SAN DIEGO, May 20, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that lorcaserin will be featured in presentations at ECO 2011, the 18th European Congress on Obesity. ECO 2011 will take place May 25-28, 2011, at the Istanbul Convention & Exhibition Centre Lutfi Kirdar in Istanbul, Turkey. The presentations will include meta-analyses of the three trials in the lorcaserin Phase 3 clinical trial program.
Thursday, May 26
Hot Topic Poster: Evaluation of Lorcaserin, a Selective Serotonin 2C Agonist for Weight Management: Integrated Clinical Trial Results for 7,500 Patients
The poster, number HTP.019, will be featured on a guided tour during the Hot Topic Posters session on May 26 from 1:00 p.m. to 3:00 p.m. Eastern European Summer Time (EEST). The poster will be on display in the Exhibition Hall from May 25 at 3:00 p.m. EEST to May 28 at 2:00 p.m. EEST.
Friday, May 27
European Association for the Study of Obesity/Industry Drug Update Session: Lorcaserin, a Novel 5-HT2C Agonist for Weight Management
Session Time: 5:30 p.m. to 7:00 p.m. EEST
Christen M. Anderson, M.D., Ph.D., Arena's Vice President, Lorcaserin Development, is scheduled to present from 6:30 p.m. to 6:45 p.m. EEST in the Main Auditorium.
Lorcaserin is an investigational drug candidate intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition. Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
Arena submitted a New Drug Application (NDA) for lorcaserin to the US Food and Drug Administration (FDA) in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. Arena is engaged in activities to address the issues raised by the FDA as part of its plan to submit a response to the CRL.
Lorcaserin Phase 3 Clinical Trial Program Overview
The lorcaserin Phase 3 clinical trial program consists of three double-blind, randomized, placebo-controlled trials, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus), and enrolled approximately 7,800 patients. BLOOM and BLOSSOM evaluated lorcaserin versus placebo in patients who are obese or patients who are overweight and have at least one weight-related co-morbid condition. BLOOM evaluated 3,182 patients over a two-year treatment period, and BLOSSOM evaluated 4,008 patients over a one-year treatment period. BLOOM-DM evaluated 604 obese and overweight patients with type 2 diabetes over a one-year treatment period. The trials included a standardized program of moderate diet and exercise guidance.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is intended for weight management. Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States subject to FDA approval of the NDA for lorcaserin.
Arena Pharmaceuticals® and Arena® are registered service marks of the company.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the advancement, therapeutic indication and use, safety, efficacy, tolerability and mechanism of action of lorcaserin; the response to the CRL for the lorcaserin NDA, including related plans and activities; the Eisai collaboration and potential activities thereunder; lorcaserin's patent coverage; and Arena's focus, goals, strategy, research and development programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: the timing of regulatory review and approval is uncertain; the risk that data and other information related to Arena's research and development programs, including for lorcaserin, may not meet safety or efficacy requirements or otherwise be sufficient for regulatory approval; Arena's response to the CRL for the lorcaserin NDA may not be submitted when anticipated, if at all; the FDA may request other information prior to or after Arena submits such response or approval of the lorcaserin NDA; unexpected or unfavorable new data; risks related to commercializing new products; Arena's ability to obtain and defend its patents; the timing, success and cost of Arena's research and development programs; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; Arena's ability to obtain adequate funds; risks related to relying on collaborative agreements; the timing and receipt of payments and fees, if any, from collaborators; and satisfactory resolution of pending and any future litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Contact: Arena Pharmaceuticals, Inc.
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David Schull, President
President and CEO
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Anthony J. Russo, Ph.D., CEO
858.453.7200, ext. 1479
SOURCE Arena Pharmaceuticals, Inc.