SAN DIEGO, Dec. 12 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. announced today that their lead compound for the treatment of obesity, APD356, won San Diego based CONNECT’s Most Innovative New Product (“MIP”) Award in the Biotechnology Research and Development category. APD356 is a selective agonist of 5-HT2C serotonin receptors, which are located in the hypothalamus, an area of the brain that plays an important role in regulating food intake and metabolism. In a Phase 2a clinical trial, APD356 demonstrated a highly statistically significant (p=.0002) average weight loss of 2.9 pounds in patients taking the 15 mg dose of APD356 versus 0.9 pounds for the placebo group, and was generally well tolerated at all doses investigated. Top-line data from Arena’s Phase 2b clinical trial evaluating weight loss in 469 obese patients taking APD356 over 12 weeks are expected soon.
The MIP Awards is an annual competition held by CONNECT, a San Diego based program linking high-technology and life science entrepreneurs with the resources they need for success. The competition honors the vision, hard work, and perseverance that transform ideas and technologies into products. This year marks the 18th anniversary of the Awards’ tradition of showcasing San Diego companies with cutting-edge high technology. A selection committee comprised of business executives, researchers and event sponsors reviewed all nominations and selected winners based on innovation and technology.
About Obesity
Obesity affects tens of millions of adults and children in the U.S. and poses a serious long-term threat to their health and welfare. The number of overweight and obese people has substantially increased over the past several decades. Approximately two-thirds of all adults in the U.S. are obese or overweight. Medical and related costs of obesity in the U.S. were more than $117 billion in 2000. Being obese or overweight is associated with a number of conditions, including heart disease, stroke, diabetes, cancer and osteoarthritis. Medical treatment options for obese and overweight people are currently limited.
About APD356
APD356 is a selective agonist of 5-HT2C serotonin receptors, which are located in the hypothalamus, an area of the brain that plays an important role in regulating food intake and metabolism. Discovered by Arena, APD356 is intended to selectively stimulate the 5-HT2C receptor and has approximately 100-fold selectivity in vitro for the 5-HT2C receptor relative to the 5-HT2B receptor. It is hypothesized that activation of the 5-HT2B receptor is associated with the cardiac valvulopathy observed with non-selective serotonergic agents. In addition, APD356 has approximately 15-fold selectivity in vitro for the 5-HT2C receptor versus the 5-HT2A receptor. Arena believes that the 5-HT2A receptor contributes to the potential central nervous system adverse effects associated with non-selective serotonergic agents. Arena expects that the selectivity of APD356 may allow the compound to be dosed at a well-tolerated level that will induce clinically relevant weight loss without the cardiac valvular side effects observed with non-selective serotonergic agents previously used in the treatment of obesity.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focusing on the discovery, development and commercialization of small molecule drugs in four major therapeutic areas: metabolic, cardiovascular, inflammatory and central nervous system diseases. Arena is developing a broad pipeline of compounds that act on an important class of drug targets called G protein-coupled receptors, or GPCRs, using its knowledge of GPCRs and its technologies, including CART(TM) (Constitutively Activated Receptor Technology) and Melanophore. Arena has three internally discovered, clinical-stage product candidates. Arena’s most advanced clinical compound, APD356, a selective 5-HT2C serotonin receptor agonist for the treatment of obesity, is in Phase 2b. Arena’s lead product candidate for the treatment of insomnia, APD125, a compound with a novel mechanism of action (a selective 5-HT2A receptor inverse agonist), is scheduled to begin a Phase 2 clinical trial by the end of 2005. As part of Arena’s collaboration with Merck & Co., Inc., an Arena product candidate for the treatment of atherosclerosis and related disorders is in a Phase 1 clinical trial. Arena also has an active collaboration with Ortho-McNeil, Inc., a Johnson & Johnson company, for the treatment of type 2 diabetes.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company. CART(TM) is an unregistered service mark of the company.
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 expected timing and results of Arena’s Phase 2 clinical trial of APD356, the timing of Arena’s Phase 2 clinical trial of APD125 and other statements about Arena’s strategy, technologies, preclinical and clinical 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 results of Arena’s clinical trials, the results of preclinical studies or clinical trials may not be predictive of future results, Arena’s ability to partner APD356, APD125 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, Arena’s patent protection, and the timing and receipt of payments and fees, if any, from Arena’s collaborators, including Ortho-McNeil and Merck. 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.
Contacts: Jack Lief Carin Canale President and CEO Atkins + Associates Media & Investor Relations David Walsey (858) 336-3027 Director, Corporate Communications Arena Pharmaceuticals (858) 453-7200, Ext. 1682 www.arenapharm.com
Arena Pharmaceuticals, Inc.
CONTACT: Jack Lief, President and CEO, or David Walsey, Director,Corporate Communications, both of Arena Pharmaceuticals, +1-858-453-7200,Ext. 1682; or Media & Investor Relations, Carin Canale of Atkins +Associates, +1-858-336-3027, for Arena Pharmaceuticals, Inc.
Web site: http://www.arenapharm.com/
