Orexigen(R) Therapeutics Announces Third Quarter 2008 Financi...(nitiated the second Phase 2b clinical tr...)

Date:11/6/2008

nitiated the second Phase 2b clinical trial of Empatic in July and completed enrollment earlier this month, ahead of schedule. The trial is designed to build on the safety and efficacy results from the previous Phase 2b trial of Empatic, ZB-201, which demonstrated robust weight loss at 48 weeks and a discontinuation rate due to adverse events that was not significantly different than placebo. The Company expects the results of this the second Phase 2b clinical trial, ZB-202, to be available in the second quarter of 2009.

-- Orexigen received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for what the Company refers to as the "Weber/Cowley methods patent" (U.S. patent application no. 11/356,839). Upon issuance, the patent will broadly cover methods of treating obesity with combinations of bupropion and naltrexone, the two active agents in Contrave, through mid 2024. 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 covers SR compositions of bupropion and naltrexone combined in a single dosage form through March 2025. Upon issuance of the Weber/Cowley methods patent, Orexigen will have four patents that the Company believes will collectively provide broad protection of Contrave in the United States.

-- The Company initiated clinical trials on both of its pipeline product candidates, OREX-003 and OREX-004. OREX-003 is a proprietary sustained release (SR) formulation of zonisamide plus olanzapine. The Phase 2a clinical trial, OZ-101, is designed to examine the effectiveness of OREX-003 in mitigating drug-associated weight gain and other metabolic consequences commonly experienced by patients taking atypical antipsychotic medications, as well as the potential enhancement of antipsychotic activity. OREX-004 is a proprietary SR formulation of naltrexone plus fluoxetine. The Phase 2a clinical trial, NF- 101, is designed to examine the effectiveness of ORE
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SOURCE Orexigen Therapeutics, Inc. Copyright©2008 PR Newswire. All rights reserved

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