City-based mid-sized pharma player Unimark Remdies has altered its earlier product pipeline of producing an anti-hypertension and anti-cholesterol drug, to focus on developing the active pharmaceutical ingredients (API) of a widely selling anti-biotic amoxycillin through the biocatalysis process.
Unimark had earlier planned to start production of Atorvastatin, an anti-cholesterol drug, from the end of last fiscal. The company, however, has dropped the plans, and as Sandip J Parekh, executive director, Unimark Remedies puts it, "Going by the market dynamics, we thought it would be prudent to wait for sometime before we start making Atorvastatin. The market for the drug has become too competitive."
Atorvastatin's market size is estimated to be around $13 billion (Rs 7429 crore) globally. The cholesterol lowering drug from Pfizer under the brand name of Lipitor has gone off-patent in November 2011. Now the market is open for players like Teva Pharmaceutical Industries, Mylan, Dr. Reddy's Laboratories, Aurobindo Pharma, Actavis Group among others who are scrambling for grabbing a share of the pie. Teva recently said that it has dropped plans to make Atorvastatin formulations for the moment.
"We are now thinking of developing our own generic application for Atorvastatin, but would wait for the right time to start production", Parikh said. Plans of starting production of another drug in Umimark's pipeline, Benezepril, has also been put on the back-burner. Unimark was in talks with Teva for supplying the API of the above mentioned anti-hypertension drug. "The average approval time for US Food and Drugs Administration (USFDA) is around 26 to 32 months now. And with this kind of a bottleneck, formulations companies are now deciding their priorities as to which drug they want to launch in the market first. Teva has not shown much interest in Benezepril off late, and hence, we have not gone ahead with the production of the API", Parikh explained.
Unimark, instead, has decided to focus on developing the API for amoxycillin, a widely used antibiotic, through the biocatalysis process. The biocatalysis technology, a greener, cleaner, and more economic way to manufacturing chiral drugs, reduces production costs by 25-30 per cent. Chiral drugs comprise nearly 60-70 per cent of the global pharmaceutical industry. "DSM is the only international company that makes amoxycillin using the enzymes route, all others use the chemical process. We will have a major competitive edge over other producers, as through the biocatalysis route, we can offer the API at a much cheaper rate", Parikh claimed.
This apart, Unimark is also working on developing certain intermediates that go into anti-biotic production.