Arena Submits Response to FDA Complete Response Letter for Lorcaserin
-- Arena to Host Conference Call Today at 5:30 p.m. Eastern Time --
SAN DIEGO and WOODCLIFF LAKE, N.J., Jan. 3, 2012 /PRNewswire/ -- 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.
Conference Call and Webcast
Arena will host a conference call and webcast to discuss the response to the lorcaserin CRL, including results from the studies conducted to investigate the mechanism underlying mammary tumors that were observed in female rats, at 5:30 p.m. Eastern Time (2:30 p.m. Pacific Time) today. An overview of the results from the rat mechanistic studies is also available in a Form 8-K that Arena filed today with the Securities and Exchange Commission.
The conference call may be accessed by dialing 877.643.7155 for domestic callers and 914.495.8552 for international callers. Please specify to the operator that you would like to join the "Arena Pharmaceuticals' Lorcaserin Conference Call." The conference call will be webcast live under the investor relations section of Arena's website at www.arenapharm.com and will be archived there for 30 days following the call. Please connect to Arena's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
Lorcaserin is an investigational drug candidate intended for weight management, 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. 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 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 submitted the original NDA for lorcaserin in December 2009, and the FDA issued a CRL in October 2010. Arena submitted a response to the lorcaserin CRL in December 2011, and it expects that in January 2012 the FDA will assign a new PDUFA date. Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States subject to FDA approval of the lorcaserin NDA.
Lorcaserin Phase 3 Clinical Trial Program Overview
The lorcaserin Phase 3 clinical trial program consists of three double-blind, randomized, placebo-controlled trials, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) and BLOOM-DM, and enrolled approximately 7,800 patients. BLOOM and BLOSSOM evaluated lorcaserin versus placebo in patients who are obese or patients who are overweight and have at least one weight-related co-morbid condition. BLOOM evaluated 3,182 patients over a two-year treatment period, and BLOSSOM evaluated 4,008 patients over a one-year treatment period. BLOOM-DM evaluated 604 obese and overweight patients with type 2 diabetes over a one-year treatment period. The trials included a standardized program of moderate diet and exercise guidance.
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.
About Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-25 US pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the US pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes US-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/us.
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, tolerability, mechanism of action, benefit-risk profile and potential of lorcaserin; the response to the CRL for the lorcaserin NDA, including its significance, confirmation of acceptance, assignment of a PDUFA date, the FDA's review and addressing issues raised in the CRL; the data and studies, analyses and other activities included in such response, including their significance and what they were intended to address, refine and assess; weight loss as an area of unmet need; the potential approval and commercialization of lorcaserin; the Eisai collaboration and potential activities thereunder; 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: the timing of regulatory review, including the assignment of a PDUFA date, and approval is uncertain; 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 or efficacy requirements or otherwise be sufficient for regulatory review or approval; Arena's submission of a marketing authorization application for regulatory approval of lorcaserin may not be submitted when anticipated, if at all; 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; Arena's ability to obtain 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.