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 did not last long.
WeightMate™ is a comprehensive weight management program developed for the Light Study through a partnership between Orexigen and Sharecare, an interactive social, Q&A platform created by Jeff Arnold and Dr. Mehmet Oz in partnership with Harpo Studios, Remark Media, Sony Pictures Television and Discovery Communications. 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 to help users achieve their health goals.
About Orexigen TherapeuticsOrexigen 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 (SPA) for the Light Study, the Contrave cardiovascular outcomes trial. The Company's other product candidate, Empatic™, has completed Phase II clinical trials. Further information about the Company can be found at www.orexigen.com. About the Obesity Action Coalition (OAC) The OAC is the only non-profit organization whose sole focus is representing individuals affected by obesity. Founded in 2005, the OAC remains at the forefront of the fight against obesity. From advocating on capitol hill for access to obesity treatments to publishing hundreds of educational resources for individuals affected, the OAC truly represents the voice of all those affected by obesity. For more information on the OAC, please visit www.obesityaction.org. 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 Light Study; 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 and the potential 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 Special Protocol Assessment (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; Orexigen's ability to demonstrate in the Light Study that the risk of MACE 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. [i] Understanding obesity: an educational resource provided by the Obesity Action Coalition. Obesity Action Coalition. Available at http://www.obesityaction.org/wp-content/uploads/Understanding_Obesity.pdf. Accessed on April 4, 2012. [ii] Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity in the United States, 2009–2010. NCHS data brief, no 82. Hyattsville, MD: National Center for Health Statistics. 2012. [iii] Wing RR, Lang W, Wadden TA, et al. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 2011 Jul;34(7):1481-6. [iv] Williamson DF, Thompson TJ, Thun M, et al. Intentional weight loss and mortality among overweight individuals with diabetes. Diabetes Care. 2000 Oct;23(10):1499-504. [v] Dr. Nissen has no financial relationship with Orexigen.
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