ipsos vantis qnexa obesity drug test results

Vantis Health Files

Linking Market Research to Market Performance

Qnexa (phentermine and topiramate) for Obesity

Sept 16, 2010

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

[email protected]

© 2010 Ipsos Vantis Health Files 2

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.

Qnexa (phentermine and topiramate combination) – obesity

Qnexa was developed by Vivus, Inc., to treat obesity with or without co-morbidities, in conjunction with diet and exercise. The drug is an oral, once-a-day, controlled-release formulation combining low doses of generic phentermine and topiramate, which address both appetite and satiety in one capsule. Qnexa appears to induce significantly greater weight loss than either individual compound and clinical trials have demonstrated superior efficacy with a significantly improved safety profile as compared to either active agent alone. Phentermine has been available to treat obesity since the 1950s and is still the most widely prescribed weight loss therapy, while Topiramate was approved in 1996 to treat epilepsy and more recently, as a prophylactic for migraine. The NDA has been accepted for full 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 low dose of the compound and combining it with phentermine, which acts via a different mechanism. Topiramate works via Y-Aminobutyric acid (GABA) the primary inhibitory neurotransmitter in the central nervous system and increases satiety, while phentermine is noradrenergic and non-serotonergic and reduces appetite. Three pivotal Phase 3 clinical trials evaluating more than 4,500 patients have been completed. EQUATE evaluated 756 obese subjects over 28 weeks, EQUIP evaluated 1,267 morbidly obese patients with and without co-morbidities over 56 weeks and CONQUER evaluated 2,487 overweight and obese patients with at least two co-morbid conditions.

In Phase 3 clinical trials, FDA efficacy benchmarks for weight loss agents were exceeded at all three doses. In the EQUIP study, after 56 weeks, completers with an average BMI baseline of 42.1 experienced a mean weight loss of 7.0% (18 lbs) at the low dose and 14.7% (37 lbs) at full dose. In the CONQUER study, after 56 weeks, completers who were obese with co-morbidities (hypertension, dyslipidemia or type 2 diabetes) and an average BMI baseline of 36.6 achieved a mean weight loss of 10.5% (24 lbs) at the mid dose and 13.2% (30 lbs) at full dose. Significant improvements in cardiovascular, metabolic and inflammatory risk factors were observed for patients treated with Qnexa. Qnexa is well tolerated and common side effects of dry mouth, tingling, constipation, altered taste expected and manageable. There were no signals of suicidality ideation for any of the treatment groups.

Third party reimbursement for weight loss drugs is limited but evolving. At the time of launch, Qnexa is not expected to be reimbursed.

Concept Shown to Physicians


Market Size & Potential The potential market for new prescription drugs to treat obesity and maintain weight loss is enormous. In the US, about $60 billion is spent every year on weight-loss products including diet programs, low-calorie foods and beverages, OTC supplements and appetite suppressants, gym memberships and exercise equipment, books, videos and bariatric surgery. 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, with an additional one-third considered overweight. The U.S. market for weight loss products is poised to expand nearly fourfold within a few years, and will shift from being largely generic to a mix of both branded and generic products. Beyond US potential, the World Health Organization estimates that 400 million of the world’s population is obese.

Current Treatment Options Treatments for weight loss and obesity range from behavioral modification to pharmaceutical therapies and surgical interventions. Modifications to diet and exercise are the preferred initial course of action, but the rigors of behavioral modification often cause significant attrition and weight re-gain over time. Pharmaceutical therapies are generally prescribed only after behavior modification has failed. Bariatric surgery, including gastric bypass and gastric banding procedures, is employed in more extreme cases and is gaining broader acceptance with an estimated one-quarter of a million people opting for the procedure in 2008. However, surgery is associated with significant side effects, potential complications 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 services for patients who met specific criteria; the Medicare statute dictates that surgical treatments for obesity alone are not covered because they are not considered reasonable and necessary.

Implanted devices used as therapies, such as neuromodulators, are not yet approved by the FDA; there are additional implantable devices and surgical tools in late-stage development.

