Panacea Biotec, India's second largest vaccine producer, has entered into a strategic alliance with Kremers Urban Inc. (part of UCB Group) for 11 high barrier to entry generics, whose market size in US at the innovator level is around US$ 4 billion.

The first product in this portfolio to reach the market is Tacrolimus Capsules that is being launched in US in November 2012. Panacea Biotec was granted approval of the product from the United States Food and Drug Administration (FDA) in September 2012. Tacrolimus is used along with other medications to prevent rejection (attack of a transplanted organ by the immune system of a person receiving the organ) in people who have received organ transplants. Tacrolimus is in a class of medications called immunosupressants. It works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ.

The total market size of Tacrolimus is approximately $892 million in US. Currently there are five generic players in US; namely Sandoz, Dr Reddy's, Mylan, Watson and Accord Healthcare. The innovator brand Prograf accounts for approximately 43 per cent of Tacrolimus sales in terms of units sold and generics account for the remaining 57 per cent.

Commenting on the development, Dr Rajesh Jain, joint managing director, Panacea Biotec said, “Panacea Biotec's proven track record in building strong, collaborative working relationship is a key driver for this strategic alliance with Kremers Urban that will accelerate the company's growth plans in the US. Approval of Tacrolimus from US-FDA is the first milestone achieved in Panacea Biotec's long term plan for USA; the largest pharmaceutical market in the world. This would be followed by a series of high barrier to entry generic product launches that are being developed by the company. The commercialization strength of Kremers Urban for high barrier to entry generics perfectly synergizes with Panacea Biotec's research, development and manufacturing capabilities for such complex products forming a true win-win strategic alliance.”

Under the terms of the agreement Panacea Biotec would be responsible for research, development, registration and commercial supplies of the products while Kremers Urban would be responsible for marketing, sales and distribution. The business collaboration is based on long term profit sharing by both companies.

Submission of the first Abbreviated New Drug Application (ANDA) within this basket of 10 additional products was done in September 2012. The remaining 9 ANDAs would be submitted with USFDA over the next 16 months' time period.

Panacea Biotec is a research-based health management company. The product portfolio of the company includes products in important therapeutic areas such as pain management, diabetes management, renal-disease management, anti-osteoporosis, anti-tubercular, gastro-intestinal care products and vaccines.