Bulk drug maker Unimark Remedies is eying an 8-10 per cent share of the global market for at least three drugs that are produced through the biocatalysis route, a greener, cleaner, and more economic way to manufacturing chiral drugs, by 2013-14 when these drugs become generic. The company has set up the first of its kind Biotechnology Center in the country at its Bavla site near Ahmedabad that is dedicated to the research and development of recombinant biocatalysts with an investment of Rs 10 crore.
The Rs 650 crore company that is into manufacturing active pharmaceutical ingredients (API) targets to touch revenue figures of Rs 1500 crore by 2013.
Unimark's Bavla Biotechnology Centre can carry out research using recombinant DNA technology as well as microbial fermentation and biocatalysis of substrate to the desired product. The facility came up with funding from the Department of Science and Technology, government of India that provided a Rs 5 crore soft loan at 3 per cent interest for 10 years and the rest was from internal accruals.
"Nearly 60 to 70 per cent of all drugs will be chiral in nature in the coming years, and the global pharmaceutical industry is now pegged at above $600 billion. We are now into developing three of the popular bulk drugs Atazanavir, an important anti-HIV drug, Atorvastatin, an anti-cholesterol drug and Benazepril, an antihypertensive drug. The global sales figures of these three products are estimated around $1200 million, $14985 million and $1285 million respectively.", said an upbeat Sandip J Parekh, executive director, Unimark Remedies at Bavla today.
Two of these drugs are now under patent; Pfizer sells Atorvastatin under the brand name Lipitor, while Bristol-Myers Squibb(BMS) has the patent for Atazanavir that sells as Reyataz. Lipitor goes off patent in 2011 and Reyataz in 2016, however, Parekh claimed that Atazanavir can be sold in countries of Latin America and Africa where the incidents of HIV-AIDS are very high and the governments can allow compulsory licensing of certain drugs. "The big chunk of the market for Atazanavir lies in these countries and not so much in the US and the EU.", Parekh said.
Unimark will go into commercial production from the first quarter of 2011-12 for Benazepril, and start manufacturing Atorvastatin towards the end of 2011 and Atazanavir from 2012.
The company is,meanwhile, in talks with Israel's Teva Pharmaceutical Industries Ltd that is the single largest consumer of Benazepril for a supply agreement. The drug went off-patent around three years back and now costs around $650 per kilogram in the international market. "We are now making Benazepril through the conventional chemical process and are producing around four tonnes per annum. Teva currently consumes around 9-10 tonnes per annum. Through the biocatalysis process we can offer a cost reduction of at least 20 per cent in Benazepril.", Parekh said. The global market for the drug is around 40-50 tonnes per annum (tpa) and of which around 25-30 tonnes is in the US.
While Unimark's Bavla Biotechnology Centre does the R&D, the company can produce the identified catalyst at its KDL Biotech, a backward integration project at Khopoli in Maharashtra. The drug can then be produced either at Bavla in Ahmedabad or Vapi in Gujarat.
The company is now looking at tying up with innovator companies for product development while it has shortlisted some other products in the anti-infective and anti-diabetic segments where it can develop products through the biocatalysis route.
Interestingly, Ahmedabad based Dishman Pharmaceuticals and Chemicals Ltd entered into a strategic alliance with California based biotechnology firm Codexis, Inc. for a similar technology.
