Innovative Joint Venture to Address Unmet Medical Needs of Patients in Japan

THOUSAND OAKS, CA, USA and TOKYO, Japan I May 29, 2013 I 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

Global

Japan

AMG 145

 

Anti-PCSK-9 mAb

Phase 3

Phase 2

Romosozumab

(AMG 785)1

Osteoporosis

Anti-Sclerostin mAb

Phase 3

Phase 2/3

Rilotumumab

(AMG 102)

Gastric Cancer

Anti-HGF mAb

Phase 3

Phase 1

AMG 337

Gastric Cancer

MET inhibitor

Phase 1

 

Blinatumomab

(AMG 103)

Acute Lymphoblastic Leukemia (ALL) and Non-Hodgkin’s Lymphoma (NHL)

Anti-CD19 BiTE®

Phase 2

 

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping people around the world in the fight against serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

About Astellas

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 17,000 employees worldwide. The organization is committed to becoming a global category leader in urology, immunology (including transplantation) and infectious diseases, oncology, neuroscience and DM complications and kidney diseases. For more information on Astellas Pharma Inc., please visit the company website at www.astellas.com/en.

SOURCE: Amgen