Vantis Health Files                Qnexa (phentermine and                 topiramate) for Obesity                Companies...
Concept Shown to PhysiciansIpsos Vantis surveyed 125 physicians to gauge their prior knowledge andreceptivity to Qnexa. Th...
Overview:Market Size & PotentialThe potential market for new prescription drugs to treat obesity and maintain weight loss ...
Overview continued:Weight Loss and Pharmacotherapy (Cont’d) Acomplia (rimonabant) failed to get FDA approval in 2007 and w...
Key Findings: Qnexa - Weight                  Management                                 Within 5 years of launch, Qnexa ...
Vantis Scores                     Market Performance Indicators The Market Success measure indicates a middling likelihood...
Communication Power Communication Power IndexThe Qnexa proposition is expected to generate considerable buzz in the medica...
Critical Success Factors                   Concept HighlighterPhysicians more likely to prescribe Qnexa are primarily driv...
Market Potential SummaryAs a result of limited effectiveness and worrisome side effects, less than 2% ofU.S. adults who ar...
Methodology    Country             USA   Dates of                        April 2010   Fieldwork     Data   Collection   ...
Questionnaire Details – Key MeasuresKey Measure Scorecard                                Have you previously heard or read...
Questionnaire DetailsCommunication Power                                   I would recommend this to my professional coll...
Vantis Health File DeliverablesMarket Success ScoreThe market success score is a calculation of Mass Market Potential, sca...
About Ipsos Vantis                  Linking Market Research to Market PerformanceIpsos Vantis is a world leader in forecas...
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Ipsos Vantis Qnexa Obesity Drug Test Results

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Ipsos Vantis surveyed 125 physicians to gauge their prior knowledge and receptivity to Qnexa. This concept was compiled using publicly available sources and this research was not specifically commissioned by any company. This presents our views and analysis of Qnexa receptivity in the U.S. market.

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Ipsos Vantis Qnexa Obesity Drug Test Results

  1. 1. Vantis Health Files Qnexa (phentermine and topiramate) for Obesity Companies referenced in this Report: Abbott Laboratories Arena Pharmaceuticals Orexigen Therapeutics Roche Pharmaceuticals Vivus, Inc. For More Information, Contact: Thomas B. Young Direct: 973.658.1686 Mobile: 201-755-6096 Tom.Young@ipsos.comSept 16, 2010 Linking Market Research to Market Performance
  2. 2. Concept Shown to PhysiciansIpsos Vantis surveyed 125 physicians to gauge their prior knowledge andreceptivity to Qnexa. This concept was compiled using publicly availablesources and this research was not specifically commissioned by any company.Qnexa (phentermine and topiramate combination) – obesityQnexa was developed by Vivus, Inc., to treat obesity with or without co-morbidities, inconjunction with diet and exercise. The drug is an oral, once-a-day, controlled-releaseformulation combining low doses of generic phentermine and topiramate, which addressboth appetite and satiety in one capsule. Qnexa appears to induce significantly greaterweight loss than either individual compound and clinical trials have demonstrated superiorefficacy with a significantly improved safety profile as compared to either active agentalone. Phentermine has been available to treat obesity since the 1950s and is still the mostwidely prescribed weight loss therapy, while Topiramate was approved in 1996 to treatepilepsy and more recently, as a prophylactic for migraine. The NDA has been accepted forfull review by October, 2010 and Qnexa is expected to be launched in early 2011.The rationale for Qnexa is to expand topiramate’s therapeutic window by using a very lowdose of the compound and combining it with phentermine, which acts via a differentmechanism. Topiramate works via Y-Aminobutyric acid (GABA) the primary inhibitoryneurotransmitter in the central nervous system and increases satiety, while phentermine isnoradrenergic and non-serotonergic and reduces appetite. Three pivotal Phase 3 clinicaltrials evaluating more than 4,500 patients have been completed. EQUATE evaluated 756obese subjects over 28 weeks, EQUIP evaluated 1,267 morbidly obese patients with andwithout co-morbidities over 56 weeks and CONQUER evaluated 2,487 overweight andobese patients with at least two co-morbid conditions.In Phase 3 clinical trials, FDA efficacy benchmarks for weight loss agents were exceeded atall three doses. In the EQUIP study, after 56 weeks, completers with an average BMIbaseline of 42.1 experienced a mean weight loss of 7.0% (18 lbs) at the low dose and14.7% (37 lbs) at full dose. In the CONQUER study, after 56 weeks, completers who wereobese with co-morbidities (hypertension, dyslipidemia or type 2 diabetes) and an averageBMI baseline of 36.6 achieved a mean weight loss of 10.5% (24 lbs) at the mid dose and13.2% (30 lbs) at full dose. Significant improvements in cardiovascular, metabolic andinflammatory risk factors were observed for patients treated with Qnexa. Qnexa is welltolerated and common side effects of dry mouth, tingling, constipation, altered tasteexpected and manageable. There were no signals of suicidality ideation for any of thetreatment groups.Third party reimbursement for weight loss drugs is limited but evolving. At the time oflaunch, Qnexa is not expected to be reimbursed. © 2010 Ipsos Vantis Health Files 2
