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Metabolic   Disorders White Paper
 

Metabolic Disorders White Paper

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    Metabolic   Disorders White Paper Metabolic Disorders White Paper Document Transcript

    • 1 Trendsmeme™ | White PaperMetabolic DisordersFDA Approves First New Anti-ObesityDrug in More Than a DecadeAll eyes are on the anti-obesity market this summer now that the FDA has approved ArenaPharmaceuticals’ 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 hasserotonergic and anorectic properties and resulted in 3.1% weight loss on average in clinicaltrials, although half of patients lost at least 5% of their starting weight. And just a month fromnow, another anti-obesity drug has a scheduled PDUFA data, signaling both new options forbattling a worldwide health epidemic and a new level of competition in the obesity treatmentmarketplace.“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 leastone 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 justto Arena and to Eisai but to other companies in this space, given the signal that the FDA is opento approvals with appropriate measures. Competitors to Belviq wait in the wings, among themVivus’s Qnexa and Orexigen’s Contrave. The medical community eagerly awaits new therapiesbut safety concerns remain. Earlier-stage drugs from small companies act on novel mechanismsof action and might prove to be a safer and more efficacious approach to obesity. Clinical trialswill have to explore the possibilities.According to a favorable FDA panel decision earlier in 2012, previously voiced fears aboutcardiovascular and cancer risks were unfounded but more study was needed. Prior to the FDAdecision, Arena had agreed to conduct a postmarketing safety study in obese pediatric patientsand overweight or obese patients with cardiovascular disease or cardiovascular risk factors. Theapproval comes with this caveat: “The safety and efficacy of coadministration of BELVIQ withother products intended for weight loss and the effect of BELVIQ on cardiovascular morbidityand mortality have not been established.” Further, Belviq will be considered a scheduledsubstance.This decision is also one piece of a multifaceted push to address the intertwined problems ofmetabolic disorders, cardiovascular disorders, and other major contributors to costly morbidityand 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 majorpublic health concern,” Woodcock said.© 2012, Medmeme LLC. | +1 212-725-5992 | info@medmeme.com | www.medmeme.com
    • 2 Trendsmeme™ | White PaperIn the wake of the approval, Seeking Alpha quoted the U.S. market potential for obesity therapiesat $60.9 billion and predicted that Arena could net $300-500 million of it annually. On Belviq’sapproval, Arena shares have increased by 30%, according to Seeking Alpha.Many analysts peg Vivus’s Qnexa, a combination phentermine/topiramate drug, as the emergingobesity therapy most likely to succeed clinically and commercially. Data show that its weight-losseffects are greater than those achieved by rivals Belviq and Contrave—Qnexa promises to yield10% weight loss on average versus 3.1% for Belviq. Qnexa stimulates norepinephrine release tosuppress hunger with the low dose of phentermine and induces weight loss with a low dose oftopiramate via an unknown mechanism. The FDA is scheduled to make a decision on Qnexa onJuly 17, 2012. Indeed, conference presentation and journal publications titles in the Medmemedatabase 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 2011Note: 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-Phenanti-obesity combination that failed spectacularly in the 1980s. So, there is anticipation thatcardiac 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 toreports, obese patients undergoing bariatric surgery are not only achieving and sustaining© 2012, Medmeme LLC. | +1 212-725-5992 | info@medmeme.com | www.medmeme.com
    • 3 Trendsmeme™ | White Paperweight loss but also managing to decrease the dose of their type 2 diabetes medications, oreliminate 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 2011Source: Medmeme LLC. © Medmeme LLC. 2012Safety concerns, of course, are an issue for all obesity drugs, given the history of adversereactions, drug withdrawals, litigation, and a strict regulatory environment in this area. Thiswill be an area to watch as Belviq and, potentially, its competitors are rolled out onto themarketplace.© 2012, Medmeme LLC. | +1 212-725-5992 | info@medmeme.com | www.medmeme.com
    • 4 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.© 2012, Medmeme LLC. | +1 212-725-5992 | info@medmeme.com | www.medmeme.com
    • 5 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