WOODCLIFF LAKE, N.J. and SAN DIEGO, July 30, 2014 /PRNewswire/ -- Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that an article based on post-hoc analyses from the three pivotal Phase 3 trials of lorcaserin entitled, "Early Weight Loss While on Lorcaserin, Diet, and Exercise as a Predictor of Week 52 Weight-Loss Outcomes," was recently published in the online issue of Obesity, the official peer reviewed journal of The Obesity Society. The objective of these analyses was to identify whether there is an early treatment milestone that can predict greater than or equal to 5% weight loss at one year in patients treated with lorcaserin.
About BELVIQ® (lorcaserin HCl) CIVBELVIQ is a serotonin 2C receptor agonist approved in the United States as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition, such as high blood pressure, high cholesterol, or type 2 diabetes. The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss, including prescription drugs (e.g., phentermine), over-the-counter drugs, and herbal preparations, have not been established. The effect of BELVIQ on cardiovascular morbidity and mortality has not been established.
BELVIQ is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action of BELVIQ is not known.
BELVIQ is approved by the US Food and Drug Administration (FDA). Eisai markets and distributes BELVIQ in the United States, and Arena manufactures and supplies the finished commercial product from its facility in Switzerland.
Important Safety InformationContraindication
Warnings and Precautions
Most Common Adverse Reactions
BELVIQ® is a federally controlled substance that may lead to abuse or dependence.
About Eisai Inc. At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the US pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at http://us.eisai.com.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
About Arena PharmaceuticalsArena is embracing the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena is focused on discovering, developing and commercializing additional drugs to address unmet medical needs. Arena's US operations are located in San Diego, California, and its operations outside of the United States, including its commercial manufacturing facility, are located in Zofingen, Switzerland. For more information, visit Arena's website at www.arenapharm.com.
Arena has granted exclusive marketing and distribution rights for BELVIQ to Eisai Inc. and Eisai Co., Ltd., for the United States and most other territories worldwide.
Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.
Forward-Looking StatementsCertain 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 therapeutic indication, use, safety, efficacy, mechanism of action, and potential of BELVIQ or lorcaserin; the significance of the post-hoc analyses and their results; rights and obligations under the marketing and supply agreement among Arena and Eisai; embracing the challenge of improving health; seeking to bring innovative medicines to patients; and Arena's focus, plans, goals, strategy, expectations, research and development programs, and ability to discover and 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 Arena's actual results to differ materially from the forward-looking statements include, but are not limited to, the following: risks related to commercializing drugs, including regulatory, manufacturing, supply and marketing issues and the availability and use of BELVIQ; cash and revenues generated from BELVIQ, including the impact of competition; Arena's revenues will be based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena's guidance or previously reported results; the timing and outcome of regulatory review is uncertain, and BELVIQ may not be approved for marketing when expected or ever in combination with another drug, for another indication or using a different formulation or in any other territory for any indication; regulatory decisions in one territory may impact other regulatory decisions and Arena's business prospects; government and commercial reimbursement and pricing decisions; risks related to relying on collaborative arrangements; the timing and receipt of payments and fees, if any, from collaborators; the entry into or modification or termination of collaborative arrangements; 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 may not meet regulatory requirements or otherwise be sufficient for (or Arena or a collaborator may not pursue) further research and development, regulatory review or approval or continued marketing; Arena's ability to obtain and defend patents; the timing, success and cost of Arena's research and development; 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.Contacts: Eisai Inc. Investor Inquiries:
Media Inquiries: Alex Scott
Laurie Landau firstname.lastname@example.org
201.746.2510Contact: Arena Pharmaceuticals, Inc. Craig M. Audet, Ph.D., Senior Vice President,
David Schull, PresidentOperations and Head of Global Regulatory Affairs
858.717.2310858.453.7200, ext. 1612
|SOURCE Arena Pharmaceuticals, Inc.|
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