Bharat Biotech International Ltd (BBIL), the Hyderabad based biotech firm is set to launch Endurase, the urokinase brand at a price which would be 25-30 per cent cheaper than the average price of the imported products at present. Endurase, the life-saving drug for treatment of acute myocardial infarction (AMI) and pulmonary embolism would be launched by the end of September.
Urokinase, which has fewer side effects compared with Streptokinase, is currently being sold in the country in the price band of Rs 3,300 to Rs 4,000 per 10 lakh international units which is the bare minimum dosage.
With the launch of Endurase, BBIL is also launching a host of high value biotech based products in the country. These products includes a research based Vascular Endothelial Growth Factor (VEGF) for use by cardio thoracic surgeons and Saccharomyces Bolardiae (SB), that prevents inflammation of colon. SB technology has already been developed and the trial runs are on. According to Dr Krishna M Ella, chairman and managing director, BBIL, the product is an improvisation over Sporlac, which is administered along with antibiotic adjuvant.
Bharat Biotech is currently the largest producer of recombinant Hepatitis B vaccine in the country with a capacity of about 100 million doses per annum. The product branded Revac B has reached a turnover level of Rs 24 crore.
The company, which had launched Revac-B, a recombinant vaccine for Hepatitis B as its maiden product in October , 1998 would also launch indigenous Streptokinase, the cheaper alternative for Urokinase in a few months. The domestic markets for these drugs, used for dissolving blood clots in major vessels, are currently catered to by expensive imports.
At present, the aggregate turnover of the two life-saving drugs in India is around Rs 30 crore. Industry experts believe that the market potential is in fact much higher than this. The stagnation in the market is perceived to be due to the high prices of the drugs. The comparatively lower prices of Streptokinase has hence fetched it a turnover of Rs 22-25 crore, whereas sales of only Rs 7-8 crore are reported for Urokinase.
Imported Urokinase is currently being marketed in the country by TTK Pharma, a division of Torrent in the unbranded form , while Otsira Genetica, a division of Aristo, sells it under the brand name Solokinase. Besides, smaller firms such as Mumbai-based V.H.B Pharma, (KD Unase) and Delhi-based Life Medicare & Diagnostics (Medinase) too market imported products in the country. Pharmacia Upjon has recently discontinued marketing of Kabikinase, the brand of Streptokinase in the country. The preset price is in the range of Rs 2000-5000 per dose .
Bharat Biotech has developed both the products in-house using indigenous technology. The company has been assisted financially and technologically by the Technology Development Board with the Union ministry of science & technology for the Streptokinase project.
Dr Ella along with Dr Kuppusamy, vice president (technical), contributed significantly to the indigenous technology project. As of now, animal toxicity trials for Streptokinase is complete and the indigenous product would be launched in India in a few months at a discount of Rs 480-600 against the average price of the imported products, said G M Krishna, GM (strategic marketing). Bharat Biotech will have a capacity to produce 2 million doses of Streptokinase per annum.
Shanta Biotech, which pioneered the vaccine in the country with the launch of Shanvac B has a capacity of 40-50 million doses. A few other companies like Wockhardt is now contemplating the launch of recombinant vaccines for HepatitisB.
Bharat Biotech's manufacturing facilities located at Shamir Pet near Hyderbad conforms to standards of USFDA, MCA of UK and WHO.