SAN DIEGO, Dec. 9 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. today announced preliminary data from a Phase 2b clinical trial of APD125 measuring subjective endpoints in patients with primary insomnia. The initial data analysis indicates that APD125 did not meet the trial’s primary or secondary endpoints. Treatment with APD125 was well tolerated, and there were no reports of serious adverse events and no emerging safety findings as compared to placebo. Arena is finishing a complete analysis of the data, but does not anticipate any further development of APD125.
“While we are disappointed and anticipated a different result based on objective polysomnographic results from our previous studies, our priority remains the successful development of lorcaserin, our proprietary investigative treatment for obesity. We expect to announce lorcaserin results from BLOOM, our first pivotal Phase 3 clinical trial, around the end of March and to file a New Drug Application for lorcaserin by the end of 2009,” said Jack Lief, Arena’s President and Chief Executive Officer. “We look forward to the opportunity to review our lorcaserin program, as well as other programs, at our upcoming R&D Day on December 15.”
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 the treatment of obesity. Arena’s broad pipeline of novel compounds target G protein-coupled receptors, an important class of validated drug targets, and includes compounds being evaluated independently and with partners, including Merck & Co., Inc. and Ortho-McNeil Pharmaceutical, Inc.
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 results of the Phase 2b clinical trial of APD125, including the significance of such results; the further analysis of the Phase 2b clinical trial results and the future development of APD125; the development, therapeutic indication, tolerability, side effects, efficacy and potential of lorcaserin; future activities and announcements relating to lorcaserin, including the BLOOM results and the submission of a New Drug Application for lorcaserin; Arena’s R&D Day; and about 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, clinical trials and studies may not proceed at the time or in the manner Arena expects or at all, the results of clinical trials or preclinical studies may not be predictive of future results, Arena’s ability to receive regulatory approval for its drug candidates, Arena’s ability to partner lorcaserin or other of its compounds or programs, the timing, success and cost of Arena’s research, out-licensing endeavors and clinical trials, Arena’s ability to obtain additional financing, 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.
CONTACT: Jack Lief, President and CEO, or David Walsey, Senior Director,
Corporate Communications, both of Arena Pharmaceuticals, Inc.,
+1-858-453-7200, ext. 1682; or Julie Normart of WeissComm Partners Media
Relations, +1-415-946-1087, for Arena Pharmaceuticals, Inc.
Web site: http://www.arenapharm.com/
