The world's largest biotechnology company Amgen will start its wholly owned local affiliate companies in Mumbai and Hong Kong before the end of 2006 to tap the Asian market for clinical trials and drug development.
Apart from conducting clinical trials in India, Amgen will conduct R&D operations, including research, pre-clinical development, data management support and statistical programming, by partnering with pharma and biotech companies in India. Currently, Amgen is in talks with some of the leading pharma and biotech companies in India and China to form alliances and collaborations to undertake drug development and clinical trial operations in the Asian region.
"In our industry, R&D is a multi-faceted effort that requires partnerships and collaboration between industry and a variety of individuals and institutions - all committed to advancing human health with the most innovative therapies. In order to conduct clinical studies and apply science and innovation to help fight serious illnesses, Amgen will partner with leading clinicians, as well as academic, healthcare, government, research and patient organisations to better serve unmet medical needs in the region" Mary Klen, associate director, Amgen informed Pharmabiz in an e-mail interview.
However, she declined to share the details of the investment and the companies Amgen is in discussions with to form collaborations and partnerships.
She said under Amgen's global clinical development strategy, the company might decide to develop in Asia any of the molecules that are currently under development in the United States and other parts of the world.
The US$ 12.4 billion Amgen, which invested about US$ 2.3 billion in R&D alone in 2005, has about 26 molecules in the phase I to III stage for the treatment of cancer, asthma, Type 2 diabetes, obesity, pain management, rheumatoid arthritis, CVD and a host of other therapeutic areas.
"The region offers qualified clinical investigators and research professionals, which will enable Amgen to execute clinical trials to gain a better understanding of drug candidates in diverse populations", she noted.
Amgen anticipates that the Mumbai and Hong Kong affiliates will hire about 10 people for each office by year's end. Both offices will be staffed initially with Clinical Development Operations staff. Amgen's affiliate in Mumbai will support the company's clinical trials to take place in India. Amgen's Hong Kong office will act as a regional hub for operations in East Asia, encompassing Hong Kong, Taiwan, South Korea, the Philippines, Thailand, Malaysia and Singapore.
On asked whether Amgen would launch its products in India, she said the company is committed to only conducting clinical studies in countries where there is the reasonable expectation that Amgen or an Amgen partner will commercialise the medicine under investigation. "It is our expectation that successfully developed products will be available commercially to patients in India and East Asia, either from Amgen or an Amgen partner", she said.
Amgen, placed 33rd in Business Week's Global 1200 in December 2005, has research programmes in inflammation, metabolic disorders, and osteoporosis, neuroscience, oncology and haematology. Its research facilities are located in South San Francisco and Thousand Oaks, California; Cambridge, Massachusetts; Seattle, Washington; Cambridge, United Kingdom; and Regensburg, Germany. Amgen operates manufacturing facilities in California, Colorado, Rhode Island, Washington, and Puerto Rico. In early 2006, Amgen announced its plans to invest more than $1 billion to build a new manufacturing facility in Cork, Ireland. Started in 1980 and the pioneer in developing biotech drugs, the company employs more than 18,000 professionals including over 8000 scientists worldwide and has strategic partnerships and alliances with over 100 companies.