  3. 3. Overview:Market Size & PotentialThe potential market for new prescription drugs to treat obesity and maintain weight loss isenormous. In the US, about $60 billion is spent every year on weight-loss products includingdiet programs, low-calorie foods and beverages, OTC supplements and appetitesuppressants, gym memberships and exercise equipment, books, videos and bariatricsurgery. However, less than 1% of that annual expenditure is spent on prescription drugs.One-third of the adult US population (roughly 75 million people) is classified as obese, withan additional one-third considered overweight. The U.S. market for weight loss products ispoised to expand nearly fourfold within a few years, and will shift from being largely genericto a mix of both branded and generic products. Beyond US potential, the World HealthOrganization estimates that 400 million of the world’s population is obese.Current Treatment OptionsTreatments for weight loss and obesity range from behavioral modification topharmaceutical therapies and surgical interventions. Modifications to diet and exercise arethe preferred initial course of action, but the rigors of behavioral modification often causesignificant attrition and weight re-gain over time. Pharmaceutical therapies are generallyprescribed only after behavior modification has failed. Bariatric surgery, including gastricbypass and gastric banding procedures, is employed in more extreme cases and is gainingbroader acceptance with an estimated one-quarter of a million people opting for theprocedure in 2008. However, surgery is associated with significant side effects, potentialcomplications and substantial costs and recovery time.Surgery expense and insurance coverage has been a significant barrier to its acceptance.In February 2006, Medicare began covering certain designated bariatric surgical servicesfor patients who met specific criteria; the Medicare statute dictates that surgical treatmentsfor obesity alone are not covered because they are not considered reasonable andnecessary.Implanted devices used as therapies, such as neuromodulators, are not yet approved bythe FDA; there are additional implantable devices and surgical tools in late-stagedevelopment.Weight Loss and PharmacotherapyAs a result of the limited effectiveness and worrisome side effects of prescription weight lossproducts, less than 2% of overweight or obese adults in the US receive pharmacotherapy.The pharmaceutical industry has had a checkered history of developing drugs to treatobesity. In the mid-1990s, “fen-phen” (fenfluramine or dexfenfluramine in combination withphentermine) was used extensively, off-label, to encourage weight loss. However, theproduct was withdrawn from the market in 1997 in response to suspected heart valvedamage. Phentermine is still prescribed, but is a Class IV controlled substance, onlyindicated for short term use. © 2010 Ipsos Vantis Health Files 3
  4. 4. Overview continued:Weight Loss and Pharmacotherapy (Cont’d) Acomplia (rimonabant) failed to get FDA approval in 2007 and was later withdrawn in Europe. Meridia (sibutramine) has received a stronger warning In the US due to associated risks of heard disease, and has been removed from the European market altogether. Xenical (orlistat), a drug approved for longer term use, can cause undesirable bowel-related problems in some patients, and is now also marketed over-the-counter as alli. Next-Generation Drugs and Qnexa The introductions of three new investigational drugs currently under consideration by the FDA are expected to transform the market from unsatisfactorily weak to a major therapeutic category. Security analysts have estimated the size of the pharmacologic weight loss market in the US to be as much as $5 billion by 2015. This new group of drugs consists of LORQESS/lorcaserin (Arena Pharmaceuticals), Contrave (Orexigen Therapeutics) and Qnexa (Vivus) , which is the focus of this research. Qnexa is a partially controlled-release formulation that combines low doses of generic phentermine and topiramate, which address both appetite suppression and satiety in one capsule. Phentermine is released immediately while topiramate is time-released. Both actives, as single agents, have already been approved by the FDA; phentermine has been available to treat obesity since the 1950s, while topiramate was approved for epilepsy in 1996 and more recently as a prophylactic for migraine. Topiramate works through the primary inhibitory neurotransmitter in the central nervous system, and increases satiety, while phentermine is noradrenergic and non-serotonergic and reduces appetite. The combination of two actives seems to alleviate the plateau effect observed with traditional single-ingredient drugs. Qnexa Product Launch Considerations Qnexa is expected to be used as first -line therapy for a broad range of patients who are either obese or overweight with at least one weight-related, co-morbid condition. Some physicians who specialize in obesity currently prescribe generic