Orexigen Announces June 10, 2014 PDUFA Action Date for Contrave
, Jan. 7, 2014
/PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), today announced that the United States Food and Drug Administration (FDA) considers the recent resubmission of the Contrave® (naltrexone sustained release (SR)/bupropion SR) New Drug Application to be a complete response to the FDA's prior January 31, 2011
action letter. For the resubmission, the FDA has assigned a Prescription Drug User Fee Act goal date of June 10, 2014
. If approved, the Company expects commercial launch of Contrave by North American partner Takeda Pharmaceuticals in the second half of 2014.
"We will continue to work closely with the FDA during the review of the Contrave NDA resubmission, and, if approved, we and Takeda look forward to making Contrave available to patients soon thereafter," said Michael Narachi, CEO of Orexigen.
Orexigen resubmitted the Contrave NDA in December 2013 following the earlier announcement of the successful interim analysis of the Light Study, the Contrave cardiovascular outcomes trial.
About the Light Study
The Contrave Light Study is a double-blind, placebo-controlled cardiovascular outcomes trial that randomized approximately 8,900 patients. The primary objective of the Light Study, which Orexigen is conducting under a Special Protocol Assessment with the FDA at approximately 260 clinical sites in the United States, is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave. In November 2013 Orexigen announced successful results of the interim analysis of the Light Study, stating that it met the prespecified criteria to exclude a hazard ratio of 2.0, using the upper bound of the 95% confidence interval, for excess risk of major adverse cardiovascular events (MACE) in patients receiving Contrave as compared to placebo.
Contrave (naltrexone sustained release (SR)/bupropion SR) is an investigational medication being evaluated for weight loss and maintenance of weight loss. Prior to initiation of the Light Study, Contrave was studied in clinical trials enrolling more than 4,500 people. In these clinical trials, 53 percent of study participants taking Contrave and 21 percent of those taking placebo lost five percent or more of their body weight over the 12 month trial duration. Many patients saw improvements in cholesterol levels and blood sugar control. Those who combined Contrave with intensive diet and exercise experienced the most reduction in body weight. There is no guarantee that Contrave will help patients lose weight.
In the Contrave Phase 3 clinical development program, the most frequent adverse events in patients on Contrave were nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea. These were mostly mild to moderate in severity.
Orexigen has licensed North American Contrave rights to Takeda Pharmaceuticals. Orexigen owns Contrave rights in Europe and throughout the rest of the world outside of North America and will seek a partner to commercialize Contrave in those territories. In October 2013, Orexigen submitted a Marketing Authorization Application (MAA) for Contrave to the European Medicines Agency (EMA).
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product candidate is Contrave®. Based on successful results of the Light Study, an ongoing cardiovascular outcomes trial, Orexigen's strategy for Contrave 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 Contrave 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 forwardlooking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "should," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forwardlooking statements. These statements are based on the Company's current beliefs and expectations. These forwardlooking statements include statements regarding: the PDUFA action date and potential approval of the NDA for Contrave in the U.S.; the benefit risk profile for Contrave; and Orexigen's plan to seek a commercialization partner in territories outside of North America. The 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 SPA is not binding on the FDA if public health concerns unrecognized at the time the SPA agreement was entered into become evident, other new scientific concerns regarding product safety or efficacy arise, or if Orexigen fails to comply with the agreed upon trial protocol; the potential for the FDA to not approve Contrave even after meeting the prespecified threshold and resubmitting the NDA; the possibility that public disclosure of the results of the interim analysis 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 potential for early termination of Orexigen's North American collaboration agreement with Takeda; even if the NDA is approved by the FDA, the final results of the Light Study may not support continued approval of Contrave; the therapeutic and commercial value of Contrave; 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 Current Report on Form 8-K filed with the Securities and Exchange Commission December 2, 2013 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.