weight loss research and results and commentary on three pipeline drugs
Post on 21-Oct-2014
1.311 views
DESCRIPTION
TRANSCRIPT
Nobody’s Unpredictable December 9, 2010 © 2010 Ipsos• [name of the entity issuing the document]. All rights reserved. Contains Ipsos' Confidential and Proprietary information and may not be disclosed or reproduced without the prior written consent of Ipsos.
Results and Commentary on Three Pipeline Drugs Lorcaserin | Qnexa | Contrave
Ipsos*Vantis Weight Loss Research
Month Day, Year Page 2 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
2
Obesity Analytical Group
Bob Shekhdar - Senior Consultant Office: 203.329.8756 Mobile: 203.559.7620 [email protected]
Tom Young- Vice President, Healthcare Office: 973.658.1686 Mobile: 201.755.6096 [email protected]
Month Day, Year Page 3 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
3
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.
Disclaimer
Month Day, Year Page 4 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
4
Ipsos Overview
Ipsos-Novaction
Forecasting, modeling and consulting for FMCG & OTC drugs
Ipsos-Vantis Forecasting, modeling and consulting for Rx drugs, B2B medical devices and personal health care – as well as durable products, services & non-medical B2B
Ipsos-ASI
Advertising testing and brand health
Ipsos-Public Affairs
Public opinion
Qualitative & Quantitative research for Pharmaceutical industry
Health
Month Day, Year Page 5 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
5
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
About Ipsos*Vantis
Month Day, Year Page 6 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
6
Setting the Stage
Month Day, Year Page 7 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
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 Page 8 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
8
Timeline: FDA and Weight Loss Drugs
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
J&J tests topiramate, an epilepsy / migraine headache
drug, in weight loss trials
FDA forms Obesity Task Force
J&J discontinues Topomax (topiramate)
weight-loss trials
FDA rejects Zimulti (rimonabant) NDA due to psychological side effects
FDA gives OTC approval for low-dose orlistat (alli)
Pfizer and Merck in clinical trials to develop CB-1
blockers
Merck, Pfizer stop CB-1 trials
Vivus submits NDA for Qnexa
FDA asks Abbott to withdraw Meridia
(sibrutamine) from US market
Abbott withdraws
Meridia
Orexigen NDA for
Contrave
FDA says lorcaserin and Qnexa “Not approvable in present form”
Arena NDA for
lorcaserin
Antidepressant Wellbutrin (buproprion), in weight loss
clinical trials.
Sanofi-Aventis withdraws Zimulti (rimonabant) NDA
FDA 12/7 Advisory Committee voted for approval of Contrave
Advisory Panel vote splits 5-5 on Meridia withdrawal
Pharma C
ompanies
FDA
Month Day, Year Page 9 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
9
Wall Street Opinion on Weight Loss Drug Market
“We see a significant market opportunity in obesity, although this remains controversial among investors. We believe the lack of historical commercial success for obesity drugs has been a function of poor efficacy and intolerable side effects, both of which can be addressed by lorcaserin's profile.”
Jefferies and Company, 12/09
“Obesity is an epidemic; mortality escalates with weight; the cost-effectiveness argument is easy; the market is enormous. Hence, no one argues a good drug would not be a mega-blockbuster. The FDA remains a formidable hurdle.”
Jefferies and Company, 2/10
“We believe Qnexa would satisfy a significant 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 trial for Qnexa.”
Cowen & Company, 10/10
“While our view that lorcaserin may have the best shot at approval among the late-stage 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 Page 10 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
10
Understanding the obesity market from multiple viewpoints
Month Day, Year Page 11 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
11
One Concern – Is the FDA “out-of-sync?” Stakeholder Quick Facts/Evidence Enthusiasm
for New Rx Meds
Patients/Society 74% of Americans are overweight or obese (Forbes, 2007) The WHO says that obesity will eclipse undernutrition and
infectious disease as the number one world health problem
High
Physicians The focus of this presentation – extremely enthusiastic about having something to offer obese patients
Very High
Drug Manufacturers Many large companies have de-emphasized weight loss, with pipelines oriented around cancer, biologicals, CNS and other drugs that have a high unit cost.
High/Varied
The Investment Community
Generally aware of massive patient size, but analysts tend to be very enthusiastic, or at the opposite extreme
Varied
Managed Care We suspect that pharmacoeconomic benefit will eventually sway payors in favor of these drugs, but patient volume suggests that getting on formulary will be an uphill battle initially.
Moderate
Other businesses taking part in the $150 Billion Weight Loss Industry
No worries for this group. These medications are all taken as part of regimens, which always include diet and exercise. In fact, we note that structured diet program participants are very likely to take prescription pharmaceuticals.
Medium-High
The FDA/Regulatory Community
FDA action of this week was surprising. We earlier questioned whether “societal need” was being considered.
