SAN DIEGO, Oct. 12, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. announced today that lorcaserin will be featured in multiple presentations at Obesity 2009, the 27th Annual Scientific Meeting of The Obesity Society in Washington, DC.
The line-up includes a late-breaking abstract oral presentation of results from BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), a Phase 3 trial for which Arena reported positive, highly significant top-line results in September. Arena will also present new data analyses from lorcaserin’s successful Phase 3 pivotal program in oral and poster sessions. In an independent clinical symposium, expert academic scientists and physicians will spotlight the 5HT-2C mechanism for weight management.
The positive results from our Phase 3 pivotal program highlight lorcaserin’s potential to provide physicians with a treatment option that combines three important attributes - efficacy, safety and tolerability
"- critical to broad applicability in the majority of their patients to help manage weight and improve cardiometabolic health,” stated William R. Shanahan, M.D., Arena’s Vice President and Chief Medical Officer. “The breadth of presentations featuring lorcaserin at The Obesity Society’s annual scientific meeting speaks to the strong interest physicians have in this drug candidate.”
Obesity 2009: Presentation Schedule
Phase 3 Program Overview
The lorcaserin Phase 3 program consists of three trials: BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), BLOSSOM and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus). Enrollment in the lorcaserin Phase 3 program is complete with approximately 7,800 patients. Positive results from BLOOM were presented at the 69th Scientific Sessions of the American Diabetes Association in June 2009 and positive top-line results from BLOSSOM were reported in September 2009. BLOOM and BLOSSOM comprise the Phase 3 pivotal registration program and will be the basis for the lorcaserin NDA submission. BLOOM-DM, which is planned as a supplement to the NDA, is evaluating 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes at about 60 sites in the US.
A standardized program of moderate diet and exercise guidance is included in the Phase 3 program. The program’s hierarchically ordered co-primary efficacy endpoints are: the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. Arena is also studying several key secondary endpoints, including changes in serum lipids, markers of inflammation and insulin resistance, and in the BLOOM-DM trial, other indicators of glycemic control.
About Lorcaserin
Lorcaserin is a novel single agent that represents the first in a new class of selective 5HT-2C receptor agonists. The 5HT-2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena’s most advanced drug candidate, lorcaserin, is being investigated in a Phase 3 clinical trial program for weight management. Arena has a broad pipeline of novel compounds targeting G protein-coupled receptors, an important class of validated drug targets, which includes compounds being evaluated independently and with partners, including Merck & Co., Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company. “APD” is an abbreviation for Arena Pharmaceuticals Development.
Forward-Looking Statements
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 significance of the lorcaserin results and the success of the lorcaserin Phase 3 program; lorcaserin’s commercial and other potential; the importance of efficacy, safety and tolerability and the combination of such attributes; interest in lorcaserin; the development, advancement, therapeutic indication, tolerability, safety, selectivity and efficacy of lorcaserin; the protocol, design, scope, enrollment and other aspects of the lorcaserin trials; the Phase 3 pivotal registration program; the potential of the lorcaserin Phase 3 program and its results to satisfy the FDA’s approval requirements; future activities, results and announcements relating to lorcaserin, including submitting an NDA for lorcaserin and the BLOOM-DM results as a supplement to the NDA; lorcaserin’s patent coverage; and Arena’s strategy, internal and partnered 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 timing, success and cost of Arena’s lorcaserin program and other of its research and development programs; results of clinical trials or preclinical studies may not be predictive of future results; clinical trials and studies may not proceed at the time or in the manner Arena expects or at all; Arena’s ability to partner or commercialize lorcaserin or other of its compounds or programs; the timing and ability of Arena to receive regulatory approval for its drug candidates; Arena’s ability to obtain additional funds; Arena’s ability to obtain and defend its patents; and the timing and receipt of payments and fees, if any, from Arena’s collaborators. 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.
SOURCE Arena Pharmaceuticals, Inc.
CONTACT: Jack Lief, President and CEO, or Cindy McGee, Manager, IR and
Corporate Communications, +1-858-453-7200, ext. 1479, both of Arena
Pharmaceuticals, Inc.; or Media, David Schull, President, +1-858-717-2310,
david.schull@russopartnersllc.com, or Anthony J. Russo, Ph.D., CEO,
+1-212-845-4251, tony.russo@russopartnersllc.com, both of Russo Partners,
for Arena Pharmaceuticals, Inc.
Web site: http://www.arenapharm.com/
