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Trendsmeme™ | White Paper
Metabolic Disorders
FDA Approves First New Anti-Obesity
Drug in More Than a Decade
All eyes are on the anti-obesity market this summer now that the FDA has approved Arena
Pharmaceuticals’ lorcaserin—to be marketed under the name Belviq (formerly Lorqess)
by Arena’s partner Eisai in the United States. Belviq is a 5-HT2C receptor agonist that has
serotonergic and anorectic properties and resulted in 3.1% weight loss on average in clinical
trials, although half of patients lost at least 5% of their starting weight. And just a month from
now, another anti-obesity drug has a scheduled PDUFA data, signaling both new options for
battling a worldwide health epidemic and a new level of competition in the obesity treatment
marketplace.
“The approval of this drug, used responsibly in combination with a healthy diet and lifestyle,
provides a treatment option for Americans who are obese or are overweight and have at least
one weight-related comorbid condition,” said the FDA’s drug center director, Dr. Janet Woodcock.
The first anti-obesity drug to hit the market since 1999 (Xenical), this approval is a boon not just
to Arena and to Eisai but to other companies in this space, given the signal that the FDA is open
to approvals with appropriate measures. Competitors to Belviq wait in the wings, among them
Vivus’s Qnexa and Orexigen’s Contrave. The medical community eagerly awaits new therapies
but safety concerns remain. Earlier-stage drugs from small companies act on novel mechanisms
of action and might prove to be a safer and more efficacious approach to obesity. Clinical trials
will have to explore the possibilities.
According to a favorable FDA panel decision earlier in 2012, previously voiced fears about
cardiovascular and cancer risks were unfounded but more study was needed. Prior to the FDA
decision, Arena had agreed to conduct a postmarketing safety study in obese pediatric patients
and overweight or obese patients with cardiovascular disease or cardiovascular risk factors. The
approval comes with this caveat: “The safety and efficacy of coadministration of BELVIQ with
other products intended for weight loss and the effect of BELVIQ on cardiovascular morbidity
and mortality have not been established.” Further, Belviq will be considered a scheduled
substance.
This decision is also one piece of a multifaceted push to address the intertwined problems of
metabolic disorders, cardiovascular disorders, and other major contributors to costly morbidity
and mortality trends. Obesity is a root cause of type 2 diabetes, cardiovascular disease, cancer,
and other serious sequelae. “Obesity threatens the overall well being of patients and is a major
public health concern,” Woodcock said.
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Trendsmeme™ | White Paper
In the wake of the approval, Seeking Alpha quoted the U.S. market potential for obesity therapies
at $60.9 billion and predicted that Arena could net $300-500 million of it annually. On Belviq’s
approval, Arena shares have increased by 30%, according to Seeking Alpha.
Many analysts peg Vivus’s Qnexa, a combination phentermine/topiramate drug, as the emerging
obesity therapy most likely to succeed clinically and commercially. Data show that its weight-loss
effects are greater than those achieved by rivals Belviq and Contrave—Qnexa promises to yield
10% weight loss on average versus 3.1% for Belviq. Qnexa stimulates norepinephrine release to
suppress hunger with the low dose of phentermine and induces weight loss with a low dose of
topiramate via an unknown mechanism. The FDA is scheduled to make a decision on Qnexa on
July 17, 2012. Indeed, conference presentation and journal publications titles in the Medmeme
database concerning emerging anti-obesity therapies show the greater activity overall for Qnexa
(see Figure 1).
Activity for Late-Stage Obesity Therapies in the Medmeme Database, 2009-2011 Figure 1
8
No. of Conference Presentation and
Journal Publication Titles
6
4
2
Qnexa
Contrave
0 Lorqess*
2009 2010 2011
Note: Based on a search of compound names in conference and journal abstracts. © Medmeme LLC. 2012
*Lorqess was FDA approved on June 27, 2012, and will reach the market with a new brand name, Belviq.
Source: Medmeme LLC.
A caveat: Qnexa contains phentermine, which was a component of the notorious Fen-Phen
anti-obesity combination that failed spectacularly in the 1980s. So, there is anticipation that
cardiac side effects could be an issue with this drug, along with the side effects of topiramate,
which include drowsiness, dizziness, and GI upset.
Keep an eye also on a competing approach: bariatric surgery (see Figure 2). According to
reports, obese patients undergoing bariatric surgery are not only achieving and sustaining
© 2012, Medmeme LLC. | +1 212-725-5992 | info@medmeme.com | www.medmeme.com

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Trendsmeme™ | White Paper
weight loss but also managing to decrease the dose of their type 2 diabetes medications, or
eliminate them altogether.
Activity for Obesity Bariatric Surgery in the Medmeme Database, 2009-2011 Figure 2
250
No. of Conference Presentation and
200
Journal Publication Titles
150
100
50
Conference Presentations
0 Journal Articles
2009 2010 2011
Source: Medmeme LLC. © Medmeme LLC. 2012
Safety concerns, of course, are an issue for all obesity drugs, given the history of adverse
reactions, drug withdrawals, litigation, and a strict regulatory environment in this area. This
will be an area to watch as Belviq and, potentially, its competitors are rolled out onto the
marketplace.