Medium-low Wait and see
Month Day, Year Page 12 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
12
Contrary to some opinions major pharmaceutical companies have not walked away from researching drugs for obesity and weight management
Recent and Current Obesity R&D by Major Pharmaceutical Companies
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, Year Page 13 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
13
Physician Obesity Study Findings and Implications
Month Day, Year Page 14 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
14
Obesity Drugs - Study Design
Country USA
Dates of Fieldwork Summer, 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
Month Day, Year Page 15 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
15
Profiles: Investigational drugs with proposed indications for treatment of obesity
Lorqess (possible TM
for lorcaserin) Qnexa Contrave
Manufacturer Arena Pharma Vivus Orexigen Therapeutics
U.S. Commercialization Partner
Eisai None announced Takeda
Formula Lorcaserin hydrochloride
Fixed-dose combo of generic phentermine and
topiramate
Fixed-dose combo of generic bupropion
and naltrexone
Dosing Single 10mg tablet, BID
Four dosage strengths for titration. Maximum
maintenance dose - 15 mg phentermine + 92 mg ER
topiramate, Single capsule, QD
Maintenance dose after titration - 8mg naltrexone + 90 mg bupropion , 2 ER
tablets, BID
Month Day, Year Page 16 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
16
Physicians mention that lorcaserin and Contrave would be appropriate for about one-half of their obesity patients.
Percent of patients treated for obesity for whom the drug is appropriate
52%
39% 47%
0%
20%
40%
60%
80%
100%
Lorcaserin Qnexa Contrave
Patients for whom drug would be appropriate
Month Day, Year Page 17 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
17
Lorcaserin is most thought of as a break-through treatment. Qnexa is viewed as most similar to existing medications (phentermine and
topiramate).
Comparisons to currently available medications to treat obesity
6% 18%
7%
52%
66% 71%
41%
15% 22%
0%
20%
40%
60%
80%
100%
Lorcaserin Qnexa Contrave
Is a breakthrough new treatment
Offers some improvement compared to existing medications
Similar to existing medications and does not offer any meaningful improvement
Month Day, Year Page 18 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
18
The overwhelming majority of physicians state that they would make any of the drugs a standard therapy within two years.
Time to make drugs a standard therapy
54% 38%
57%
32%
34%
35%
86%
72%
92%
0%
20%
40%
60%
80%
100%
Lorcaserin Qnexa Contrave
Less than 2 years
Between 1-2 years
Less than 1 year
Month Day, Year Page 19 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
19
Scores compared to Vantis norms for over 500 similar and relevant products
The product scores in the top 20% of norms on key measures such as prescribing intent, uniqueness and need fulfillment.
Key measures suggest that lorcaserin has a high likelihood of achieving in-market success
Lorcaserin Key Measure Scorecard
Bottom 20 Percentile
Below Average Average
Above Average
Top 20 Percentile
Seek Information (Top Two Box %) 85%
Prescribe Intent (Top Box %) 27%
Prescribe Intent, When Asked (Top Two Box %) 70%
New and Different (Mean 5-Point Scale) 3.9
Need Fulfillment (Top Two Box %) 71%
Believability (Top Box %) 20%
Month Day, Year Page 20 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
20
Scores compared to Vantis database of norms for over 500 similar and relevant products
Most key measures fall in the middle of the range of normative scores when compared to the Vantis new product data base.
If approved, key measures indicate an average probability of market success for Qnexa
Qnexa 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%
Month Day, Year Page 21 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
21
Scores compared to Vantis database of norms for over 500 similar and relevant products
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 Percentile
Below Average Average
Above Average
Top 20 Percentile
Seek Information (Top Two Box %) 87%
Prescribe Intent (Top Box %) 28%
Prescribe Intent, When Asked (Top Two Box %) 76%
New and Different (Mean 5-Point Scale) 3.7
Need Fulfillment (Top Two Box %) 66%
Believability (Top Box %) 28%
Contrave is very well-placed to enter the market
Month Day, Year Page 22 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
22
Scores compared to Vantis database of norms for over 500 similar and relevant products
All three drugs have a reasonable chance of success if approved by the FDA.
Key Measures Summary
Summary Key Measure Scorecard
Bottom 20 Percentile
Below Average Average
Above Average
Top 20 Percentile
Seek Information (Top Two Box %) Q L C
Prescribe Intent (Top Box %) Q L,C
Prescribe Intent, When Asked (Top Two Box %) Q L,C
New and Different (Mean 5-Point Scale) Q L,C
Need Fulfillment (Top Two Box %) Q L,C
Believability (Top Box %) L Q C
Month Day, Year Page 23 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
23
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.
Ipsos Vantis Forecast Ranges
760
520 590
570
390 440
0
100
200
300
400
500
600
700
800
Lorcaserin Qnexa Contrave
Mill
ions
of D
olla
rs
Annual U.S. sales (retail) within 5 years of launch
Month Day, Year Page 24 © 2010 Ipsos Ipsos Vantis Rx Weight Loss Medications Webinar
24
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.
What does the future hold?