phentermine and topiramate as an off-label treatment for weight loss. Therefore, Qnexa is in a unique position as it will essentially compete with a lower-priced version of itself, assuming patients and physicians continue to accept the generic equivalent rather than a branded product. This dynamic could constrain Qnexa’s market potential . Additionally, Qnexa’s label may be further restricting since phentermine is a Class IV controlled substance. Uptake for Qnexa will be affected by the three products’ order of entry as well as by their ability to obtain 3rd party reimbursement. Upon introduction, Qnexa is not expected to be reimbursed. Medicare’s prescription drug benefit does not currently cover weight loss drugs and it will likely take several years before legislation can be amended to obtain coverage. Currently only 10 states, covering about 14 million people, offer any sort of coverage for prescription weight loss drugs through Medicaid. Formulary acceptance by HMOs is very limited. Given the widespread need and strong interest among both physicians and patients to treat obesity, e-marketing, viral campaigns and DTC advertising should prove particularly effective at generating awareness among prescribing physicians and potential patients. © 2010 Ipsos Vantis Health Files 4
  5. 5. Key Findings: Qnexa - Weight Management   Within 5 years of launch, Qnexa is expected to attain a significant Market share of a greatly expanded obesity market due to its competitively Potential superior efficacy and flexible dosing options, which fit a wide variety of patient profiles.   Qnexa has the potential to be used as first-line therapy for overweight (BMI > 27 with a weight-related co-morbidity) and obese patients, who need long term treatment.   Qnexa is expected to replace currently available agents andPatient / Physician expand the weight management category to patients not currently Target receiving pharmacotherapy.   The drug is expected to be heavily marketed to primary care physicians, who currently account for approximately 90% of total weight loss prescriptions.   Vivus is seeking a major pharmaceutical company with global reach to partner in the launch of Qnexa.   Given the ever-increasing presence of online weight loss education, resources, and product merchandising, e-marketing Communication and associated viral campaigns would be particularly effective Strategy methods to generate product awareness among potential patients.   Qnexa would benefit from messaging that focuses on “best weight loss in its class” as well as its safety profile, which is significantly better than either active agent alone.   NDAs for three new obesity drugs (Qnexa, LORQESS/lorcaserin and Contrave) have already been submitted to the FDA.   Recently, the Endocrinologic and Metabolic Drugs Advisory Committee narrowly voted against recommending approval for both LORQESS/lorcaserin and Qnexa. Safety concerns overrode potential benefits of the drugs. Although non-binding, the FDA Additional usually follows the recommendation of its advisory committees and POV a final decision on approval for both drugs is expected on the PDUFA dates scheduled for late October, 2010.   Qnexa sales could be negatively impacted by physicians’ off-label prescribing of generic phentermine and topiramate for weight loss.   Phentermine’s status as a Class IV controlled substance could further negatively impact the product’s uptake and acceptance. © 2010 Ipsos Vantis Health Files 5
  6. 6. Vantis Scores Market Performance Indicators The Market Success measure indicates a middling likelihood that Qnexa can achieve in-market success based on product merits alone; marketing and launch execution will be critical in bolstering its acceptance. The drug scores in the middle quintile of the Ipsos Vantis database on most key measures, though is above average on perceived uniqueness. Prior Awareness Doctors who knew about this product 30.1 0 50 100 Success of Concept Score Success of Concept Score 83 0 67 133 200 Key Measure Scorecard Bottom 20 Below Above Top 20 Percentile Average Average Average Percentile Seek Information (Top Two Box %) 74% Prescribe Intent (Top Box %) 19% Prescribe Intent, When Asked (Top Two Box %) 50% New and Different (Mean 5-Point Scale) 3.2 Need Fulfillment (Top Two Box %) 56% Believability 22% (Top Box %)Although the Vantis Database consists of over 30,000 product evaluations, the scores of this study werecompared to a subset of approximately 550 similar and relevant products. © 2010 Ipsos Vantis Health Files 6
  7. 7. Communication Power Communication Power IndexThe Qnexa proposition is expected to generate considerable buzz in the medicalcommunity with two-thirds of physicians agreeing that the drug will create a lot ofexcitement. This excitement translates into thought leadership among the prescribing universe, withnearly half of physicians claiming they would recommend the product to their colleagues.Despite the strong anticipation for this product, about half will still rely on information provided bysales representatives, underscoring the importance of a strong launch plan.. Low Medium High Physician Prescribing Comfort 33.6 0 50 100 Physician Communication Key Measures I would recommend this to my professional colleagues 41% This drug will create a lot of excitement and will be 68% talked about by doctors 0% 25% 50% 75% 100% Top Two Box Agreement % © 2010 Ipsos Vantis Health Files 7
