SAN DIEGO, CA, USA I November 25, 2013 I Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced successful results of the interim analysis of the Light Study. Based on these results, the Company will resubmit the Contrave® New Drug Application (NDA) to the United States Food and Drug Administration (FDA) in the next few weeks with potential approval by June 2014.
“The interim analysis of the Light Study clearly achieved the goal set by the FDA,” said Michael Narachi, CEO of Orexigen. “The resubmission will contain an unprecedented amount of cardiovascular outcomes data for an obesity therapeutic, and we are confident these data will support a favorable benefit:risk assessment for Contrave.”
The FDA previously agreed that if the interim analysis meets the specified criteria to exclude cardiovascular risk, Contrave could be approved. The pre-specified criteria for the interim analysis is 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. In addition to meeting the pre-specified criteria for excluding cardiovascular risk, no new safety signals were observed.
“Takeda is excited about this major milestone for Contrave,” said Doug Cole, President of Takeda Pharmaceuticals U.S.A., Inc., Orexigen’s partner for Contrave in North America. “Takeda is pleased to partner with Orexigen to develop a therapeutic option that has the potential to help patients achieve meaningful and sustained weight loss over time.”
Conference Call This Morning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time)
The Orexigen management team will host a teleconference and webcast to discuss the interim analysis results. The live call may be accessed by phone by calling (888) 895-5479 (domestic) or (847) 619-6250 (international), participant code 36202424. The webcast can be accessed live on the Investor Relations section of the Orexigen web site at www.orexigen.com and will be archived for 14 days following the call.
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.
By agreement with the FDA, the independent Data Monitoring Committee’s summary report of the Light Study interim analysis will form the basis of the resubmission of the NDA, and the complete clinical study report (CSR) for the interim analysis, which would ordinarily form the basis for the NDA resubmission filing, will be supplied to the FDA during its review within 60 days of the NDA resubmission.
Following potential approval in June 2014, the Light Study will continue, blinded, until the trial is completed.
About Contrave
Contrave (naltrexone sustained release (SR)/bupropion SR) is an investigational medication being evaluated for weight loss. Prior to initiation of the Light Study, Contrave was studied in clinical trials enrolling more than 4,500 people. Contrave has been shown to help people lose weight and keep it off for up to one year. In previous 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 noticeable improvements in cholesterol levels, and blood sugar control, as well as smaller waistlines. Those who combined Contrave with diet and exercise experienced the most reduction in body weight. There is no guarantee that Contrave will make patients lose weight.
Contrave was generally well tolerated in earlier clinical trials. In the Contrave Phase 3 clinical development program, the most frequent adverse events on Contrave were nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea. These were mostly mild to moderate in severity and did not last long.
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, which has completed Phase 3 clinical trials and for which a New Drug Application had been submitted and reviewed by the FDA. The Company has also reached agreement with the FDA on a Special Protocol Assessment (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.
SOURCE: Orexigen Therapeutics