Weight Loss and Pharmacotherapy As a result of the limited effectiveness and worrisome side effects of prescription weight loss products, 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 treat obesity. In the mid-1990s, “fen-phen” (fenfluramine or dexfenfluramine in combination with phentermine) was used extensively, off-label, to encourage weight loss. However, the product was withdrawn from the market in 1997 in response to suspected heart valve damage. Phentermine is still prescribed, but is a Class IV controlled substance, only indicated for short term use.

Overview:


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.


Key Findings: Qnexa - Weight Management

Market Potential

 Within 5 years of launch, Qnexa is expected to attain a significant share of a greatly expanded obesity market due to its competitively superior efficacy and flexible dosing options, which fit a wide variety of patient profiles.

Patient / Physician Target

 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 and expand the weight management category to patients not currently 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.

Communication Strategy

 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 and associated viral campaigns would be particularly effective 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.

Additional POV

 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 usually follows the recommendation of its advisory committees and 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.


83 0 67 133 200

Success of Concept Score

Although the Vantis Database consists of over 30,000 product evaluations, the scores of this study were compared to a subset of approximately 550 similar and relevant products.

Vantis Scores Market Performance Indicators

Success of Concept Score

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

Key Measure Scorecard Bottom 20 Percentile

Below Average Average

Above Average

Top 20 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 (Top Box %) 22%

30.1 0 50 100

Doctors who knew about this product


High Medium Low

The Qnexa proposition is expected to generate considerable buzz in the medical community with two-thirds of physicians agreeing that the drug will create a lot of excitement. This excitement translates into thought leadership among the prescribing universe, with nearly 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 by sales representatives, underscoring the importance of a strong launch plan. .

Communication Power Communication Power Index

Physician Communication Key Measures

41%

68%

0% 25% 50% 75% 100%

Top Two Box Agreement %

I would recommend this to my professional colleagues

This drug will create a lot of excitement and will be talked about by doctors

33.6 0 50 100

Physician Prescribing Comfort


2.7 0 5 10

Concept Sharpness Index

11.5 0 50 100

Message Power

Critical Success Factors Concept Highlighter

Physicians more likely to prescribe Qnexa are primarily driven by its strong performance versus FDA benchmarks, as well as its secondary benefits of reducing co-morbidity risk factors.

High Medium Low

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


Market Potential Summary As a result of limited effectiveness and worrisome side effects, less than 2% of U.S. adults who are obese or overweight receive pharmacotherapy. However, the three new investigational drugs currently under consideration by the FDA have demonstrated greater efficacy and more benign side effects, and are expected to lead to major category growth over the next several years. Since weight loss is a necessary step in treating major chronic diseases such as diabetes and cardiovascular conditions, and the new drugs address many unmet needs, these products are expected to provide a rebound and drive market growth. Some analysts predict the U.S. market could even grow to $5 billion within 5 years.

Assuming that Qnexa launches in partnership with a major pharmaceutical company, 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 three products’ order of entry, and their ability to obtain 3rd party reimbursement. Qnexa is not expected to be reimbursed upon launch and optimistically, it could be several years before legislation enables Medicare coverage. Currently only 10 states, covering about 14 million people, offer any coverage for prescription weight loss drugs through Medicaid, and formulary acceptance by HMOs is very limited.

Qnexa is expected to be used as first -line therapy for a broad range of patients who are obese or over weight with a weight-related, co-morbid condition.


Methodology

Country  USA

Dates of Fieldwork

 April 2010

Data Collection Method

 Online

Concept Specs

 JPEG  1 pg

Sample Size

 N=1500 (> 125 exposures per concept)

Sample Definition

 General Practice Physicians, in practice between 2 and 35 years, Endocrine and Cardiac subspecialties included, geographically dispersed.

 Internet access

Exposure Method

 Sequential monadic survey  3 concepts per respondent  Test concept exposure rotated to avoid order bias

Length of Survey

 15 minutes


Questionnaire Details – Key Measures

Key Measure Scorecard

Awareness

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 • 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

Seek Information   Which statement best describes how likely you would be to seek more

information about the product?   Response on a 5-Point Scale – “Definitely Would” to “Definitely Would Not”

Seek

Prescribing Intent   Which statement best describes how you feel about prescribing the product?   Response on a 5-Point Scale – “Definitely Would” to “Definitely Would Not”

Prescribe

Prescribing Intent, If Asked By Patient

  Which statement best describes how you feel about prescribing the product if a patient asked for a prescription?

