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SAN DIEGO, July 30, 2014 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced it has received the Day 180 List of Outstanding Issues (LOI) from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the NB32 Marketing Authorization Application (MAA). NB32 (naltrexone sustained release (SR) / bupropion SR) is an investigational drug candidate being evaluated for weight loss.
The key questions of the earlier Day 120 time point were adequately addressed by the Company based in part on the interim analysis of the Light Study cardiovascular outcomes trial. However, the Day 180 LOI raised new issues. Specifically, the CHMP requested further justification of the balance of benefits and risks of NB32 treatment as well as additional information regarding post-approval risk minimization measures and pharmacovigilance activities. Details were also requested of the Company's third-party suppliers of bupropion related to their starting materials.
The Company believes the CHMP's requests are addressable. However, in regards to the third-party suppliers, in order to have the time to coordinate responses from these suppliers, Orexigen has requested an extension of one month and plans to submit its response to the Day 180 LOI in September.
"We believe NB32 has a benefit risk profile that supports approval, and we are confident in our ability to justify its profile to the CHMP," said Michael Narachi, CEO of Orexigen.
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.
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 timing of the Company's response to the Day 180 LOI; the benefit risk profile for NB32; the ability of the Company to justify the approvability of NB32 to the CHMP; and the potential for the FDA or CHMP to approve NB32. 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 the CHMP to not approve NB32; the potential for the FDA to not approve NB32 even after meeting the prespecified threshold and resubmitting the NDA; the possibility that public disclosure of the results of the interim analysis of the Light Study would later be deemed to jeopardize the integrity of the Light Study potentially resulting in the requirement to conduct additional, costly studies; additional analysis of the interim results or new data from the continuing Light Study, including safety-related data, may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim analysis was successful; the potential that the interim analysis may not be predictive of future results in the Light Study; 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 May 9, 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.
VP, Corporate Communications and Business Development
SOURCE Orexigen Therapeutics, Inc.