Takeda and Orexigen Announce FDA Approval of Contrave Extended-Release Tablets for Chronic Weight Management

Takeda Pharmaceutical Company Ltd, its wholly-owned subsidiary Takeda Pharmaceuticals USA, Inc. and Orexigen Therapeutics, Inc. have jointly announced that FDA has approved Contrave (naltrexone HCI and bupropion HCI) extended-release tablets as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition.

“Some individuals seeking to manage their weight may require a treatment plan that includes more than
lifestyle modification with diet and exercise,” said Dr Ken Fujioka, Director, Center for Weight Management,
Division of Diabetes and Endocrinology at Scripps Clinic. “Clinical trial data for Contrave demonstrates that
this new treatment, when used as an adjunct to a reduced-calorie diet and increased physical activity, is a
therapeutic option for some adults who are either overweight with a comorbidity, or obese. In my clinic I
often treat patients who fit these criteria, and now, with the approval of Contrave, I am excited to have a new
treatment option to consider for my patients.”

“The FDA approval of Contrave is a significant milestone in Takeda's and Orexigen’s commitment to
leading innovation in medicine for patients and physicians dealing with chronic conditions and diseases,
such as obesity,” said Douglas Cole, President, Takeda Pharmaceuticals USA, Inc. “It’s important that
physicians and appropriate patients have options when discussing weight management, especially when
you look at the prevalence of obesity in today’s society. We’re excited about the addition of Contrave to
our Cardiovascular and Metabolic Disease Portfolio.”

Contrave is an important addition to Takeda’s portfolio of cardiometabolic products. Takeda is committed
to providing patients with obesity with treatment options that help address their needs, and the company is
planning to commercially launch Contrave in the fall of 2014.