Kopran Ltd has completed pre-clinical studies of two molecules, code named KNC-6 and KNC-1206. While KNC-6 is an anti-ulcerant, KNC-1206 is a bowel regulator, according to a source close to the company.
The company expects regulatory permission to commence Phase I studies before the end of the year and hopes clinical trials to start in the first quarter of next year, the source said. According to the source, the company has spent around Rs 50 crore so far on its research activities.
Kopran says it will look at out-licensing of the molecules during or after the Phase I studies are completed.
With this, Kopran has joined an elite group of indigenous pharma companies who have pioneered basic drug research in India and filed IND application for Phase I clinical trial. Kopran claims that it is the first company in India to file IND application in the field of gastric disorders.
KNC-6 is a potent dual action anti-ulcer molecule, which has superior ulcer healing properties, compared to marketed drugs such as omeprazole and lansoprazole, the company claims.
Kopran's IND for KNC-6 was filed in March 2002 and is awaiting approval of the DCGI. The IND application for KNC-1206 for permission of Phase I studies will be submitted by the year-end. KNC-1206 is a molecule based on an innovative polymer technology. KNC-1206 has an extraordinary swelling property in the intestine. It swells at least upto 100 times in the intestinal fluid, whereas it hardly has any swelling in the stomach. Due to such selective swellable property, KNC-1206 is regarded as an ideal drug to work not only as a bulk laxative, but also as an anti-diarrhoeal drug and is a novel synthetic alternative to Isphaghula, the company claims.
According to the company, the global market for gastrointestinal drugs is estimated to be $ 13.4 billion by the year 2005. The patent for omeprazole ($ 6.26 billion sales in 2000) has already expired. There is a huge market opportunity for both generic forms of omeprazole as well as for new chemical entities.
The patent for KNC-6 has been filed globally through PCT route in Feb-2000. National Phase filling has already been initiated in USA (Sept, 2001) and 30 other countries including India.
The patent application for KNC-1206 has been filed globally through PCT route in June 2000. US national phase application has been filed in March 2002.
Kopran's research activities have been undertaken by its 100 per cent subsidiary Kopran Research Laboratories Ltd. There are more than 40 people working on various projects of research. The research department would be expanded in a phased manner to meet the objectives, the source said.
The R&D strategy is divided into: (a) focus on discovery of New Chemical Entities; (b) NDDS; (c) process development; and (d) dosage form development. The New Chemical Entities research is based on basic platform technology, which KRL is willing to discover.
Excited by the success of KNC-6, the scientists at Kopran Research Laboratory are exploring the opportunities in several other therapeutic categories. The products in the pipeline include ACE inhibitors, calcium channel blockers. Broad-spectrum antibiotics antiprotozoals, and NSAIDs.
The ongoing research also includes the design and developments of newer reactive polymers, the company said. Kopran is developing a range of polymers under the brand name of Panomer, which could be used for pelletisation and coating. This product is under commercial trials with some selective customers.
Work on some products for NDDS has commenced and the company is also thinking of entering into contract research.
Kopran has also developed several non-infringing processes and filed processes for the same. These include sildenafil citrate, rofecoxib and amlodipine besylate as a unique coating technology for proton pump inhibitor pellets. Kopran is expected to launch sildenafil citrate under the brand name of Nyte as a lifetime product this months itself.
Kopran has two marketing divisions viz. Pharma and a dedicated division for Asthma products viz. KResp. The pharma team focuses on the other therapeutic areas like cardiology, gastroenterology, anti-infectives, pain management and life style products.
It launched a new form of amlodipine besylate that is virtually impurity-free amlodipine in June this year under the brand name Klodip. During the current month, Kopran is launching a new beta-blocker Caditone (carvedilol). In the next quarter, Kopran shall introduce anti diabetic products, the source added.
Vent is the flagship brand of KResp and the product under the umbrella brand of Vent is growing with new products and the total sales of KResp are growing at more than 30 per cent, the source said. Kopran has said that it has no intention of selling any brand and is investing in brand building.