Astellas Pharma India Pvt Ltd, the Indian subsidiary of the Japan's second largest drug major, Astellas Pharma, is working on a marketing strategy of spreading public awareness on organ transplantation and cadever organ donation along with intensive campaign among specialists to establish a market for its flagship immunosuppressant product - Prograf - in the country.

The company is in the process of recruiting its sales team, with a staff strength of 10 to 15, and is in talks with some of the non governmental organisations (NGOs) in healthcare sector including the Indian Society of Organ Transplantation to establish Prograf in Indian market. Prograf, the world's best-selling drug used to stop transplanted organs from being rejected, is planned to be commercialised in the country by the first quarter of next financial year, informs Teruo Yasufuku, managing director, Astellas Pharma India.

"The awareness on cadever organ donation is very little in India, like many other countries, and we will be working with the NGOs to spread awareness among public probably from the time of our product launch. At present the market is dominated by generic products and we expect that our product would become the market leader in the transplantation segment in coming years," said Teruo. However, he refused to divulge more on the marketing strategy commenting that the model is yet to be finalised.

The company is expecting a major challenge from the generic equivalents of Prograf, at a time when Sandoz, the generic arm of Novartis AG has launched the first generic tacrolimus product in August, 2009. Astellas' plan is to grab the Indian transplantation market through the specialist doctors. The company expects major sales from the Chinese and Indian pharmaceutical market in the coming years, avered the official.

There are around 150 hospitals in India conducting organ transplantations, mostly based in urban area, and around 4000 transplants have been taken place in the country, as of now. The growth rate of organ transplantation is 15 to 20 per cent and the increase in awareness would provide more room for Prograf to play a role in the Indian business of Astellas, said Teruo.

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

Prograf (tacrolimus) was first approved by the US FDA in 1994 for use in liver transplantation which 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. 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.

The product has been enjoying the top ranks in the segment in the US market till it lost the patent protection. According to IMS Health, Prograf had US sales of US$ 929 million for the 12 months through April 2009.