, June 2, 2014
/PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), today announced that the United States Food and Drug Administration (FDA) has informed the Company that the FDA intends to reassign the Prescription Drug User Fee Act (PDUFA) action date for the NB32 New Drug Application to June 11, 2014
, one day beyond the original assignment. The FDA noted that due to an inadvertent administrative error, the Agency had miscalculated the originally assigned PDUFA date.
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 adjusted PDUFA date; the timing of potential approval of the NDA for NB32 in the U.S.; and the benefit risk profile for NB32; inclusion of forwardlooking statements should not be regarded as a representation by Orexigen or 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 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 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 Annual 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.