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Weight Loss Research and Results and Commentary on Three Pipeline Drugs

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  • 1. Ipsos*Vantis Weight Loss ResearchResults and Commentary on Three Pipeline DrugsLorcaserin | Qnexa | Contrave © 2010 Ipsos• [name of the entity issuing the document]. All rights reserved. Contains Ipsos Confidential andDecember 9, 2010 Proprietary information and may not be disclosed or reproduced without the prior written consent of Ipsos. Nobody’s Unpredictable
  • 2. Obesity Analytical Group Tom Young- Vice President, Healthcare Office: 973.658.1686 Mobile: 201.755.6096 tom.young@ipsos.com Bob Shekhdar - Senior Consultant Office: 203.329.8756 Mobile: 203.559.7620 bob.shekhdar@ipsos.com Month Day, Year 2© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 2
  • 3. Disclaimer The following presentation has been prepared by analysts at Ipsos Vantis. The information contained herein is based on research data collected by Ipsos Vantis and other secondary, non-company affiliated sources and is believed, but not guaranteed, to be accurate. The presentation is for informational purposes only and nothing in this presentation constitutes a representation of the accuracy of any forecast or market prediction, nor does it recommend taking any action in regard to the public companies named in the presentation. No representation or warranty, either express or implied, is provided in relation to the accuracy, completeness or reliability of the information contained herein nor is it intended to be a complete statement or summary of the companies, markets or drug developments referred to in the presentation. The analysis contained herein is based on numerous assumptions. Different assumptions could result in materially different results. Month Day, Year 3© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 3
  • 4. Ipsos Overview Ipsos-Vantis Ipsos-Novaction Forecasting, modeling and consulting for Rx Forecasting, modeling and consulting for drugs, B2B medical devices and personal FMCG & OTC drugs health care – as well as durable products, services & non-medical B2B Health Ipsos-ASI Qualitative & Quantitative research for Advertising testing and brand health Pharmaceutical industry Ipsos-Public Affairs Public opinion Month Day, Year 4© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 4
  • 5. About Ipsos*Vantis  Vantis Health is a group of specialists who predict the business impact of marketing decisions and market events  We reliably link research results to ROI to help clients make the right strategic and tactical decisions  …on a global basis and in the context of changing market conditions  Vantis originated with BASES for the purpose of extending CPG models  Categories  Target audience  Marketing channels (direct, medical, Internet etc)  Influencers (medical professionals, patients on professionals)  Product, pricing and positioning optimization, as well as marketing plan simulation Month Day, Year 5© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 5
  • 6. Setting the Stage Month Day, Year 6© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 6
  • 7. “Corpulence is not only a disease itself, but the harbinger of others” … Hippocrates  Pharmaceutical companies have made efforts to develop Rx meds for weight loss, but with such limited success then with Meridia’s withdrawal this year, only Xenical remains on the market as an approved drug for long- term use.  The current market is dominated by generic phentermine, approved only for short-term use, and is a controlled substance.  Doctors are enthusiastic about the pipeline medications, but frustrated that they currently have so few options.  Bariatric surgery – currently popular and very effective, but expensive, demonized by payors, and only a solution for a very slim group of obese patients  OTC Meds (alli – low dose Xenical)  Diet and Exercise - great advice, outcomes good when followed, seldom followed  Liposuction Month Day, Year 7© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 7
  • 8. Timeline: FDA and Weight Loss Drugs J&J tests topiramate, an Vivus submits NDA epilepsy / migraine headache Pfizer and Merck in for Qnexa Pharma Companies drug, in weight loss trials clinical trials to Sanofi-Aventis develop CB-1 withdraws Zimulti Orexigen blockers (rimonabant) NDA NDA for Antidepressant Wellbutrin Contrave (buproprion), in weight loss clinical trials. J&J discontinues Arena Topomax (topiramate) Merck, Abbott Pfizer stop NDA for weight-loss trials withdraws CB-1 trials lorcaserin Meridia 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 FDA gives OTC approval Advisory Panel vote splits FDA forms Obesity for low-dose orlistat (alli) 5-5 on Meridia withdrawal Task Force FDA says lorcaserin FDA asks Abbott to and Qnexa “Not FDA FDA rejects Zimulti withdraw Meridia approvable in (rimonabant) NDA due to (sibrutamine) from present form” psychological side effects US market FDA 12/7 Advisory Committee voted for approval of Contrave Month Day, Year 8© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 8
