Dr Reddy's gets US nod for Prograf generic and expects 20 per cent in FY11 news
After Sandoz, Dr Reddy's Laboratories has become the second company to gain the approval from US regulator to launch tacrolimus capsules, a generic equivalent of Japan's second-largest drug maker Astellas Pharma's Prograf, also sold under the brand name Advagraf by Astellas.
Sandoz, owned by Novartis, was the granted the first-to-market rights after it was approved the US FDA in August 2009.
Tacrolimus is an immunosuppressive treatment used to help prevent organ rejection like kidney or liver in a transplant, and was first approved by the FDA in 1994 for use in liver transplantation. It has now been extended to include kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, bone marrow, and limb transplants.
Dr Reddy plans to launch the drug in the US market next week, Reuters reported quoting a company spokesperson.
Prograf is now available in over 80 countries around the world. This indicates that Dr Reddy's market for this product is huge.
Japan's second-largest drugmaker Astellas Pharma manufactures the drug and introduced it in Indian market last year in June after it established its Indian office.
Tacrolimus is sold under the tradenames Prograf, Advagraf, and Protopic by Astellas and is sometimes referred to as FK-506 (Fermentek catalogue number 506).
Prograf (tacrolimus) is the global leader among immuno-suppressants and is used after organ transplantation.
Prograf (tacrolimus) is similar to cyclosporin, the commonly used drug to stop organ rejection. However, research studies have shown that Prograf (tacrolimus) is much more effective than cyclosporin in equal volumes.
''In FY11, growth will come from US in a large way. ''We expect to launch about 12-13 products and these are the products which are already approved and are awaiting patent expiry. In addition, there could be other approvals like Fondaparinux to come in, so these will drive the growth in the US market,'' said GV Prasad, Vice Chairman and CEO, Dr Reddys Laboratories, in an exclusive interview with CNBC-TV18.
Business in India will grow about 20 percent in FY11, he added.
Dr Reddy's Laboratories recently posted a net profit of 1.7 billion rupees ($37 million) in the quarter to March, its fiscal fourth quarter, compared with a loss of 9.8 billion last year.
May 24, 2010