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Orexigen Therapeutics, Inc. (OREX) Expands NB32 Intellectual Property Portfolio With New U.S. Patent



9/3/2014 11:23:32 AM

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Patent Protection for NB32 for Treating Insulin Resistance

SAN DIEGO, Sept. 2, 2014 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced that the U.S. 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.

U.S. 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.

Intellectual Property Protecting NB32

NB32 is currently protected by U.S. patent number 7,375,111 and U.S. 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.

About Orexigen Therapeutics

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.

ForwardLooking 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," "should," "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 potential for U.S. Patent No. 8,815,889 to be listed in the Orange Book; the potential for U.S. Patent No. 8,815,8891 to enhance the value of NB32; the expected expiration dates of the intellectual property covering NB32; and the potential for the FDA or CHMP to approve NB32 in 2014. Inclusion of forwardlooking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the potential for a generic competitor to successfully argue that U.S. Patent No. 8,815,889 should not be listed in the Orange Book or invalidate one or more of the patents covering NB32; the potential for the FDA and/or the CHMP to not approve NB32 in 2014; the worldwide therapeutic and commercial value of NB32; and other risks described in Orexigen's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forwardlooking 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. Further information regarding these and other risks is included under the heading "Risk Factors" in Orexigen's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission August 8, 2014 and its other reports, which are available from the SEC's website (www.sec.gov) and on Orexigen's website (www.orexigen.com) under the heading "Investor Relations." All forwardlooking 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 Contact:

Media Contact:

McDavid Stilwell

Denise Powell

VP, Corporate Communications and Business Development

BrewLife

(858) 875-8629

(510) 703-9491

SOURCE Orexigen Therapeutics, Inc.

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