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Orexigen(R) Therapeutics Initiates First Clinical Trial of OREX-003 for the Mitigation of Antipsychotic-Associated Weight Gain
Date:10/2/2008

- Two Milestones Reached in Zonisamide Patent Portfolio -

SAN DIEGO, Oct. 2 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders, today announced the initiation of its first clinical trial with OREX-003, a proprietary sustained release 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/or other metabolic consequences commonly experienced by patients taking atypical antipsychotic medications, as well as the potential enhancement of antipsychotic activity.

In additional Company news, the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 7,425,571 providing broad coverage of the use of zonisamide either alone or in combination with other drugs for the treatment of obesity through 2023. The USPTO has also issued U.S. Patent No. 7,429,580 which broadly covers zonisamide in combination with various marketed atypical antipsychotics including olanzapine, clozapine, risperidone, quetiapine, aripiprazole and ziprasidone through 2025. We believe that these patents complement each other and provide a strong patent portfolio for OREX-003. Orexigen has licensed both patents on an exclusive basis from Duke University.

"The initiation of the OZ-101 clinical trial and progress in securing comprehensive intellectual property coverage for zonisamide are important milestones for Orexigen as we grow our product candidate pipeline beyond our initial obesity programs by extending into other central nervous system disorders," said Gary Tollefson, M.D.,
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SOURCE Orexigen Therapeutics, Inc.
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