Arena, Eisai collaborate in response to FDA's lorcaserin Complete Response Letter

Arena Pharmaceuticals, Inc.Jan 4 2012

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today that Arena has submitted its response to the Complete Response Letter (CRL) issued by the US Food and Drug Administration (FDA) following review of the lorcaserin New Drug Application (NDA). Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition. The companies expect that later this month the FDA will confirm acceptance of the response and assign a new Prescription Drug User Fee Act (PDUFA) date.

"We have worked diligently with Eisai to prepare this submission that we believe will address the issues raised in the complete response letter," said Jack Lief, Arena's President and Chief Executive Officer. "We look forward to providing on today's call an overview of the submission contents, including the results of the recently completed rat mechanistic studies, which we believe provide additional data supporting lorcaserin's benefit-risk profile."

Lonnel Coats, President and Chief Executive Officer of Eisai Inc., said, "Weight loss for obese patients and overweight patients with co-morbid conditions remains an area of unmet need. Eisai is pleased to collaborate with Arena in its response to the FDA, an important milestone toward lorcaserin's potential approval."

The response to the lorcaserin CRL includes data and analyses that were not incorporated in the original NDA, including the results of Arena's Phase 3 BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) clinical trial, which evaluated lorcaserin for weight loss in patients with type 2 diabetes. The new information also includes data and analyses from activities intended to address tumors observed in a two-year lorcaserin rat carcinogenicity study, cell culture experiments intended to further refine serotonin subtype 2 receptor activity and rat studies designed to further assess abuse potential. It is important to note that the FDA may analyze or weigh the data differently than Arena and Eisai.