THOUSAND OAKS, Calif., and TOKYO (May 29, 2013) – Amgen (NASDAQ:AMGN), the world’s largest independent biotechnology company, and Astellas Pharma Inc. (Tokyo Stock Exchange: 4503, “Astellas”), a leading Tokyo-based global pharmaceutical company, today announced the companies have entered into a strategic alliance to provide new medicines to help address serious unmet medical needs of Japanese patients.
The alliance leverages the complementary capabilities of both companies through an innovative business model that combines Amgen’s pipeline candidates with Astellas’ deep knowledge of Japanese patient and physician needs, long-term commercial and regulatory experience, and strong presence as a leading 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 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 seconded employees from Astellas, transferred employees from Amgen and newly hired employees. It is expected that the joint venture will start operations on Oct. 1, 2013, and will become a wholly owned Amgen affiliate 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 CEO of Astellas. “We will work closely with Amgen to build the joint venture, which will provide innovative medicines to patients in Japan.”
Goldman, Sachs & Co. is acting as financial advisor to Amgen in connection with this transaction. Morrison & Foerster LLP served as external legal counsel to Astellas.
Five Amgen Pipeline Medicines Included in the Amgen Astellas Alliance
|Molecule||Lead Indication||Mode of Action||Development Stage|
|AMG 145||Hyperlipidemia||Anti-PCSK-9 mAb||Phase 3||Phase 2|
|Romosozumab (AMG 785)||Osteoporosis||Anti-Sclerostin mAb||Phase 3||Phase 2/3|
|Gastric Cancer||Anti-HGF mAb||Phase 3||Phase 1|
|AMG 337||Gastric Cancer||MET inhibitor||Phase 1|
Acute Lymphoblastic Leukemia (ALL) and Non-Hodgkin’s Lymphoma (NHL)
|Anti-CD19 BiTE®||Phase 2|
 Developed in collaboration with UCB