Japanese drug major Astellas enters India; to launch organ rejection drug Prograf (tacrolimus)

Japan’s leading drug maker Astellas Pharma Inc is planning to establish full-scale operations in Indian pharma market.

Astellas, which is considered number two ethical pharmaeutical company (2008 data) in the world’s second largest pharma market of Japan, already set up its India office last year.

Astellas Pharma India plans to establish business with a capitalization of around JPY 320 million in the Indian market through developing sales and marketing activities of in-house products, the company stated in an official release. Related story: Indian generic makers see opportunities in growing Japan generics market

“India is one of the fastest growing pharmaceutical markets in the world. Driven by a huge patient base, increasing incomes, improving healthcare infrastructure and strong penetration of health insurance, the pharmaceutical market is expected to grow more than double its size in the next five years,” stated Mr. Himanshu Dave, Director-Sales & Marketing, Astellas Pharma India.

Astellas would introduce its innovator flagship product Prograf (tacrolimus)  in India.

Prograf (tacrolimus) is the global leader among immunosuppressants used after organ transplantation.

Prograf (tacrolimus) has similar immunosuppressive properties to cyclosporin, the commonly used drug to stop oragn rejection. However, studies shoed that Prograf (tacrolimus) is much more potent than cyclosporin in equal volumes.

Prograf (tacrolimus) was first approved by the Food and Drug Administration (FDA) in 1994 for use in liver transplantation; this has been extended to include kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, bone marrow, and limb transplants.

Tacrolimus, owned by Astellas Pharma Inc., is sold under the tradenames Prograf, Advagraf, and Protopic. It is sometimes referred to as FK-506 (Fermentek catalogue number 506).

Prograf (tacrolimus) is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants. It is recommended that Prograf be used concomitantly with adrenal corticosteroids.

Prograf is available in over 80 countries around the world.

Astellas’ focus will be to deliver innovative and reliable pharmaceutical products for improving the health of people said Mr. Teruo Yasufuku, Managing Director, Astellas Pharma India. Astella’s is also confident that with the launch of Prograf would pave way for its success and in long-term growth in India.

Astellas would produce innovative products in its globally benchmarked manufacturing facility and technically advanced research and development centre.

Astellas has also plans to further expand its business within Asia with its entry into the Indian market as a footing.

Indian market is currently one of the fast growing markets in the pharmemerging countries. According to the RNCOS report, in near future, the potential and opportunities within this market will increase by several folds. The market, presently driven by over a billion population, an expanding GDP, and rapid epidemiological transitions, is expected to be the major player in the global pharmaceutical market both in terms of its large domestic market and also as a pharmaceutical export hub.

Daiichi Sankya, another leading player from Japan has established in India through acquiring Ranbaxy in a $4.6 billion deal in June last year.

Several players from India also forayed the highly lucrative Japanese market in recent years.

The generic drugs business in Japan is set to grow by 9% from the current less than 5% in the next 3-4 years. Indian generic makers see a huge opportunity as the generics market in Japan is poised to witness strong annual growth of around 9% in 2009-2013 on the back of strong government support and largely untapped nature.

Leading Indian generic players, including Ranbaxy, Lupin, Zydus Cadila and Dishman, have already entered the Japanese pharma market.

Headquartered in Japan, Astellas is a global, research driven pharmaceutical company with sales & marketing organizations, manufacturing subsidiaries spread across the US, Europe, Asia and Japan. In April 2005, the company was formed through the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd.  Astellas Pharma Inc is global category leader in transplant & urology. Astellas had sales of JPY 965 billion in FY 2008 and JPY 159 billion for R&D spending (16.5% of sales).