Arena Pharmaceuticals Files European Marketing Authorization Application for Lorcaserin for Weight Control
SAN DIEGO, March 2, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for lorcaserin, an investigational drug candidate intended for weight control, 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. Arena expects the EMA will accept the filing later this month and confirm the filing is sufficiently complete to permit a substantive review.
"With rates of obesity tripling in many European countries over the last thirty years, there is a substantial unmet need for new treatments to manage weight," said Jack Lief, Arena's President and Chief Executive Officer. "We look forward to working with the EMA and our Rapporteur and Co-rapporteur during this centralized review process and to the potential approval of lorcaserin in E.U. member countries."
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, major European countries 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 resubmitted to the U.S. Food and Drug Administration (FDA) the lorcaserin New Drug Application (NDA) in December 2011, and the agency assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012. Eisai Inc. has exclusive rights to market and distribute lorcaserin in the United States subject to FDA approval of the lorcaserin NDA. Arena currently owns rights to lorcaserin outside of the United States.
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 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, mechanism of action, and potential of lorcaserin; the regulatory review of the lorcaserin MAA submission and NDA resubmission, including the EMA's acceptance and review of the MAA and the timing for the FDA to complete its review of the NDA resubmission; working with the EMA and the Rapporteur and Co-rapporteur; the potential approval and commercialization of lorcaserin; the Eisai collaboration and potential activities thereunder; need for new treatments to manage weight; 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: Arena's MAA submission for regulatory approval of lorcaserin may not be accepted or reviewed, when anticipated, if at all; the timing of regulatory review and approval is uncertain, and the FDA may not complete its review of the lorcaserin NDA resubmission by the PDUFA date; the occurrence, timing and results of FDA advisory committee meetings relating to lorcaserin and other drug candidates; 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 lorcaserin and Arena's other research and development programs may not meet safety, efficacy or other regulatory requirements or otherwise be sufficient for regulatory review or approval; 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; having 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.
Editor's Note: Photograph of lorcaserin tablets available with news release
Arena Pharmaceuticals, Inc.
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SOURCE Arena Pharmaceuticals, Inc.