CD Pharma India has completed phase III randomized double blind placebo controlled trial for induction on remission in mild to moderate active cases of Ulcerative Colitis in the country for VSL#3, a proprietary probiotic product developed from lactic acid bacteria.
The Drugs Controller General of India has approved the product which is expected to be launched in early 2008. The product is for the treatment of mild to moderate ulcerative colitis, which is a serious chronic inflammatory bowel disorder. The product has undergone an extensive trial on 150 patients which spanned for a period of two years at the All India Institute of Medical Sciences, New Delhi, Pushpawati Singhania Research Institute (PSRI) a Super Specialty Hospital for Liver, Renal and Digestive Diseases New Delhi and Dayanand Medical College and Hospital, Ludhiana.
VSL#3 is the only probiotic recommended globally according to the guidelines of the Gastroenterologists Societies of US, Germany and USA. The efficacy of the product is already proven to treat Inflammatory Bowel Disorder (IBD), Irritable Bowel Syndrome (IBS), multiple organ failure, metabolic diseases and Diarrhoeal diseases, including rotavirus. Also trials on humans are in progress to test the efficacy of VSL#3 on obesity related fatty liver diseases, asthma and food related allergies. Another trial involving 500 cancer patients in Italy on radiation induced diarrhoea has also shown promising results. After a successful pre-clinical development, the company had also filed an investigational new drug application.
The New Delhi-based CD Pharma India, which is a wholly owned subsidiary of VSL Pharmaceuticals Inc., is engaged on the formulation development and conducting of clinical trials for VSL#3. Further, the product has also received a certification from the US FDA as being Generally Recognized As Safe (GRAS). The manufacturing and marketing of VSL#3 in India will be outsourced to leading domestic pharma companies, K S Chadha, country manager, CD Pharma India and Director, Asia-Pacific, VSL Pharmaceuticals told Pharmabiz.
Although the key science of the drug has been developed at the VSL Pharmaceuticals' international centres in the US and Italy, the patent has been extended to India also.
The prescription promoted VSL#3 sachet contains 450 billion live bacteria to treat serious conditions. Currently there is no probiotic product for therapeutic use for doctors to prescribe to induce or maintain remission in ulcerative colitis a condition which is largely under diagnosed, said the CD Pharma India chief. The incidence of ulcerative colitis in India and global is around 60 per 100,000 in India which is not too different from the prevalence in the west (which is reported to be around 70-75 per 100,000).
Present probiotic market for therapeutic use in India is valued at Rs 100 crore and registering growth between 30-40 per cent annually. Probiotic products are gaining popularity in the country, he said.
Among the other notable products at the CD Pharma India stable include a range of ethical products for gastroenterology, gynaecology, oral cavity and skin diseases. Under the gynaecology portfolio, the company has developed a proprietary diagnostic method for gynaecologists to differentiate between bacterial and fungal vaginal infections for which the therapeutic product is expected to be launched within the next one year along with the diagnostic device.