Amgen will co-develop and co-commercialize five of its pipeline medicines with Astellas in Japan, in the first project of a strategic alliance designed to address unmet medical needs of Japanese patients.
The pipeline medicines range from early to late stages of development, with the first potential commercial launch expected in 2016. Three of the molecules are in Phase III development worldwide, but in varying phases in Japan as indicated below:
AMG 145, an anti-PCSK-9 monoclonal antibody indicated for hyperlipidemia, in Phase II.
Romosozumab (AMG 785), an anti-sclerostin mAb for osteoporosis being developed in collaboration with UCB, in Phase II/III.
Rilotumumab (AMG 102), an anti-HGF mAb for gastric cancer in Phase I.
Also covered by the project are two medicines yet to enter clinical phases in Japan. They include another gastric cancer drug candidate, the MET inhibitor AMG 337, in Phase I worldwide; and blinatumomab (AMG 103), an anti-CD19 bi-specific T cell engager (BiTE®) for acute lymphoblastic leukemia and non-Hodgkin's lymphoma, in Phase II.
In a statement, both companies said their alliance is designed to capitalize on Amgen's drug pipeline and Astellas' knowledge of Japanese patient and physician needs, long-term commercial and regulatory experience, and strong presence in Japan, where the company is headquartered.
"This alliance reflects our long-term commitment to the Japan market and is an important step in our global expansion efforts," Robert A. Bradway, Amgen’s chairman and CEO, said in the statement.
The alliance is the third initiative announced this year, and the second in less than a month, by Amgen toward shoring up its presence in Japan and the rest of Asia. On May 10, Amgen announced plans to commercialize its metastatic colorectal cancer drug (mCRC) Vectibix® (panitumumab) in China through a joint alliance with Chinese-owned Zhejiang Beta Pharma. And in January, Amgen disclosed plans to build a $200 million biologics plant in Singapore, the company’s first Asian manufacturing site.
Amgen and Astellas said they will also establish a Tokyo-based joint venture company through which they will build Japanese-based operations for Amgen. The joint venture, to operate under the name Amgen Astellas BioPharma KK, is expected to start operations on October 1, 2013, and become a wholly owned Amgen affiliate as soon as 2020, with the companies’ long-term collaboration set to continue past then.
Leading the new joint venture as general manager will be Eiichi Takahashi, whose LinkedIn profile describes him as an independent pharmaceuticals professional based in Tokyo. Additional management roles will be appointed by Amgen and Astellas, while employees from both firms and new hires will staff the joint venture’s remaining positions, the companies said.