Navigation Links
Arena Pharmaceuticals Files Marketing Authorization Application in Switzerland for Lorcaserin as a Treatment for Weight Control
Date:7/11/2012

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.

About Lorcaserin
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.

Forward-Looking Statements
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.Contacts: Arena Pharmaceuticals, Inc. 858.453.7200Investor Inquiries: Russo Partners

Media Inquiries: Russo PartnersCindy McGee

 David Schullcindy.mcgee@russopartnersllc.com

 david.schull@russopartnersllc.com619.213.6995

 858.717.2310 www.arenapharm.com


'/>"/>
SOURCE Arena Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Arena Pharmaceuticals Announces First Quarter 2012 Financial Results and Recent Developments
2. Arena Pharmaceuticals Announces Proposed Public Offering of Common Stock
3. Arena Pharmaceuticals Announces Exercise in Full of Over-Allotment Option and Completion of Public Offering of Common Stock
4. Aperture Health, Inc., Targeting the Strong Growth in the Long Term Disease Management arena
5. Arena Pharmaceuticals Promotes Craig M. Audet to Executive Officer as Senior Vice President, Operations and Head of Global Regulatory Affairs
6. Arena Pharmaceuticals to Present at the Seventh Annual JMP Securities Healthcare Conference
7. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
8. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
9. Nouveau Life Pharmaceuticals (HRID) Contracts with U.S. Manufacturer to Produce New Female Supplement
10. BioElectronics Survey Indicates a Five-Fold Superior Pain Relief Compared to OTC Pharmaceuticals
11. Icahn Issues Statement Regarding Amylin Pharmaceuticals
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... , Dec. 8, 2016 Australia Glaucoma ... GlobalData,s new report, "Australia Glaucoma Surgery Devices ... on the Australia Glaucoma Surgery Devices market. The ... volume (in units) and average prices (USD) within ... report also provides company shares and distribution shares ...
(Date:12/8/2016)... , Dec. 8, 2016 KEY FINDINGS ... poised to grow in 2017-2023. Various reasons for growth ... obese population, higher incidences of chronic diseases, high recovery ... mobility aid services. Medical lifting sling refers to ... with limited mobility. These slings connect to the lift ...
(Date:12/8/2016)... INDIANAPOLIS , Dec. 8, 2016  Eli Lilly ... detailed results of its phase 3 EXPEDITION3 trial at ... (CTAD) meeting. As previously disclosed, solanezumab did not meet ... study of solanezumab initiated in people with mild dementia ... pursue regulatory submissions for solanezumab for the treatment of ...
Breaking Medicine Technology:
(Date:12/9/2016)... (PRWEB) , ... December 09, 2016 , ... ... planning assistance from offices in Pasco and Richland, is initiating a charity drive ... serious injuries resulting from a recent automobile collision. , On October 29th ...
(Date:12/9/2016)... ... December 09, 2016 , ... "I have gout, and ... this old family recipe, which is meant to relieve gout and pain caused by ... a 12-hour energy boost every time. It relieved what VA doctors called the worst ...
(Date:12/9/2016)... ... December 09, 2016 , ... An inventor from Cana, Va., wanted ... all types of amusement park rides. , The patent-pending SAFETY STRAP FOR AMPUTEES improves ... use and could be set up in a matter of minutes, or even seconds. ...
(Date:12/9/2016)... ... December 09, 2016 , ... ... proudly announced today that a new solution for Emergency Departments (ED) has been ... tight space in Emergency Department examination rooms, and with a simplified pallet of ...
(Date:12/8/2016)... ... December 08, 2016 , ... The West Virginia Medical ... 2017. The name change aligns the entire company with its existing Quality ... quality. , “We are very proud of the achievements associated with the West ...
Breaking Medicine News(10 mins):