SAN DIEGO, Aug. 27, 2013 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that the Light Study independent Data Monitoring Committee has recently confirmed that sufficient major adverse cardiovascular events (MACE) are expected to occur within the next two months, enabling the interim analysis to be conducted by early December and the potential resubmission of the Contrave® New Drug Application (NDA) by year end. The DMC also recommended that the Light Study continue as planned with no changes to the protocol.
"I'm proud of the progress made by our Light Study team," said Michael Narachi, Chief Executive Officer of Orexigen. "We remain focused on trial execution and launch preparation and look forward to the interim analysis and upcoming regulatory submissions."
Orexigen also today reiterated its plan to submit a Marketing Authorization Application (MAA) for Contrave® to the European Medicines Agency (EMA) in advance of the Light Study interim analysis and to have cardiovascular outcomes data from the Light Study available for the Committee for Medicinal Products for Human Use (CHMP) Day 120 List of Questions.
About Contrave (32 mg naltrexone sustained‐release (SR)/360 mg bupropion SR) for the treatment of obesity: In 2012, Orexigen screened more than 13,000 patients, enrolled more than 10,400 and ultimately completed recruitment of the Light Study with approximately 8,900 randomized patients. The primary objective of the double‐blind, randomized, placebo‐controlled Light Study, which Orexigen is conducting under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA), is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave. An interim analysis and NDA resubmission is planned once the DMC has determined that sufficient information has been gathered for the analysis that would include at least 87 adjudicated MACE.
Orexigen has licensed North American commercial rights to Takeda Pharmaceuticals. Orexigen owns Contrave rights throughout the rest of the world and intends to license commercial rights outside North America.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product candidate is Contrave, which has completed Phase 3 clinical trials and for which a NDA has been submitted and reviewed by the FDA. The Company has also reached agreement with the FDA on a SPA for the Light Study, the Contrave cardiovascular outcomes trial. 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 potential for, and timing of, the interim analysis and submission of a Contrave NDA; the potential for, and timing of, the accrual and adjudication of MACE; the expected retention rate for patients in the Light Study; the probability of success of the Light Study; the possibility of resubmitting the Contrave NDA with the independent DMC report on the interim analysis and without the clinical study report for the interim analysis; the potential to accelerate the timing of the review of the Contrave NDA; the safety and effectiveness of Contrave; the potential for past Contrave clinical trials to predict the outcome of future Contrave clinical trials; the SPA and the protocol for the Contrave® cardiovascular outcomes trial, or Light Study; the potential for and timing of a submission of an MAA in the European Union; the potential for approval of the Contrave MAA by the EMA; and the potential to license commercial rights to Contrave outside North America. The inclusion of forward‐looking 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 possibility that the FDA determines not to initiate review of the Contrave NDA until it has received the complete study report for the interim analysis; 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; Orexigen's ability to conduct the Light Study and the progress and timing thereof, including risks associated with enrolling and retaining the appropriate patients in the Light Study; Orexigen's ability to demonstrate in the Light Study that the risk of MACE in overweight and obese patients treated with Contrave does not adversely affect Contrave's benefit‐risk profile; the potential that earlier clinical trials may not be predictive of future results in the Light Study; the potential for the FDA to not approve Contrave even after the resubmission with the MACE data; the potential for the Light Study to cost more than what is projected; the potential for early termination of Orexigen's North American collaboration agreement with Takeda Pharmaceutical Company Limited; the costs and time required to complete additional clinical, non‐clinical or other requirements prior to any resubmission of the Contrave NDA; the therapeutic and commercial value of Contrave; Orexigen's ability to maintain sufficient capital to fund our operations through potential approval of Contrave in 2014; Orexigen's ability to enter into a collaborative partnership for Contrave outside North America on acceptable terms, if at all; and other risks described in Orexigen's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward‐looking 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‐K filed with the Securities and Exchange Commission March 14, 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 forward‐looking 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.
Media Contact: McDavid Stilwell
Denise PowellVP, Corporate Communications and Business Development
|SOURCE Orexigen Therapeutics, Inc.|
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