© 2012, Medmeme LLC. | +1 212-725-5992 | info@medmeme.com | www.medmeme.com

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About Medmeme
Medmeme, LLC, is a global database company that offers comprehensive knowledge about
the people, institutions, and research that drive medical practice in all major therapeutic areas.
Founded in 2006, Medmeme serves pharmaceutical and biotechnology clients worldwide,
including 16 of the leading 20 pharmaceutical companies.
Our proprietary database of thought leaders, medical meetings, clinical trials, and Centers-of-
Excellence provides intelligence that allows clients to reach the most important channels through
which medical information travels. Detailed profiles of medical science experts, including their
medical contributions, levels of influence, and professional networks, allow clients to strengthen
product messaging by enlisting thought leaders whose opinions increasingly shape medical
practice. In addition, by identifying effective research practices, investigators, and sites, our
products help clients improve clinical trial effectiveness while reducing costs.
Our Approach
Medmeme’s approach is designed to help clients meet the multifaceted challenges facing the
healthcare industry, including demand for specialty medical treatments with better outcomes,
the high costs of developing these treatments, and pressure from patients and payers to keep
treatment costs under control.
Finding a better balance among these challenges requires gathering more focused and detailed medical
knowledge. To achieve this goal, Medmeme has developed a unique system of finding, validating, and
analyzing data using proprietary algorithms and platforms that deliver in-depth information across
drugs and disease areas in 50 countries. The quality, breadth, and detail of our data set us apart:
• Credible - We use only the most reliable sources, such as governments, medical societies, and
accredited medical institutions
• Accurate - Medmeme processes data using proprietary algorithms, first to normalize it to standardize
fields for easy comparison, followed by a disambiguation process that prevents duplication. Data is
then integrated across database platforms to provide a comprehensive view of each therapeutic area.
• Comprehensive - We aggregate 50 million data points from more than 60,000 sources
worldwide. Ten-year historical records encompass clinical trials, meetings, publications, grants,
patents, treatment guidelines, and more.
• Forward-looking - Updated daily, our database includes information on emerging as well as
developed markets, and on promising as well as established thought leaders.
Flexible Solutions
Medmeme can offer database solutions based on client-specified needs, including segmentation
by disease, therapeutic area, compound, drug class, development phase, country/region, keyword,
and more. Client-specified search parameters provide targeted information to support functions
across the organization.
Medmeme offers annual subscriptions to our proprietary database platforms. We also provide syndicated
reports for those who want data compiled by therapeutic area. Discounts for longer subscriptions
and multiple-product purchases make it economical to acquire greater quantities of information.
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About Medmeme
About Medmeme Syndicated Reports
Medmeme reports slice the data by therapeutic categories from more than 60,000 URLs yielding
50 million data points, the professional bodies of work of over 1.5 million key opinion leaders, more
than 6.3 million medical conference presentations, over 600,000 clinical trials in 50 countries, and
information from governments, societies, and institutions to map, measure, and project the pathways
of future market movement. Medmeme’s data-intensive reports compile and analyze trends over
time to show the top conferences, the top journals, the top contributors, the top institutions, and
more, to illustrate—using easily navigated text and extensive tables and graphs—the most successful
approaches to creating awareness, interest, and demand in any therapeutic category.
• Trendsmeme™ Reports – These reports cover key indications, companies, and drugs to reveal
dominant player positioning as well as relevant issues and developments in treatment and the
marketplace. They explain the status of a therapeutic category and the major trends that are
driving change and influencing R&D success.
• Intellmeme™ Reports – Reports that identify the disease areas and drugs that receive the most
attention—that is, the largest share-of-voice—from peer-reviewed medical journals, societies,
meetings and congresses, and key opinion leaders. They illustrate trends over time and highlight
strategic options.
• C-O-E/meme™ Reports – These reports pinpoint the top 50 medical centers-of-excellence by
specific therapeutic categories, giving guidance for selection of partners to conduct clinical
research, recruit KOLs for specific disease expertise and affiliations, provide educational
initiatives, and more. The reports are a direct derivative of Medmeme’s on-line, continuously
updated, searchable database product platform C-O-E/meme™.
• Trialmeme™ Reports – The reports identify, by location, leading clinical trial sites worldwide,
including principal and site investigators, trial status, entity conducting the trial, drug, and where the
results have been presented. This knowledge can help reduce both trial timelines and costs of future
trials by providing historic perspective to sponsors and CROs. The reports are a direct derivative of
Medmeme’s on-line, continuously updated, searchable database product platform Trialmeme™.
These syndicated reports can be purchased separately, based on therapeutic category of interest,
or by series at discounted pricing. To learn more about the reports, see www.medmeme.com/
products/syndicated-reports.
To purchase Reports or for more information, contact
Ray Wright, Vice President, Sales Yan Barshay, Executive Vice President Mahesh Naithani, CEO
+1 508-278-4595 +1 212-725-5992 +1 212-725-5990
rwright@medmeme.com yan@medmeme.com mahesh@medmeme.com
© 2012, Medmeme LLC. | +1 212-725-5992 | info@medmeme.com | www.medmeme.com