  • 9. Wall Street Opinion on Weight Loss Drug Market “Obesity is an epidemic; mortality escalates with weight; the cost-effectiveness argument is “We see a significant market opportunity in easy; the market is enormous. Hence, no one obesity, although this remains controversial argues a good drug would not be a mega- among investors. We believe the lack of blockbuster. The FDA remains a formidable historical commercial success for obesity hurdle.” Jefferies and Company, 2/10 drugs has been a function of poor efficacy and intolerable side effects, both of which can be addressed by lorcaserins profile.” “We believe Qnexa would satisfy a significant Jefferies and Company, 12/09 unmet need -- an extremely effective weight loss medication that does not require behavior modification.” Jessup & Lamont 2/2010 “The FDA is highly unlikely to approve Qnexa on the heels of the Meridia withdrawal without requesting a thorough cardiovascular safety “While our view that lorcaserin may have the trial for Qnexa.” best shot at approval among the late-stage Cowen & Company, 10/10 obesity drug candidates – as we described following the Qnexa panel – is unchanged, we are no longer comfortable with the near-term risk/reward. As such, we are downgrading ARNA to Neutral.” JP Morgan 8/10 Month Day, Year 9© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 9
  • 10. Understanding the obesity market from multiple viewpoints Month Day, 10 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 10
  • 11. One Concern – Is the FDA “out-of-sync?”Stakeholder Quick Facts/Evidence Enthusiasm for New Rx MedsPatients/Society  74% of Americans are overweight or obese (Forbes, 2007) High  The WHO says that obesity will eclipse undernutrition and infectious disease as the number one world health problemPhysicians  The focus of this presentation – extremely enthusiastic about Very High having something to offer obese patientsDrug Manufacturers  Many large companies have de-emphasized weight loss, with High/Varied pipelines oriented around cancer, biologicals, CNS and other drugs that have a high unit cost.The Investment  Generally aware of massive patient size, but analysts tend to be VariedCommunity very enthusiastic, or at the opposite extremeManaged Care  We suspect that pharmacoeconomic benefit will eventually sway Moderate payors in favor of these drugs, but patient volume suggests that getting on formulary will be an uphill battle initially.Other businesses  No worries for this group. These medications are all taken as part Medium-Hightaking part in the of regimens, which always include diet and exercise. In fact, we$150 Billion Weight note that structured diet program participants are very likely toLoss Industry take prescription pharmaceuticals.The FDA/Regulatory  FDA action of this week was surprising. We earlier questioned Medium-lowCommunity whether “societal need” was being considered. Wait and see Month Day, 11 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 11
  • 12. Recent and Current Obesity R&D by Major Pharmaceutical Companies  Contrary to some opinions major pharmaceutical companies have not walked away from researching drugs for obesity and weight management R&D Compound Manufacturer Clinical Trial Stage BMS-830216 Bristol-Myers Squibb Phase 1, 2 ‘2-0453 Novo Nordisk Phase 1,2 GSK-1521498 GlaxoSmithKline Phase 2 PF-04620110 Pfizer/Bristol-Myers Phase 1 Velneperit (S-2367) Shionogi Phase 2 Exenatide Amylin/Eli Lilly Phase 4 Pramlintide+Metreleptin Amylin/Takeda Phase 2 Month Day, 12 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 12
  • 13. Physician Obesity Study Findings and Implications Month Day, 13 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 13
  • 14. Obesity Drugs - Study Design Country  USA Dates of Fieldwork  Summer, 2010 Data Collection Method  Online  JPEG Concept Specs  1 pg Sample Size  N=1500 (> 125 exposures per concept)  General Practice Physicians, in practice between 2 and 35 years, Endocrine and Cardiac subspecialties Sample Definition included, geographically dispersed.  Internet access  Sequential monadic survey Exposure Method  3 concepts per respondent  Test concept exposure rotated to avoid order bias Length of Survey  15 minutes Month Day,14 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 14
  • 15. Profiles: Investigational drugs with proposed indications for treatment of obesity Lorqess (possible TM Qnexa Contrave for lorcaserin) Orexigen Manufacturer Arena Pharma Vivus Therapeutics U.S. Commercialization Eisai None announced Takeda Partner Fixed-dose combo of Fixed-dose combo of Lorcaserin Formula hydrochloride generic phentermine and generic bupropion topiramate and naltrexone Four dosage strengths for Maintenance dose titration. Maximum after titration - 8mg Single 10mg maintenance dose - 15 mg Dosing tablet, BID naltrexone + 90 mg phentermine + 92 mg ER bupropion , 2 ER topiramate, Single capsule, tablets, BID QD Month Day, 15 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 15
  • 16. Percent of patients treated for obesity for whom the drug is appropriate  Physicians mention that lorcaserin and Contrave would be appropriate for about one-half of their obesity patients. 100% 80% 60% 52% 47% Patients for whom 39% 40% drug would be appropriate 20% 0% Lorcaserin Qnexa Contrave Month Day, 16 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 16