  8. 8. Critical Success Factors Concept HighlighterPhysicians more likely to prescribe Qnexa are primarily driven by its strong performance versus FDAbenchmarks, as well as its secondary benefits of reducing co-morbidity risk factors. Low Medium High Concept Sharpness Index 2.7 0 5 10 Message Power 11.5 0 50 100 Significant improvements in cardiovascular, metabolic and inflammatory risk factors were observed for patients treated with Qnexa FDA efficacy benchmarks for weight loss agents were exceeded at all three doses. controlled-release formulation combining low doses of generic phentermine and topiramate, which address both appetite and satiety in one capsule clinical trials have demonstrated superior efficacy with a significantly improved safety profile as compared to either active agent alone. In the CONQUER study, completers who were obese w/co- morbidities & average BMI baseline of 36.6 achieved a mean weight loss of 10.5% at mid dose & 13.2% at full dose There were no signals of suicidality ideation for any of the treatment groups Topiramate works via Y-Aminobutyric acid (GABA) primary inhibitory neurotransmitter in central nervous system & increases satiety © 2010 Ipsos Vantis Health Files 8
  9. 9. Market Potential SummaryAs a result of limited effectiveness and worrisome side effects, less than 2% ofU.S. adults who are obese or overweight receive pharmacotherapy. However,the three new investigational drugs currently under consideration by the FDAhave demonstrated greater efficacy and more benign side effects, and areexpected to lead to major category growth over the next several years. Sinceweight loss is a necessary step in treating major chronic diseases such asdiabetes and cardiovascular conditions, and the new drugs address manyunmet needs, these products are expected to provide a rebound and drivemarket growth. Some analysts predict the U.S. market could even grow to $5billion within 5 years.Assuming that Qnexa launches in partnership with a major pharmaceuticalcompany, Ipsos expects annual retail sales in the U.S. to be in the range of$390-520 million within 5 years. The uptake will be affected by the threeproducts’ order of entry, and their ability to obtain 3rd party reimbursement.Qnexa is not expected to be reimbursed upon launch and optimistically, itcould be several years before legislation enables Medicare coverage.Currently only 10 states, covering about 14 million people, offer any coveragefor prescription weight loss drugs through Medicaid, and formulary acceptanceby HMOs is very limited.Qnexa is expected to be used as first -line therapy for a broad range ofpatients who are obese or over weight with a weight-related, co-morbidcondition. © 2010 Ipsos Vantis Health Files 9
  10. 10. Methodology Country  USA Dates of  April 2010 Fieldwork Data Collection  Online Method Concept  JPEG Specs  1 pg Sample  N=1500 (> 125 exposures per concept) Size  General Practice Physicians, in practice between 2 and Sample 35 years, Endocrine and Cardiac subspecialties Definition included, geographically dispersed.  Internet access  Sequential monadic survey Exposure  3 concepts per respondent Method  Test concept exposure rotated to avoid order bias Length of  15 minutes Survey© 2010 Ipsos Vantis Health Files 10
  11. 11. Questionnaire Details – Key MeasuresKey Measure Scorecard Have you previously heard or read about the concept? •  I have read about it in medical journal articles •  I have seen information about it in news articles Awareness •  I heard about it at a medical conference •  I have heard of this from colleagues •  I have discussed this with the manufacturer’s detail representatives •  It sounds familiar, but I am not sure if I have heard of this specific drug •  I was not aware of this before today   Which statement best describes how likely you would be to seek more information about the product? Seek Information   Response on a 5-Point Scale – “Definitely Would” to “Definitely Would Not” Seek   Which statement best describes how you feel about prescribing the product? Prescribing Intent   Response on a 5-Point Scale – “Definitely Would” to “Definitely Would Not” Prescribe   Which statement best describes how you feel about prescribing the product if Prescribing Intent, If a patient asked for a prescription? Asked By Patient   Response on a 5-Point Scale – “Definitely Would” to “Definitely Would Not” Prescribe if Asked   How would you rate the product in terms of being new and different from other products currently available? Uniqueness   Response on a 5-Point Scale – “Extremely New and Different” to “Not at All New and Different”   How well would the product solve a problem or fulfill a need for you? Need Fulfillment   Response on a 5-Point Scale – “Definitely Would” to “Definitely Would Not”   Which statement best describes how you feel about the believability of the Believability statements made about the product?   Response on a 4-Point Scale – “Very Believable” to “Not at All Believable” © 2010 Ipsos Vantis Health Files 11
