Ipsos Vantis Qnexa Obesity Drug Test Results1. 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.com
Sept 16, 2010 Linking Market Research to Market Performance
2. Concept Shown to Physicians
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.
© 2010 Ipsos Vantis Health Files 2
3. Overview:
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.
© 2010 Ipsos Vantis Health Files 3
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. 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 and
Patient / 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. 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 were
compared to a subset of approximately 550 similar and relevant products.
© 2010 Ipsos Vantis Health Files 6
7. Communication Power
Communication Power Index
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.
.
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. 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.
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. 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.
© 2010 Ipsos Vantis Health Files 9
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. Questionnaire Details – Key Measures
Key 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. Questionnaire Details
Communication 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. Vantis Health File Deliverables
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.
© 2010 Ipsos Vantis Health Files 13
14. About Ipsos Vantis
Linking Market Research to Market Performance
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
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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.
© 2010 Ipsos Vantis Health Files 14