  Response on a 5-Point Scale – “Definitely Would” to “Definitely Would Not” Prescribe if Asked

Uniqueness   How would you rate the product in terms of being new and different from

other products currently available?   Response on a 5-Point Scale – “Extremely New and Different” to “Not at All

New and Different”

Need Fulfillment   How well would the product solve a problem or fulfill a need for you?   Response on a 5-Point Scale – “Definitely Would” to “Definitely Would Not”

Believability   Which statement best describes how you feel about the believability of the

statements made about the product?   Response on a 4-Point Scale – “Very Believable” to “Not at All Believable”


Questionnaire Details

Communication Power

Agree/Disagree (5 pt scale)

  I would recommend this to my professional colleagues   This Drug will create a lot of excitement and will be talked about by doctors   I prefer to learn about new drugs from a detailing representative   I can’t really comment until I see leave-behind information from the

manufacturer


Market Success Score The market success score is a calculation of Mass Market Potential, scaled from 0 to 100 for simple interpretation. In contrast to a full forecast, the Market Success Score focuses only on consumer demand, and does not account for marketing plans (generating awareness and building distribution). 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-market sales 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 this annual Demand Express offer.

Key Measure Scorecard Survey scores for each new concept are compared to the Vantis Database. Vantis owns the world’s largest database of new concept scores in technology, durable goods, health, and services industries. By comparing scores of new products and services to the database, we can speak to the absolute strength about the survey scores. The individual key measure scores and their pattern are both important parts of the interpretation. The individual score (ie, low believability) can reveal a specific problem area. The pattern typically classifies into one of approximately 20 new product archetypes. Understanding the archetypes informs strategy and assists in communications development.

Success of Concept Score This score is an indexed score which combines all of the Vantis Key Measure scores into one number. The key measures are weighted differently according to their influence on prescribing activity.

Physician Prescribing Comfort Index This calculated index compares physicians’ willingness to recommend a drug with their perceptions of how much their colleagues will discuss and be excited about the drug. In general, doctors will have a slightly lower willingness to recommend a drug. However, when this difference is higher, it suggests that the doctor may not be comfortable prescribing the drug.

Concept Sharpness Index Concept Sharpness measures the difference between the top-cited reasons to prescribe and lower reasons. A “sharp” concept has a small number of attributes that have high ratings, and the “drop-off” or slope is steep.

Message Power Index Message Power looks at that percentage of doctors who choose the top attributes and combines that number with the Concept Sharpness Index.

Vantis Health File Deliverables


Ipsos Vantis is a world leader in forecasting and optimizing new products and services before they are introduced in market. Over the past 20 years Vantis has conducted 15,000 new product concept studies, and built the world’s largest database of new product survey scores in technology, durable goods, health, and services industries. Ipsos Vantis tracks its forecasts 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 market

Philosophy Forecasting validation is a necessity for our business in order to ensure the validity of the advice, but our attention is placed on delivering research that informs the right business decision. This requires stepping outside of research to understand the business problem, then asking “how” with respect to every aspect of marketing. Once we answer these questions, we can conduct research.

What matters most to our partners is how much money we earn them, or save them. Every Ipsos Vantis study delivers results that depict business and financial impact. Our unique expertise is our capability to translate survey data to business results. Research that speaks in terms of business impact, especially in financial terms (the universal business language), works its way through an organization more effectively and elevates the role of research within a company. Engineers, the sales force, finance, and management can be trained to understand survey scores, but they already understand sales, revenue, market share, and profits.

Vantis Health Files & the Vantis Philosophy Vantis Health Files serves several purposes. It could be used to prioritize early concepts, to gauge the threat of a new competitor that has just entered the market, or to disaster check a product before launch.

On one hand, Vantis Health Files is a standardized, scaled down, affordable and fast way to test new product and service concepts. On the other, it is a succinct collection of powerful market-proven metrics that relate to the three major components of any concept evaluation program: demand, targeting, messaging. While Vantis Health Files stop short of a sales forecast, its deliverables hold true to the philosophy of translating survey scores to business impact. Vantis Health Files will depict the opportunity for a new product or service, leaving little doubt as to the strength of your concept.

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