  12. 12. Questionnaire DetailsCommunication Power   I would recommend this to my professional colleagues   This Drug will create a lot of excitement and will be talked about by doctors Agree/Disagree   I prefer to learn about new drugs from a detailing representative (5 pt scale)   I can’t really comment until I see leave-behind information from the manufacturer © 2010 Ipsos Vantis Health Files 12
  13. 13. Vantis Health File DeliverablesMarket Success ScoreThe market success score is a calculation of Mass Market Potential, scaled from 0 to 100 for simpleinterpretation. In contrast to a full forecast, the Market Success Score focuses only on consumerdemand, and does not account for marketing plans (generating awareness and buildingdistribution). The Market Success Score is used to help your business prioritize ideas early,according to a market proven metric. A correlation of the Vantis Market Success Score to in-marketsales indicates that concepts with a top third score have a 70% success rate in market.Ballpark forecasting can also be conducted at the early concept stage, though that is not part of thisannual Demand Express offer.Key Measure ScorecardSurvey scores for each new concept are compared to the Vantis Database. Vantis owns the world’slargest database of new concept scores in technology, durable goods, health, and servicesindustries. By comparing scores of new products and services to the database, we can speak to theabsolute strength about the survey scores. The individual key measure scores and their pattern areboth important parts of the interpretation. The individual score (ie, low believability) can reveal aspecific problem area. The pattern typically classifies into one of approximately 20 new productarchetypes. Understanding the archetypes informs strategy and assists in communicationsdevelopment.Success of Concept ScoreThis score is an indexed score which combines all of the Vantis Key Measure scores into onenumber. The key measures are weighted differently according to their influence on prescribingactivity.Physician Prescribing Comfort IndexThis calculated index compares physicians’ willingness to recommend a drug with their perceptionsof how much their colleagues will discuss and be excited about the drug. In general, doctors willhave a slightly lower willingness to recommend a drug. However, when this difference is higher, itsuggests that the doctor may not be comfortable prescribing the drug.Concept Sharpness IndexConcept Sharpness measures the difference between the top-cited reasons to prescribe and lowerreasons. A “sharp” concept has a small number of attributes that have high ratings, and the “drop-off” or slope is steep.Message Power IndexMessage Power looks at that percentage of doctors who choose the top attributes and combinesthat number with the Concept Sharpness Index. © 2010 Ipsos Vantis Health Files 13
  14. 14. About Ipsos Vantis Linking Market Research to Market PerformanceIpsos Vantis is a world leader in forecasting and optimizing new products and servicesbefore they are introduced in market. Over the past 20 years Vantis has conducted 15,000new product concept studies, and built the world’s largest database of new product surveyscores in technology, durable goods, health, and services industries. Ipsos Vantis tracks itsforecasts vs. market launches and has observed a high degree of accuracy.   80% of forecasts are within 20% of actual sales results   Early stage concepts clearing the Vantis hurdles have a 70% success rate in marketPhilosophyForecasting validation is a necessity for our business in order to ensure the validity of theadvice, but our attention is placed on delivering research that informs the right businessdecision. This requires stepping outside of research to understand the business problem,then asking “how” with respect to every aspect of marketing. Once we answer thesequestions, we can conduct research.What matters most to our partners is how much money we earn them, or save them. EveryIpsos Vantis study delivers results that depict business and financial impact. Our uniqueexpertise is our capability to translate survey data to business results. Research thatspeaks in terms of business impact, especially in financial terms (the universal businesslanguage), works its way through an organization more effectively and elevates the role ofresearch within a company. Engineers, the sales force, finance, and management can betrained to understand survey scores, but they already understand sales, revenue, marketshare, and profits.Vantis Health Files & the Vantis PhilosophyVantis Health Files serves several purposes. It could be used to prioritize early concepts, togauge the threat of a new competitor that has just entered the market, or to disaster checka product before launch.On one hand, Vantis Health Files is a standardized, scaled down, affordable and fast way totest new product and service concepts. On the other, it is a succinct collection of powerfulmarket-proven metrics that relate to the three major components of any concept evaluationprogram: demand, targeting, messaging. While Vantis Health Files stop short of a salesforecast, its deliverables hold true to the philosophy of translating survey scores to businessimpact. Vantis Health Files will depict the opportunity for a new product or service, leavinglittle doubt as to the strength of your concept. © 2010 Ipsos Vantis Health Files 14

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