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The Light Study, A Long-Term Research Study Of Investigational Weight Loss Drug Contrave®, Begins Enrolling Patients Nationwide

SAN DIEGO, June 6, 2012 /PRNewswire/ -- Orexigen ® Therapeutics, Inc. (Nasdaq: OREX) today announced that the Light Study, a long-term research study of Contrave® (naltrexone SR/bupropion SR), a new, investigational drug being evaluated for weight loss, has begun enrolling patients at clinical sites throughout the United States. The Light Study is designed to assess the cardiovascular health outcomes of Contrave.

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Nearly 93 million Americans are affected by obesity, and that number is predicted to increase to 120 million Americans within the next five years.[i] More than one-third of adults in the United States are affected by obesity[ii]. Obesity increases the risk of heart disease, type 2 diabetes, some types of cancer, sleep apnea, and a variety of other conditions. Medical research suggests that losing just five percent of your body weight can significantly improve your health and reduce the risk of complications from type 2 diabetes and heart disease.[iii],[iv]

"We need new alternatives to fight the growing obesity epidemic in the United States," said Steven E. Nissen, M.D., Lead Investigator of the Light Study and Chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at the Cleveland Clinic.[v] "One critical test of any weight loss treatment is its impact on cardiovascular health. The Light Study uses an innovative design that focuses on determining the safety and effectiveness of Contrave in patients who actually lose weight during treatment. This approach simulates how weight loss drugs are used in clinical practice. We think this trial design is a potentially important innovation in the development of new obesity therapies because it is sufficiently rigorous for regulatory authorities and feasible for drug developers, while also incorporating specific elements to help protect the safety of patients."

"Most people cannot achieve long term weight loss by diet and exercise alone," said Steven R. Smith, M.D., Professor and Scientific Director of The Florida Hospital – Sanford-Burnham Translational Research Institute for Metabolism and Diabetes. "The Light Study is an important clinical research study evaluating the cardiovascular health outcomes of Contrave, which is designed to reduce appetite, increase metabolism, and control cravings and overeating behaviors."

In an effort to raise awareness of the obesity epidemic, the potential need for new and diverse treatment options, the benefits of reducing weight to improve certain measures of health and well being, and the Light Study, the Obesity Action Coalition (OAC) has partnered with Orexigen to launch the "Take Five to Live Light" campaign. The campaign encourages those affected by obesity to take five minutes to learn how losing just 5 percent of their weight can benefit cardiovascular health and to take five minutes to get screened for the Light Study. Individuals interested in participating in the Light Study can visit to see if they qualify.

"We are proud to join forces with the OAC to educate the millions of Americans affected by obesity about the health benefits of weight loss," said Michael Narachi, President and Chief Executive Officer of Orexigen.  "The OAC is a strong voice for those affected by obesity and an important partner in the fight against this epidemic.  We encourage those who are interested in joining this cause to consider becoming a member of the OAC."

"The disease of obesity is extremely complex and requires a multidisciplinary team approach to treat it," said Joe Nadglowski, OAC President and CEO. "Many individuals affected by the disease of obesity need access to safe and effective treatment options; however, options are currently limited and new weight-loss management approaches are desperately needed. The OAC is excited to work with Orexigen to support obesity research for safe and effective options through the Light Study. This type of research is imperative in order to offer individuals affected by obesity valid, safe and effective tools to combat their weight and increase their quality of health."

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