  • 17. Comparisons to currently available medications to treat obesity  Lorcaserin is most thought of as a break-through treatment.  Qnexa is viewed as most similar to existing medications (phentermine and topiramate). 100% 15% Is a breakthrough new 22% treatment 80% 41% 60% Offers some 66% improvement compared 71% to existing medications 40% 52% Similar to existing 20% medications and does 18% not offer any meaningful 6% 7% improvement 0% Lorcaserin Qnexa Contrave Month Day, 17 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 17
  • 18. Time to make drugs a standard therapy  The overwhelming majority of physicians state that they would make any of the drugs a standard therapy within two years. 100% 92% 86% 80% 72% 35% Less than 2 years 32% 60% 34% Between 1-2 years 40% 54% 57% Less than 1 year 20% 38% 0% Lorcaserin Qnexa Contrave Month Day, 18 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 18
  • 19. Key measures suggest that lorcaserin has a high likelihood of achieving in-market success  The product scores in the top 20% of norms on key measures such as prescribing intent, uniqueness and need fulfillment. Lorcaserin Key Measure Scorecard Bottom 20 Below Above Top 20 Percentile Average Average Average Percentile Seek Information 85% (Top Two Box %) Prescribe Intent 27% (Top Box %) Prescribe Intent, When Asked 70% (Top Two Box %) New and Different 3.9 (Mean 5-Point Scale) Need Fulfillment 71% (Top Two Box %) Believability 20% (Top Box %) Scores compared to Vantis norms for over 500 similar and relevant products Month Day, 19 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 19
  • 20. If approved, key measures indicate an average probability of market success for Qnexa  Most key measures fall in the middle of the range of normative scores when compared to the Vantis new product data base. Qnexa Key Measure Scorecard Bottom 20 Below Above Top 20 Percentile Average Average Average Percentile Seek Information 74% (Top Two Box %) Prescribe Intent (Top Box %) 19% Prescribe Intent, When Asked 50% (Top Two Box %) New and Different 3.2 (Mean 5-Point Scale) Need Fulfillment 56% (Top Two Box %) Believability 22% (Top Box %) Scores compared to Vantis database of norms for over 500 similar and relevant products Month Day, 20 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 20
  • 21. Contrave is very well-placed to enter the market   With almost all key measures falling in the top quintile, when compared to Vantis’ norms, we expect that Contrave will achieve market success if approved. Contrave Key Measure Scorecard Bottom 20 Below Above Top 20 Percentile Average Average Average Percentile Seek Information 87% (Top Two Box %) Prescribe Intent 28% (Top Box %) Prescribe Intent, When Asked 76% (Top Two Box %) New and Different 3.7 (Mean 5-Point Scale) Need Fulfillment 66% (Top Two Box %) Believability 28% (Top Box %) Scores compared to Vantis database of norms for over 500 similar and relevant products Month Day, 21 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 21
  • 22. Key Measures Summary  All three drugs have a reasonable chance of success if approved by the FDA. Summary Key Measure Scorecard Bottom 20 Below Above Top 20 Percentile Average Average Average Percentile Seek Information Q L C (Top Two Box %) Prescribe Intent Q L,C (Top Box %) Prescribe Intent, When Asked Q L,C (Top Two Box %) New and Different Q L,C (Mean 5-Point Scale) Need Fulfillment Q L,C (Top Two Box %) Believability L Q C (Top Box %) Scores compared to Vantis database of norms for over 500 similar and relevant products Month Day, 22 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 22
  • 23. Ipsos Vantis Forecast Ranges  Forecasts made during summer of 2010 - before Advisory Committee meetings and FDA review of NDAs  Assumes that manufacturers partner with large pharma company for U.S, commercialization.  Our order of entry assumptions have changed. 800 760 700 Annual U.S. sales 590 (retail) within 5 years 600 520 of launch Millions of Dollars 500 570 400 440 300 390 200 100 0 Lorcaserin Qnexa Contrave Month Day, 23 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 23
  • 24. What does the future hold?   Based on our research with doctors, we predict an overall market more accepting of Rx pharmaceutical solutions to weight loss – even in the case where there is a more severe risk profile. This is based on our recent research of physicians.   In the future, all doctors will ask themselves when suggesting diet and exercise if it will be effective and if it is enough for the patient in question.   It is very possible that some drugs will havel limiting labeling (indication for BMI > 32), or a very serious co-morbidity.   But the larger societal/public health issue can only partially be met with such solutions – and as with bariatric surgery, the Rx approach is never going to be a broad solution for a wide percentage of patients.   The FDA seems to be evaluating the new entrants on merits and meeting the public need halfway with the actions of the last few days   While we think all marketers and strategists in the Rx industry should be ready to think about obesity agents, the top pharmaceutical companies are not in this category now, have definitely made strategic decisions in this regard, and we won’t see them back for at least five years, based on the pipeline.   As stated, we see Lorcaserin, Qnexa and Contrave entering the market and in general being quite successful, based on good/superior physician reaction. Month Day,24 Year© 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar Page 24

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