Ind-Swift Laboratories Ltd. is launching an anti-diarroheal molecule 'Nitazoxanide' for the first time in Asia. This is the first molecule approved by the US FDA in last 40 years and is the only drug approved for the treatment of Diarrhea caused by Cryptosporidium parvum in children aged between 12 month and 11 years. The molecule is being launched in India by the company within a year of its global launch by the originator. The company has recently obtained the approval from the Government of India for the launch of this drug in India, a release stated.
Speaking on the occasion, V.K. Mehta, joint managing Director said, "Launching of Nitazoxanide is a part of the company’s business plan of introducing products in India for the first time." Ind-Swift targets sales of over Rs10 crore in the very first year of its launch and a growth by 50 per cent over next three years when the company sees the sales figure touching Rs 35 crore. It is also launching the drug in the Latin American, Asian and African markets.
"Most of the available therapies have low cure rates, low resistance, frequent dosages and the duration of the treatment is also long which are not patient convenient and cost effective," Mehta added. He also disclosed that Nitazoxanide is relatively a more effective drug developed in-house by the company’s R&D team. It is a three-day therapy against the conventional therapy of one week.
Romark Laboratories, the originator for this molecule under the brand name Alinia have predicted the U.S. market size of this molecule to be US$100mn in the first year with expected annual growth rate of over 40 per cent. The U.S. market is also expected to grow substantially on the back of the originator entering into strategic marketing tie-up with Cardinal Health, a fortune 500 company.
The company has recently filed 1 DMF with US FDA and 2 Common Technical Documents (CTDs) with European authorities. In addition it has already filed 2 new patents and its R&D is in the process of developing non-infringing processes for 4-6 new molecules.
In addition to the existing 15 products, the company has 20 new products in the pipeline whose combined global sales were about US$25bn in 2003. Ind-Swift Laboratories aims to be among the first three Indian companies to launch them.