Amgen, an independent biotechnology company, and Astellas Pharma, a Tokyo-based global pharmaceutical company, have entered into an alliance to provide new medicines to help address serious unmet medical needs of Japanese patients.

The alliance combines Amgen's pipeline candidates with Astellas' knowledge of Japanese patient and physician needs, long-term commercial and regulatory experience, and strong presence as a company in Japan.

The first element of the alliance is a long-term collaboration between the two companies that will focus on the co-development and co-commercialization in Japan of five Amgen pipeline medicines. The five medicines, which include four biologics and one small molecule, 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 build on-the-ground capabilities in Japan. The joint venture will operate under the name Amgen Astellas BioPharma 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 seconded employees from Astellas, transferred employees from Amgen and newly hired employees.

The joint venture is expected to begin operations on Oct. 1, 2013, and will become a wholly owned Amgen affiliate as early as 2020 with the long-term collaboration continuing.

"With Astellas' strong capabilities and excellent reputation, this alliance will help accelerate development and commercialization of Amgen medicines for patients in Japan,” said Robert A. Bradway, chairman and CEO at Amgen. “This alliance reflects our long-term commitment to the Japan market and is an important step in our global expansion efforts."  

Goldman Sachs is acting as financial advisor to Amgen in connection with this transaction. Morrison & Foerster served as external legal counsel to Astellas.