SAN DIEGO, July 29 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. today announced that the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for a patent application that would provide broad coverage for a pharmaceutical composition of zonisamide in combination with a series of marketed atypical antipsychotics. Orexigen is currently evaluating a combination product, OREX-003, for the treatment of schizophrenia that it hopes would minimize the potential for weight gain or other adverse metabolic consequences often observed in patients receiving atypical antipsychotic medications.
OREX-003 combines a proprietary sustained release formulation of zonisamide plus olanzapine (marketed as Zyprexa(R)). Preclinical studies conducted by Orexigen demonstrated that the addition of zonisamide prevented weight gain and elevated blood glucose associated with olanzapine alone. Zonisamide appears to reverse the olanzapine effects on appetite pathways in the brain as well as directly on peripheral fat cells, resulting in mitigation of weight gain and elevated blood sugar associated with olanzapine treatment. OZ-101, the Company's Phase II proof of concept trial for OREX-003, is scheduled to begin in the third quarter this year.
"This patent represents another successful milestone for Orexigen. If OREX-003 retains the proven efficacy profile of olanzapine while mitigating possible safety concerns, then it will address a significant public health challenge," said Orexigen President and CEO Gary Tollefson, M.D., Ph.D. "Research has indicated that the weight gain associated with atypical antipsychotics may impact compliance with treatment and, in turn, place patients at an increased risk of relapse. In contrast, staying on treatment and gaining significant body weight may place them at risk for a number of obesity-related metabolic disorders. We believe that OREX-003 has the potential to eliminate this conundrum."
Despite the commercial success of Zyprexa(R), IMS data shows that new prescriptions have declined by approximately 50% from 2003 to 2007, likely as a result of side effects, particularly excessive weight gain. According to the package insert for Zyprexa(R), 56% of patients gained 7% or more of baseline body weight in long-term clinical trials.
If issued, this patent will also cover zonisamide in combination with other atypical antipsychotics, including clozapine, risperidone, quetiapine, aripiprazole and ziprasidone. Zonisamide is also a component of the Company's obesity treatment candidate Empatic(TM), which is in the later stages of Phase II clinical development.
About Orexigen Therapeutics
Orexigen(R) Therapeutics, Inc. is a biopharmaceutical company focused on the development of pharmaceutical product candidates for the treatment of central nervous system disorders, including obesity. The Company's lead combination product candidates targeted for obesity are Contrave(R), which is in Phase III clinical trials, and Empatic(TM), which is in the later stages of Phase II 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 issuance of a patent covering a pharmaceutical composition of zonisamide in combination with a series of marketed atypical antipsychotics, the efficacy and safety of OREX- 003, and the timing of the initiation of the Company's OZ-101 clinical trial. 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 Company's business, including, without limitation: the progress and timing of the Company's clinical trials or the development of OREX-003; the potential for adverse safety findings relating to its product candidates to delay or prevent regulatory filings; and Orexigen or 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 the Company's filings with the Securities and Exchange Commission (SEC). 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.
CONTACT: Graham Cooper of Orexigen, +1-858-875-8600, or Media, Liz Frank,
+1-212-301-7216
Web site: http://www.orexigen.com/
