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Upon issuance, the patent will broadly cover methods of treating obesitywith combinations of bupropion and naltrexone, the two active agents inContrave. It is a companion to the Weber/Cowley composition patent (U.S.7,375,111) which was issued by the USPTO in May 2008, which broadly coverssustained release (SR) compositions of bupropion and naltrexone combined in asingle dosage form. It is anticipated that the Weber/Cowley methods patentwill provide protection for Contrave through mid 2024.
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"This patent represents another successful milestone for Orexigen. Uponissuance, Contrave would be protected by four patents that collectively willprovide broad intellectual property coverage," said Orexigen President andCEO, Gary Tollefson, M.D., Ph.D. "With this additional patent allowance, wehave added another layer of protection in support of Contrave which we believeenhances its net present value."
Contrave is an investigational weight loss medication with a mechanism ofaction that works at two sites within the central nervous system. The firstis a hypothalamic site that controls the balance of food intake andmetabolism. We believe that Contrave is possibly the first treatment forobesity to address a second site, the reward systems in the brain that areassociated with food preference and food cravings. In clinical trials,Contrave has initiated and sustained significant weight loss over one year oftreatment (approximately 8-10.7% in patients completing 48 weeks of therapy)we believe by reducing appetite, increasing metabolism and offsetting thebody's natural tendency to fight back and slow down the weight loss process.We expect to announce data from the first of our Contrave Phase 3 trials inJanuary of 2009 and the remaining three trials by mid next year.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on thetreatment of obesity and other central nervous system-related disorders. TheCompany's lead combination product candidates targeted for obesity areContrave, which is in Phase 3 clinical trials, and Empatic(TM), which is inthe later stages of Phase 2 clinical development. Each product candidate isdesigned to act on a specific group of neurons in the central nervous systemwith the goal of achieving appetite suppression and sustained weight loss.Beyond obesity, Orexigen is developing drug combinations for use inschizophrenia and obsessive-compulsive disorder. Further information aboutthe company can be found at http://www.Orexigen.com.
Orexigen cautions you that statements included in this press release thatare not a description of historical facts are forward-looking statements.Words such as "believes," "anticipates," "plans," "expects," "indicates,""will," "intends," "potential," "suggests," "assuming," "designed," "projects"and similar expressions are intended to identify forward-looking statements.These statements are based on the Company's current beliefs and expectations.These forward-looking statements include statements regarding enrollment,timing, execution and completion of clinical trials of Contrave, the timing ofan NDA submission with the FDA for Contrave, the efficacy and safety ofContrave, the potential to obtain regulatory approval for, and effectivelytreat obesity with, Contrave, and the potential issuance of patents and thescope and duration of protection of issued patents relating to the Company'sproduct candidates. The inclusion of forward-looking statements should not beregarded as a representation by Orexigen that any of its plans will beachieved. Actual results may differ from those set forth in this release dueto the risk and uncertainties inherent in the Company's business, including,without limitation: the progress and timing of the Company's Contrave clinicaltrials or the development of Contrave; the potential that earlier clinicaltrials may not be predictive of future results; the potential for adversesafety findings relating to Contrave to delay or prevent regulatory approvalor commercialization, or result in product liability claims; Orexigen or itslicensors may not be able to obtain, maintain and successfully enforceadequate patent and other intellectual property protection of its productcandidates; and other risks described in the Company's filings with theSecurities and Exchange Commission (SEC). You are cautioned not to place unduereliance on these forward-looking statements, which speak only as of the datehereof, and Orexigen undertakes no obligation to revise or update this newsrelease to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionarystatement. This caution is made under the safe harbor provisions of Section21E of the Private Securities Litigation Reform Act of 1995.
SOURCE Orexigen Therapeutics, Inc.
