A joint venture in Japan

THOUSAND OAKS, Calif.—In an effort to address some of theserious medical needs faced by patients in Japan, Amgen and Astellas PharmaInc. have initiated a multi-pronged strategic alliance, combining certain ofAmgen's drug candidates with Astellas' established familiarity with Japanesemarkets as a leading company in the area. Astellas was founded in Japan, withits headquarters in Tokyo, and Amgen has a growing presence in the region witha subsidiary in Tokyo.

The Japanese pharmaceutical industry is the world's secondlargest and was worth approximately $89 billion in 2011, roughly 10 percent ofthe global market share, according to a report from GBI Research.

"Through this alliance, Amgen will work closely withAstellas to leverage its extensive knowledge of the local market," Robert A.Bradway, chairman and CEO of Amgen, said in a press release. "With Astellas'strong capabilities and excellent reputation, this alliance will help acceleratedevelopment and commercialization of Amgen medicines for patients in Japan.This alliance reflects our long-term commitment to the Japan market and is animportant step in our global expansion efforts."

One factor of this alliance is a long-term collaborationbetween Astellas and Amgen for the co-development and co-commercialization inJapan of five Amgen pipeline medicines. Among the selected drug candidates areAMG 145, an Anti-PCSK-9 mAb being developed for the treatment ofhyperlipidemia; AMG 785 (developed in collaboration with UCB), ananti-sclerostin mAb indicated for the treatment of osteoporosis; AMG 103, ananti-CD19 BiTE being developed for the treatment of acute lymphoblasticleukemia and non-Hodgkin's lymphoma; AMG 102, an anti-HGF mAb, and AMG 337, aMET inhibitor, both of which are indicated for gastric cancer. The compoundsrange from Phase I to Phase III development, and the first commercial launch isexpected as early as 2016.

The second element of the partnership consists of theestablishment of a Tokyo-based joint venture company. Astellas and Amgen willwork together through the joint venture to aid Amgen in rapidly developingon-the-ground capabilities in Japan. The joint venture will be operating underthe name Amgen Astellas BioPharma KK, with Eiichi Takahashi serving as generalmanager and additional management roles to be appointed by the two partners.Amgen Astellas BioPharma KK will be staffed by seconded employees fromAstellas, as well as transferred employees from Amgen and newly hiredemployees. Operations for the joint venture are expected to begin Oct. 1 ofthis year, and the site will become a wholly owned affiliate of Amgen as earlyas 2020, with the long-term collaboration continuing.

No financial details for the alliance were disclosed.

"We look forward to entering this alliance with Amgen andbelieve it will strengthen our pipeline to address unmet medical needs, as wellas enable us to obtain growth drivers," Yoshihiko Hatanaka, president and CEOof Astellas, commented in a statement about the arrangement. "We will workclosely with Amgen to build the joint venture, which will provide innovativemedicines to patients in Japan."

Amgen brought on Goldman, Sachs & Co. as its financialadvisor in conjunction with the agreement, while Astellas enlisted Morrison& Foerster LLP as its external legal counsel.

The alliance follows another large partnership announced byAstellas in April. The company joined Daiichi-Sankyo Co. Ltd., Eisai Co. Ltd.,Shionogi & Co. Ltd. and Takeda Pharmaceutical Co. Ltd., as well as the Bill& Melinda Gates Foundation and the Japanese government, in forming GlobalHealth Innovative Technology, a public-private partnership dedicated to helpingdeveloping countries in the fight against infectious diseases. The initiativewas heralded by the participating companies as the first of its kind in Japan.