Orexigen(R) Therapeutics Initiates First Clinical Trial Of OREX-003 For The Mitigation Of Antipsychotic Associated Weight Gain

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 03 Oct 2008 - 0:00 PDT

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Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders, 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., Ph.D., Orexigen President and CEO. "Based on our preclinical data, we believe that OREX-003 has the potential to have an improved metabolic profile and be a more effective long-term option in the management of schizophrenia and a number of related conditions."

About OZ-101

The OZ-101 clinical trial is a double-blind, placebo-controlled clinical trial evaluating the combination of olanzapine plus zonisamide SR versus olanzapine plus placebo in 75 patients with schizophrenia over 16 weeks at nine centers in the U.S. Preclinical studies conducted by Orexigen have demonstrated that zonisamide mitigated both weight gain and elevated blood glucose associated with olanzapine through novel mechanisms. The clinical trial is currently enrolling. More information can be found at http://www.clinicaltrials.gov.

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders. The Company's lead combination product candidates targeted for obesity are Contrave(R), which is in Phase 3 clinical trials, and Empatic(TM), which is in late-stage of Phase 2 clinical development. 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. Beyond obesity, Orexigen is developing drug combinations for use in schizophrenia and obsessive-compulsive disorder. Further information about the company can be found at http://www.Orexigen.com.

Forward Looking Statements

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 the Company's current beliefs and expectations. These forward-looking statements include statements regarding the enrollment, timing, execution and completion of clinical trials of its product candidates, the potential to obtain regulatory approval for, and effectively treat antipsychotic-associated weight gain with OREX-003, and the scope and duration of protection of issued patents relating to the Company'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 the Orexigen business, including, without limitation: the progress and timing of the Company's clinical trials; the potential that earlier clinical trials may not be predictive of future results; the ability for the Company's product candidates to receive regulatory approval on a timely basis or at all; the potential for adverse safety findings relating to the Company's product candidates to delay or prevent regulatory approval or commercialization, or result in product liability claims; the ability of Orexigen and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates; and other risks described in the Company's filings with the Securities and Exchange Commission. 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.

Orexigen Therapeutics, Inc.
http://www.Orexigen.com