7/12/2012 8:37:46 AM
SAN DIEGO, July 11, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the filing with the Swiss health authority, Swissmedic, of a Marketing Authorization Application (MAA) for lorcaserin hydrochloride, an investigational drug candidate in Switzerland. The intended indication is as an adjunct to diet and exercise for weight control in patients with an initial body mass index (BMI) of 30 kg/m(2) or greater (obese), or 27 kg/m(2) or greater (overweight) in the presence of at least one weight related comorbid condition. Arena expects that Swissmedic will accept the filing later this month and confirm the filing is sufficiently complete to permit a substantive review process.
"This submission reflects our continued efforts to make lorcaserin available to physicians and patients beyond the United States," said Jack Lief, Arena's President and Chief Executive Officer. "We look forward to Swissmedic's review of our application and to the potential approval of lorcaserin in Switzerland for patients who are obese or overweight with comorbidities."
As part of the Swiss MAA, Arena submitted data from its three double-blind, randomized, placebo-controlled clinical trials, which demonstrated that lorcaserin along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after one year and managing the weight loss for up to two years. In these trials, the most common adverse reactions for patients without diabetes treated with lorcaserin were headache, dizziness, fatigue, nausea, dry mouth, and constipation. In patients with diabetes, the most common adverse reactions were hypoglycemia, headache, back pain, cough, and fatigue.
The MAA filing in Switzerland is the third marketing application submitted to date for lorcaserin. Lorcaserin was approved by the US Food and Drug Administration (FDA) under the trade name BELVIQ in June 2012, and is currently under review with the European Medicines Agency (EMA). Switzerland is not part of the EMA and requires an independent application and approval from Swissmedic.
Lorcaserin is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. Activation of these receptors may help a person eat less and feel full after eating smaller amounts of food. Arena has patents or patent applications that cover lorcaserin in the United States, Europe, Canada, Mexico, Brazil and many other jurisdictions that, if issued, in most cases would be capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
About Arena Pharmaceuticals
Arena Pharmaceuticals, Inc., is a 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. For more information about Arena, please visit www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc.
BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.
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 lorcaserin's (or BELVIQ's) safety, efficacy, mechanism of action and intended indication; Swissmedic's acceptance and review of the lorcaserin MAA; the potential approval of lorcaserin; lorcaserin's patents; and Arena's efforts, 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 and outcome of DEA, EMA, Swissmedic and other regulatory review is uncertain; limitations on the indicated uses, distribution, marketing and other limitations on BELVIQ or, if approved, any of Arena's other drug candidates; risks related to commercializing drugs, including regulatory, manufacturing and supply issues and the pace of market acceptance; cash and revenues generated from BELVIQ, including timing and impact of competition; government and commercial reimbursement and pricing decisions; risks related to relying on collaborative agreements; the timing and receipt of payments and fees, if any, from collaborators; unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; data and other information related to any of Arena's research and development programs may not meet safety, efficacy or other regulatory requirements or otherwise be sufficient for regulatory review, approval or continued marketing; Arena's ability to obtain and defend 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; having adequate funds; and satisfactory resolution of 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.
SOURCE Arena Pharmaceuticals, Inc.