Amgen, Astellas in Japan Alliance

Amgen and Astellas Pharma have entered into a strategic alliance to provide new medicines to help address serious unmet medical needs of Japanese patients. The alliance combines Amgen’s pipeline with Astellas’ experience in Japan.

The first element of the alliance is a long-term collaboration that will focus on the co-development and co-commercialization in Japan of five Amgen pipeline drugs. The five candidates include four biologics and one small molecule and are focused on the treatment of cardiovascular and bone diseases and cancer. The pipeline medicines range from early to late stages of development in Japan, with the first potential commercial launch expected as early as 2016.

The second element of the alliance is the establishment of a Tokyo-based joint venture company through which the companies will work together to enable Amgen to rapidly build on-the-ground capabilities in Japan. The joint venture will operate under the name Amgen Astellas BioPharma KK and will be led by Eiichi Takahashi, who will serve as general manager. Additional management roles will be appointed by Amgen and Astellas. The joint venture will be staffed by employees from Astellas, transferred employees from Amgen, and newly hired employees. It is expected that the JV will start operations on Oct. 1, 2013, but will become wholly owned by Amgen as soon as 2020, with the long-term collaboration continuing.

“Through this alliance, Amgen will work closely with Astellas to leverage its extensive knowledge of the local market,” said Robert A. Bradway, chairman and chief executive officer at Amgen. “With Astellas’ strong capabilities and excellent reputation, this alliance will help accelerate development and commercialization of Amgen medicines for patients in Japan. This alliance reflects our long-term commitment to the Japan market and is an important step in our global expansion efforts.”

“We look forward to entering this alliance with Amgen and believe it will strengthen our pipeline to address unmet medical needs, as well as enable us to obtain growth drivers,” said Yoshihiko Hatanaka, president and chief executive officer of Astellas. “We will work closely with Amgen to build the joint venture, which will provide innovative medicines to patients in Japan.”

Financial terms of the agreement were not disclosed. Drugs covered by the pact are AMG145 for hyperlipidemia, Romosozumab for osteoporosis, Rilotumumab and AMG 337 for gastric cancer, and Blinatumomab for acute lymphoblastic leukemia and non-Hodgkin’s lymphoma.