TOKYO – One more Japanese company has taken a step closer to the biosimilars market through a strategic drug development alliance with a U.S. company and a drug for rheumatoid arthritis.
Daiichi Sankyo Co. said it would begin phase III trials in Japan for CHS-0214, an investigational etanercept biosimilar for rheumatoid arthritis. Daiichi Sankyo is a co-sponsor of the trial with Coherus Biosciences Inc., of Redwood City, Calif.
It marks the latest in the growing number of strategic development alliances between foreign and Japanese pharmaceutical companies. Japan's improved regulatory environment and faster approval times for new drugs has also helped spur such partnerships.
"We developed the medicine with Coherus because we wanted to produce it quickly, and we felt that they were the best. When it's approved, Coherus will first manufacture it in the U.S., then we follow and manufacturer it here," said Michicko Igarashi, a spokeswoman for Daiichi Sankyo.
Longtime Japanese pharma industry watcher and president of International Alliances Limited, Reed Maurer, said Japan does not really have the capabilities to develop biosimilars so many companies are looking to join forces with foreign countersparts.
"They need to form alliances outside Japan, not just with U.S. companies, so they can grow," Maurer said. "They were not interested in biosimilars six months ago, but they are now, particularly because the original drugs are going off patent. Biosimilars could be the next big market."
Maurer said that is another example of Japan reaching out beyond its borders. The nation is the second largest pharmaceutical market in the world.
A new research program by Japan's Ministry of Health, Labour and Welfare (MHLW) that will kick off next year also has highlighted the importance of those partnerships. The program is modeled after a U.S. government project in which 10 companies, including Pfizer Inc., and Sanofi SA and Takeda Pharmaceutical Co. Ltd., developed drugs as part of a collaboration between the private sector, government and academia. The aim of the program in the U.S. is to increase the efficiency of new drug R&D by sharing costs and human resources.
MHLW's FY2015 Budget Request is a record ¥31.67 trillion (US$305 billion), which includes ¥56.6 billion for Japan's Agency for Medical Research and Development. Those funds will be used to promote research in areas such as Alzheimer's disease and type 2 diabetes.
The MWHL said teaming multiple universities, national research centers and drugmakers will enable product development that a single university and company could not handle on their own.
The phase III trials for rheumatoid arthritis that Daiichi Sankyo launched this month add to similar trials launched in June 2014 by Coherus.
The CHS-0214 trial is a randomized, double-blind, active-control, parallel-group, multicenter, global study that compares the efficacy and safety of the biosimilar with its originator compound, Amgen Inc.'s Enbrel (etanercept), in patients with active rheumatoid arthritis who have shown inadequate response to methotrexate. The primary endpoint is a 20 percent decrease in swollen joints and tender joints at 24 weeks.
Daiichi Sankyo said rheumatoid arthritis affects more than 700,000 people in Japan and more than 23 million worldwide.
It is a chronic and progressive autoimmune disorder in which the immune system mistakenly attacks its own body's tissues, resulting in inflammation, particularly in small joints in hands and feet. The result is a painful swelling and sometimes permanent deformity. Treatment focuses on controlling symptoms and preventing joint damage.
Despite the availability of treatments, up to one-third of patients fail to respond and as many as half of patients stop responding altogether to disease-modifying antirheumatic drugs (DMARDs). Daiichi Sankyo was established in 2005 through the merger of Daiichi Pharmaceutical and Sankyo. The firm has 30,000 employees worldwide and develops, manufactures or distributes both brand name and generic medicines in more than 50 countries around the world.
Coherus, founded in 2010, is a late-stage clinical biologics platform company focused on the global biosimilar market. The company is focused on the development, manufacture and commercialization of biologic therapeutics, primarily for the treatment of oncology and inflammatory diseases.
The company's partnerships include global pharmaceutical companies in Europe, Asia and Latin America.