Takeda Sells U.S. Rights to Contrave Back to Orexigen, Establishes New Business Units

March 15, 2016
By Alex Keown, BioSpace.com Breaking News Staff

DEERFIELD, Ill. – Takeda Pharmaceuticals will return the U.S. rights to the anti-obesity drug Contrave to its partner Orexigen , the company announced this morning.

Orexigen will pay Takeda $60 million for the U.S. rights to the drug, however Takeda will continue to market Contrave for the next six months, Orexigen said in a statement. Orexigen said it now plans to partner with Valeant Pharmaceuticals to market Contrave in 19 central and eastern European countries, where the drug is marketed as Mysimba.

Takeda said the move will allow the company to focus on its inflammatory bowel disease drugs, gout, diabetes and its products for major depressive disorder. Additionally, Takeda will create two new business units to support its pipeline. A dedicated Specialty Business Unit that will enable Takeda to develop best-in-class capabilities in areas such as patient support and evidence generation. The specialty unit will be helmed by Stephanie Brown, most recently of Biogen . Brown will have the newly created role of vice president of specialty business. To support its new specialty business, Takeda acquired a new U.S. manufacturing site to develop recently-approved Entyvio, a drug to treat adults with moderately to severely active ulcerative colitis and Crohn’s disease.

Takeda’s new General Medicine Business Unit will support marketing operations for the company pipeline. The unit will be helmed by Thomas Gibbs, a senior vice president who most recently worked at Vanda Pharmaceuticals . Gibbs has deep commercial experience across therapeutic areas that include CNS, diabetes and others, Takeda said in a statement.

"Takeda is focusing resources behind opportunities where we can lead; we are making very deliberate strategic choices on where we will invest, and where we won't," Ramona Sequeira, president of Takeda Pharmaceuticals U.S.A., Inc. said in a statement. "We want to ensure we are focused on areas where we can provide the most value for patients over the long-term."

One reason Takeda may have been happy to shed Contrave was lackluster sales. The drug has only been generating about $13 million to $15 million each quarter, Seeking Alpha said. Contrave sales have lagged behind other anti-obesity drugs such as Vivus Inc. ’s Qsymia.

Takeda’s relationship with Orexigen had some bumps after Michael Narachi, chief executive officer of Orexigen, shared the results of an interim analysis of a Contrave trial. The early information showed incredibly positive results, however, that revelation compromised the trial, Harjes said. The FDA demanded a trial redo and Orexigen’s partner Takeda Pharmaceuticals handed the full costs of the redo, about $200 million, over to Orexigen.

Contrave was approved for use in extremely overweight individuals in 2014 by the U.S. Food and Drug Administration. According to the FDA, Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, in an extended-release formulation. Naltrexone is approved to treat alcohol and opioid dependence. Bupropion is approved to treat depression and seasonal affective disorder (SAD) and as an aid to smoking cessation treatment. Following approval, the FDA required a new cardiovascular outcomes trial as a post-marketing requirement for the “evaluation of the effects of long-term treatment with Contrave on the incidence of major adverse cardiovascular events in overweight and obese subjects with CV disease or multiple CV risk factors.”

Takeda stock, which trades on the Tokyo Stock Exchange, is down this morning, trading at 5,451 Yen, or about $48.32 per share.