SAN DIEGO - Orexigen Therapeutics Inc. today announced in a press release that the US Patent and Trademark Office (PTO) has issued a patent related to NB32, the Company's investigational medication being evaluated for weight loss. NB32 is a fixed-dose combination of naltrexone sustained release (SR) and bupropion SR.
US Patent No. 8,815,889 claims methods for treating insulin resistance using a composition including naltrexone and bupropion. The patent expires in 2024. If NB32 is approved for use in the United States, Orexigen expects the patent to be listed in the Orange Book maintained by the United States Food and Drug Administration. A counterpart application to this patent has issued in Europe and other international jurisdictions.
"As we ready NB32 for commercialization and plan for lifecycle development, the issuance of this patent adds to our growing intellectual property portfolio and, we believe, enhances the value of the asset," said Michael Narachi, CEO of Orexigen.
NB32 is currently protected by US patent number 7,375,111 and US patent number 7,462,626, which Orexigen refers to collectively as the Weber/Cowley patents and which are expected to expire in 2025/2024. The Weber/Cowley patents cover the current composition of NB32 and methods of administering it to treat obesity. Orexigen and/or licensors have filed a number of international counterparts to the Weber/Cowley patents in foreign countries. A European counterpart application to the Weber/Cowley patent has issued in the European Patent Office, or EPO, and provides protection for NB32 in the various EPO countries in which the patent has been registered. Orexigen has also filed patent applications, directed to various treatment and formulation aspects of NB32, in the United States and certain foreign countries under the Patent Cooperation Treaty, or PCT.
Use of a proprietary tri-layer NB32 tablet for weight loss is protected in the United States by U.S. patent numbers 8,088,786 and 8,318,788, which are expected to expire in February 2029 and November 2027, respectively. In addition, the dose escalation schedule of Contrave is protected by U.S. patent 8,722,085, which is expected to expire in November 2027. Orexigen has filed other patent applications in the United States and other parts of the world with the potential, if the patents issue, to extend intellectual property protection as late as 2034.
Orexigen Therapeutics Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product candidate is NB32. Based on successful results of the Light Study, an ongoing cardiovascular outcomes trial, Orexigen's strategy for NB32 is to pursue approvals worldwide and pharmaceutical partnerships for global commercialization. The Company has submitted applications for marketing authorization in the United States and Europe, with potential approvals in 2014. If approved, North American partner Takeda Pharmaceuticals will commercialize NB32 in the United States. The Company's other product candidate, Empatic™, has completed Phase 2 clinical trials. Further information about the Company can be found at www.orexigen.com.