Amgen to begin clinical trials next year in India

Amgen, the US-based $12.4 billion biotech major, will begin clinical trials in India through its local affiliates next year.

The company expects to begin enrolment for these trials in 2007. The R&D pipeline includes therapeutic areas such as metabolic disorders, oncology, neuroscience and inflammation among others.

Amgen is forming local affiliate companies in Mumbai and Hong Kong that will have the capability to coordinate with clinical research organisations to conduct clinical trials in India and East Asia.

"The initial activities in Hong Kong and Mumbai will focus primarily on enrolling and conducting clinical trials for several Amgen investigational products. Enrolment in these trials is expected to begin in 2007," a senior company official said.

Amgen has nine molecules undergoing phase III clinical trials meant to investigate the safety and efficacy of a potential drug in a large number of patients who have the disease under study. It has six clinical trial candidates in phase II and 12 in phase I category.

While phase II clinical trials investigate the side effects and efficacy of a product in a large number of patients, Phase I studies the safety and proper dose ranges of a product candidate in a small number of humans.

"We expect to grow our operations in both countries over the next several years but cannot provide specific growth projections at this time" the company said in an email response.

"The investigational therapies that will be developed in Asia are also being developed in the US and other parts of the world. Under Amgen's global clinical development strategy, the company may decide to develop in Asia any of the molecules that are under development in the US and other parts of the world," according to the company.

"Asia offers highly qualified clinical and research professionals, as well as large and diverse patient populations that could benefit from Amgen's therapies. Amgen is committed to only conducting clinical studies in countries where there is the reasonable expectation that Amgen or an Amgen partner will commercialize the medicine under investigation".

Terming Amgen move as its single greatest R&D expansion since the company's founding in 1980, Klem stated that the R&D expansion 'is due to a remarkably robust pipeline'.