Orexigen Therapeutics, a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, today announced that a Notice of Allowance has been electronically posted by the United States Patent and Trademark Office (USPTO) for a patent application covering sustained release (SR) compositions of bupropion and naltrexone combined in a single dosage form. These two drugs are the active constituents in Contrave(TM), Orexigen's lead product candidate for the treatment of obesity, now in Phase III clinical trials. Referred to by the Company as the Weber/Cowley composition patent application, this patent would provide protection for Contrave into the year 2024. This development is an important milestone toward issuance of the patent by the USPTO. Issuance of this patent by the USPTO would extend the Company's exclusive rights on this combination in the United States for an additional 11 years beyond its current patent protection.
Contrave is a proprietary fixed dose combination of bupropion SR and the Company's novel formulation of naltrexone SR in a single tablet. Orexigen chose these two constituent drugs based on preclinical data that suggested that they could both initiate and sustain weight loss. The Contrave Phase IIb clinical trial at 48 weeks demonstrated weight loss from baseline body weight that ranged from 8.0% to 10.7% across the three Contrave dosage groups among patients who completed the trial. The Phase III clinical trials of Contrave are expected to be completed by mid-2009 with the filing of a New Drug Application (NDA) with the FDA projected for late 2009.
"This patent, upon issuance, would further strengthen the intellectual property position for this novel, proprietary drug combination," said Orexigen President and CEO, Gary Tollefson, M.D., Ph.D. "As a composition-of-matter patent it would cover all uses and doses of Contrave into 2024."
Contrave is a proprietary fixed dose combination of bupropion SR and the Company's novel formulation of naltrexone SR in a single tablet. Orexigen chose these two constituent drugs based on preclinical data that suggested that they could both initiate and sustain weight loss. The Contrave Phase IIb clinical trial at 48 weeks demonstrated weight loss from baseline body weight that ranged from 8.0% to 10.7% across the three Contrave dosage groups among patients who completed the trial. The Phase III clinical trials of Contrave are expected to be completed by mid-2009 with the filing of a New Drug Application (NDA) with the FDA projected for late 2009.
"This patent, upon issuance, would further strengthen the intellectual property position for this novel, proprietary drug combination," said Orexigen President and CEO, Gary Tollefson, M.D., Ph.D. "As a composition-of-matter patent it would cover all uses and doses of Contrave into 2024."
