Ind-Swift launches Nitazoxanide an anti-diarroheal drug for the first time in asia
True to its name of being SWIFT in launching new molecules at a fast pace, the leading bulk drug manufacturer exporter Ind-Swift Laboratories Limited is launching an anti-diarroheal molecule ‘Nitazoxanide’ for the first time in Asia. This is the first molecule approved by the FDA in last 40 years for Gardia and is the only drug approved for the treatment of Diarrhea caused by Cryptosporidium parvum in children aged 12 month to 11 years of age. 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 DCGI approval for the launch of this drug in India.
(PRWEB) August 11, 2004
True to its name of being SWIFT in launching new molecules at a fast pace, the leading bulk drug manufacturer exporter Ind-Swift Laboratories Limited is launching an anti-diarroheal molecule ‘Nitazoxanide’ for the first time in Asia. This is the first molecule approved by the FDA in last 40 years for Gardia and is the only drug approved for the treatment of Diarrhea caused by Cryptosporidium parvum in children aged 12 month to 11 years of age.
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 DCGI approval for the launch of this drug in India.
Confirming the news Mr. V. K.Mehta told that “launching of Nitazoxanide is a part of Company’s business plan of introducing products for the first time in India”. He said that “ 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.” He disclosed that the Nitazoxanide is relatively a more effective drug developed in-house by the Company’s R&D which is a 3 day therapy against the conventional therapy of one week.
Romark Laboratories the originator for this molecule under the Brand name Alinia have predicted the US market size of this molecule to be US$ 100 millions in the first year with expected annual growth rate of over 40% . The US market is also expected to grow substantially on backdrop of the Originator entering into strategic marketing tie-up with Cardinal Health, Inc. a fortune 500 Company.
Ind-Swift which already has a thrust on the exports and is present in 40 countries across the globe, targets a sales of over Rs. 100 millions in the very first year of its launch and a growth by 50% over next three years when the Company see the sales figure to touch Rs. 350 millions. The Company is equipped for the launch of the drug in the Latin American, Asian & African markets.
Ind-Swift laboratories limited is a one of the largest manufacturers of the API and advanced intermediates in Domestic and International market. It has recently built up large scale capacities for all the Complex molecules where it is present. Over the last few years, ISLL has shifted its focus to complex molecules and development on non - infringing processes, so as to minimize the risk of severe competition and commoditisation. The company has launched and built global scale capacities in several high potential molecules like Clarithromycin, Fexofenadine and Atorvastatin – ISLL is in fact the largest producer of Clarithromycin (around 15% of global capacity) and Fexofenadine in the World after the innovators.
The company is also among the first few players to launch other complex products like Clopidogrel, Candesartan, Atorvastatin, Pioglitazone and Citalopram. ISLL has invested around INR 250 mn over the last three to four years to build capacities (it now has six manufacturing plants) and make its facilities cGMP compliant and approvable by regulatory bodies like the US FDA and UK MCA. The company has already filed its first DMF in the US market and expects it to be ready for US FDA inspection over the next few months.
As per IMS Mat December 2003 the Indian market size for the Anti-infective segments which includes the important therapies of Anti-Diarroeheal, Anti-Amoebicide, Anti-helminths, Anerobicides, Trichomonacides is over Rs. 5190 millions. Out of this total market, molecules Tinidazole and Metronidazole alone accounts for the 63% of the size and both these molecules are de-growing. Nitazoxanide would have a direct impact on the sales of these molecules. Moreover clinical trials and comparative studies are underway for albendazole or mebendazole. Nitazoxanide is also a boon for the immuno-suppressants patients and HIV patients where trials are underway.
The next new launches planned by the Company includes an Anti-Alcoholic drug (sales of US$ 16.2 mn in Europe), a molecule for Breast Cancer (a US$ 100mn product). Besides the company is also going to launch two molecules from Statin range, which include an Anti-Hyperlipidemic drug with World market of over USD 5 bn by 2005. 3 of these new products are slated to be commercially launched during the current quarter.
The company has recently filed 1 DMF with USFDA and 2 Common Technical Documents (CTDs) with European authorities. In addition ISLL 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 existing 15 products, the company has 20 products in pipeline whose combined global sales were approximately USD 25 bn in 2003 and ISLL envisages being among the first three Indian companies to launch them.
ISLL is in fact the only company in the world apart from the innovator (Abbott) to have developed Clarithromycin granules, and was also the first to develop Roxithromycin granules. The R&D of the Company is ready with four new patents. These are patents for non - infringing processes of an Anti-Diabetic, Cardiovascular, Anti-Histamine & Antibiotic drug respectively. All these drugs are scheduled to be launched in the financial year 2004-05.
The company has recently set up a subsidiary in US and has also recruited top officials for the same. The new outfit would essentially seek Custom Research, Custom Manufacturing arrangements and strategic partnership in the US market. The Company has already tied up with four US companies, which figure among the top 15 Companies in the US, for supply of its products.
Ind Swift Laboratories Ltd (ISLL) is an emerging API player, with a clear focus on positioning itself as a primary supplier of bulk drugs to regulated markets. Hitherto focused on unregulated / soft regulated markets, ISLL has been steadily building a platform for a foray into regulated markets – the company has invested heavily in manufacturing and R&D infrastructure, and efforts are also on to develop a front end in the target markets. With six cGMP compliant plants and a robust product basket of 18 molecules (20 more in the pipeline), ISLL is well set to reap the rewards of its initiatives over the next few years.
ISLL has built a full fledged R&D centre with a team of around 70 people, which is clearly focused on developing new drugs and non infringing processes for the same. The company has strong process chemistry skills, which helps it develop cost effective and complex processes for various APIs and intermediates. The R&D efforts have led to successful commercialization of 18 products so far, while around 20 are in the pipeline to be launched over the next two to three years.
