All Participants in the Contrave® Light Study Will Also Enroll in WeightMate
(San Diego and Atlanta – June 6, 2012) – Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, and Sharecare® an interactive health and wellness social platform providing people with access to expert-developed answers, information and programs to live their healthiest life, announce their partnership for WeightMate™, a comprehensive weight management program developed for participants in the Light Study. Delivered through an internet-based platform by accredited health and fitness professionals, WeightMate provides a convenient, progressive nutrition and exercise program with goal setting and tracking tools. The Light Study (www.lightstudy.com) is a long-term research study designed to assess the cardiovascular health outcomes associated with an investigational drug, Contrave®(naltrexone SR/bupropion SR), which is being evaluated as a new treatment for obesity.
“WeightMate provides participants in the Light Study with a robust coaching and information platform that is designed to help them make changes in their diet and lifestyle to help them lose weight,” said Dr. Mike Clark, Chief Science Officer of Sharecare. “We are excited to work with Orexigen to launch WeightMate, which combines Sharecare’s digital expertise in providing expert health knowledge and interactive fitness programs with Orexigen’s focus on developing safe and effective new treatments for obesity, which is one of the biggest health care problems facing the United States.”
“At Orexigen, we believe weight loss medicines should be used with an effective behavior modification program that is designed to help people make the necessary changes in their lifestyle and diet and provides them with the opportunity to optimize their weight loss,” said Michael Narachi, CEO of Orexigen. “We partnered with Sharecare to build WeightMate for all participants in the Light Study to provide comprehensive and personalized weight management tools to assist study participants in achieving their health goals. We are very excited to be partnering with Sharecare on WeightMate.”
About the Light Study
The Light Study (www.lightstudy.com) is a randomized, double-blind, placebo-controlled cardiovascular outcomes trial evaluating the occurrence of major adverse cardiovascular events (MACE) in patients participating in the study. An interim analysis and NDA resubmission is planned once approximately 87 MACE events have occurred, which is anticipated to be less than two years from the start of the trial. If marketing approval is received for Contrave, the trial will continue toward the final analysis in the post-approval setting. It is expected to enroll up to 10,000 study participants at approximately 300 research sites nationwide.
Contrave (naltrexone SR/bupropion SR) is an investigational medication being evaluated for weight loss. Contrave has been studied to date in clinical trials enrolling more than 4,500 people and was developed by Orexigen to reduce appetite, help control cravings, increase metabolism and improve control over eating behaviors. 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. Those who took Contrave for six months, combined with a structured weight management program, lost an average of 25 pounds, compared with 17 pounds for those using the weight management program and receiving placebo. 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 clinical trials. In the Contrave 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 short in duration.
WeightMateTM is a comprehensive weight management program developed in partnership by Orexigen and Sharecare. Delivered through an internet-based platform by accredited health and fitness professionals, WeightMate provides a convenient, progressive nutrition and exercise program with goal setting and tracking tools designed to help users achieve their health goals.
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 III clinical trials and for which a New Drug Application has been submitted and reviewed by the FDA. The Company has also reached agreement with the FDA on a Special Protocol Assessment for the Light Study, the Contrave cardiovascular outcomes trial. The Company’s other product candidate, EmpaticTM, has completed Phase II clinical trials. Further information about the Company can be found at www.orexigen.com.
Launched in 2010 and based in Atlanta, GA, Sharecare is an interactive, social Q & A platform that allows people to ask, learn and act upon questions of health and wellness. Created by Jeff Arnold and Dr. Mehmet Oz, in partnership with Harpo Studios, Remark Media (NASDAQ: MARK), Sony Pictures Television, and Discovery Communications, the company’s innovative approach provides the consumer access to a wide array of health and wellness experts ranging from hospitals to doctors, specialists to non-profits, to healthcare companies and active health consumers, creating a thriving community where healthcare knowledge is built, shared and put into practice.
Orexigen Forward-Looking Statements
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,” “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 ability of the WeightMate program to help patients make changes in their diet and lifestyle and to help optimize weight loss, the safety and effectiveness of Contrave; the ability and speed of patient enrollment in the Light Study, the potential for, and timing of, the accrual of MACE events, the resubmission of the Contrave NDA, and the potential for, and timing of, approval for Contrave.. 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 from those set forth 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; Orexigen’s ability toconduct the Light Study and the progress and timing thereof; Orexigen’s ability to demonstrate in the Light Study that the risk of major adverse cardiovascular events in overweight and obese subjects treated with Contrave does not adversely affect the product candidate’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 event data; the potential for early termination of the collaboration agreement between Orexigen and Takeda; the costs and time required to complete additional clinical, non-clinical or other requirements prior to any resubmission of an NDA; the therapeutic and commercial value of Contrave; Orexigen’s ability to maintain sufficient capital; and other risks described in the Company’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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission May 10, 2012 and which is 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.