Orexigen Therapeutics to Present Data on Contrave and Empatic at The Obesity Society's 2007 Annual Scientific MeetingSAN DIEGO--(BUSINESS WIRE)--Oct 18, 2007 - Orexigen(TM) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders including obesity, today announced that the Company will be presenting data on its two product candidates for the treatment of obesity, Contrave(TM) and Empatic(TM), in five sessions at The Obesity Society's Annual Scientific Meeting (NAASO) in New Orleans, October 20-24, 2007.
"We are pleased to have five presentations at this very prestigious obesity meeting. This forum enables us to showcase some of Orexigen's recent work from both our clinical and laboratory scientists," said Gary Tollefson, M.D., Ph.D., Orexigen President and CEO. "We believe the data being presented supports what we believe to be the critical role played by the brain in obesity as it regulates what, why, when, and how much we eat."
Orexigen's presentations are as follows: Saturday, October 20th Session Title: Pre-Conference Session - New Developments in Obesity Pharmacotherapy Presentation Time: 2:45 - 3:10pm Presenter: Gary D. Tollefson M.D., Ph.D., President and CEO, Orexigen Therapeutics, Inc. Title: CNS Approaches Targeting Compensatory Weight Loss Mechanisms: Clinical Experience with Contrave and Empatic in Appetite, Energy and Behavioral Regulation Sunday, October 21st Session Title: Dedicated Poster Abstract Viewing Session Presentation Time: 5:00 - 6:30pm Presenter: Frank Greenway, M.D., Prof, Chief Outpatient Clinic, Pennington Biomedical Research Center Title: A Double-Blind, Placebo-, Bupropion- and Naltrexone-Controlled Study of the Efficacy and Safety of 3 Doses of Naltrexone-Bupropion SR Combination Therapy in Obesity: Effects on Total and Visceral Adipose Tissue and CV Risk Markers. (#269-P) Session Title: Dedicated Poster Abstract Viewing Session Presentation Time: 5:00 - 6:30pm Presenter: Ken Fujioka, M.D., Director, Nutrition and Metabolic Research Center, Scripps Title: The 24 Week Experience with a Combination Sustained Release Product of Zonisamide and Bupropion: Evidence of an Encouraging Benefit:Risk Profile (#270-P) Tuesday, October 23rd Session Title: Dedicated Poster Abstract Viewing Session Presentation Time: 1:00-2:30 pm Presenter: Michael Cowley, Ph.D., Chief Scientific Officer, Orexigen Therapeutics, Inc. Title: Bupropion and Naltrexone Interact Synergistically to Decrease Food Intake in Mice (#567-P) Wednesday, October 24th Session Title: Oral Abstract Presentation - Clinical Studies Presentation Time: 9:15 - 9:30am Presenter: Eduardo Dunayevich, M.D., Chief Medical Officer, Orexigen Therapeutics, Inc. Title: A Double-Blind, Placebo-, Bupropion-, Naltrexone-Controlled Study of the Efficacy and Safety of 3 Doses of Combined Naltrexone IR-Bupropion SR Therapy in Obesity: 24 and 48 Week Data
Contrave employs a proprietary formulation of two CNS molecules, bupropion and naltrexone, that have been independently approved by the US Food and Drug Administration in other indications. Orexigen chose these two constituent drugs based on the results of a proprietary screening model and the Company's understanding of circuitries in the brain that regulate appetite and energy balance. Empatic employs a proprietary formulation of two CNS molecules, bupropion and zonisamide, that have been independently approved by the US Food and Drug Administration in other indications. Orexigen developed its own proprietary SR version of zonisamide to improve drug tolerability. Bupropion and zonisamide each target reciprocal pathways in the hypothalamus that mediate appetite and energy expenditure. The unique combinations of both Contrave and Empatic are designed to provide more clinically meaningful weight loss for patients by both initiating weight loss and sustaining it over a longer period.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the development of pharmaceutical product candidates for the treatment of central nervous system disorders including obesity. Orexigen's lead combination product candidates targeted for obesity are Contrave, which is in Phase III clinical trials, and Empatic, which is in the later stages of Phase II development. Both product candidates are designed to take advantage of the Company's understanding of how the brain appears to regulate appetite and energy expenditure, as well as the mechanisms that come into play to limit weight loss over time. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss. Further information about the Company can be found at http://www.Orexigen.com.
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on Orexigen's current beliefs and expectations. These forward-looking statements include statements regarding the efficacy and safety of the various formulations of Contrave or Empatic, and the potential to obtain regulatory approval for, and effectively treat obesity with, any of Orexigen's product candidates. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in Orexigen's business, including, without limitation: the progress and timing of Orexigen's clinical trials; the potential that earlier clinical trials may not be predictive of future results; the ability for Contrave or Empatic to receive regulatory approval on a timely basis or at all; the potential for adverse safety findings relating to Empatic or Contrave to delay or prevent regulatory approval or commercialization, or result in product liability claims; Orexigen and its licensors may not be able to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates; and other risks described in Orexigen's filings with the Securities and Exchange Commission (SEC), including those detailed under the heading "Risk Factors" in Orexigen's Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 filed with the SEC on August 10, 2007. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Graham Cooper, 858-436-8600
Stephen Gendel, 212-918-4640
Jason Spark, 619-849-6005
Posted: October 2007