Orexigen Therapeutics Announces Notice of Allowance for U.S. Patent Strengthening Exclusivity for Empatic for Obesity

Feb 21, 2008 - Orexigen(TM) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, today announced that a Notice of Allowance has been issued by the United States Patent and Trademark Office (USPTO) for a patent application providing broad coverage of the use of zonisamide either alone or in combination with other drugs in the treatment of obesity. Zonisamide is an active constituent of Empatic(TM), a novel formulation of zonisamide sustained release (SR) paired with bupropion SR, for the treatment of obesity. The combination of these two drugs is designed to provide more clinically meaningful weight loss for patients by both initiating weight loss and sustaining it over a longer period of time. The Phase IIb clinical trial for Empatic was completed last year, and the Company plans to initiate another Phase IIb clinical trial for Empatic this year.
This patent, when issued, would complement an issued U.S. patent (7,109,198) that Orexigen has exclusively licensed from Duke University protecting the use of zonisamide to promote weight-loss in combination with bupropion. Both patents would expire in 2023.
"This notice from the USPTO is an important milestone toward issuance of the patent and would give us an additional layer of protection for our use of zonisamide in treating obesity," said Orexigen President and CEO, Gary Tollefson, M.D., Ph.D. "We believe this strengthens our intellectual property rights with Empatic, and may block attempts to copy our approach to treating obesity with any zonisamide-based compounds."
Empatic is one of two Orexigen compounds in late stage clinical development for obesity. In January, the Company presented 48 week Empatic Phase IIb clinical trial results which demonstrated weight loss ranging from approximately 12% to 15% in patients who completed the trial under double blind treatment. Results depended on the dose of the constituent drugs used, with the highest dose achieving the greatest weight loss. Results of this trial also indicated that Empatic was safe and generally well tolerated.