offering their views. The IMS Oncology Launch Excellence Study analyzed launch approaches and market results for the following products:

• Avastin

• Iressa®

• Sprycel®

• Tykerb®

• Erbitux

• Mabthera

• Sutent

• Vectibix

• Glivec

• Nexavar 

• Tarceva

• Velcade

• Herceptin

• Revlimid

• Tasigna

•  Y  Yondelis ondelis®

IMS HEALTH

IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

13

 

IMS Specialty Solutions

TM

Our Oncology offerings are part of IMS Specialty Solutions - a portfolio of next-generation market

With a full continuum of information assets, analytics and consulting services, ser vices, IMS Specialty Solutions empow empowers ers

intelligence all focused exclusively on specialty markets.

clients to make more confident, evidence-based evidence-based commercial decisions, faster and with greater efficiency.

IMS Capabilities in Launch Excellence Our proven framework – leveraged successfully with more than 50 launch teams – ensures best-in-class diagnostics, planning and tracking for optimal launch

With an offering built on deep functional knowledge and expertise in more than 90 therapy areas, we combine the skills and experience of 1,700 IMS consultants across the

performance.

launch spectrum, to drive best practice launch execution and internal change management for our clients.

About the Authors DR. WOLFRAM LUX

NIKOLAOS KONTOS

Principal, Management Consulting, IMS Health Wolfram is focusing on Launch Excellence projects on a global scale. Being a molecular biologist and chemist by training Wolfram started star ted his career as a management consultant focusing on in-licensing and risk management. He then joined Schering’s Oncology business before joining the IMS Management Consulting team in 2007 where he led the European Oncology Business Unit from 2009.

Consultant, Thought Leadership, IMS Health Nikolaos is a consultant on the th e Thought Leadership team, responsible for creating industry viewpoints on a wide range of issues and therapy areas. In his role, Nick has worked on a variety of initiatives primarily in specialist areas and with a particular focus on Oncology. Nick holds a Masters degree in Biochemical Engineering from University Unive rsity College London, in the UK.

14

IMS HEALTH

IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

 

Companies with a strategic focus on Oncology Oncolo gy must accept the fact that the market has changed, with many tumors maturing and payers using new criteria to evaluate ev aluate treatments. Succes Successs in Oncology requires new levels of both clinical leader lead ership ship and comm commercial ercial savvy savvy..

 

ABOUT IMS

IMS Health is the leading provider of information services for the healthcare industry around the world.The company draws on its global technology infrastructure and unique combination of in-depth, sophisticated analytics, on-shore and off-shore commercial services, and consulting platforms to help clients better understand the performance and value of medicines. With a presence in 100+ countries and more than 55 years of industry experience, IMS Health serves leading decision makers in healthcare, including pharmaceutical manufacturers and distributors, providers,

IMS HEALTH®

CORPORATEE HEADQUARTERS CORPORAT IMS Health 901 Main Avenue, Suite 612 Norwalk, CT 06851–1187 USA Tel: 203.845.5200 www.imshealth.com

payers, government agencies, policymakers, researchers and the financial community. Additional information is available at http://www http://www.imshealth.com. .imshealth.com.

©2011 IMS Health Incorporated or its affiliates. All Rights Reserved.

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