Bangalore-based Sami Labs has tied up with the US-based National Institutes of Health (NIH) in the latter's clinical trials study on the effect of Selenomethionine in the treatment of prostrate cancer. The study has entered phase I clinical trials and is expected to be completed by 2010. The effect of Selenomethionine will be studied on 32,400 people. As per the agreement, Sami would be the only supplier of Selenomethionine to NIH till the completion of the study. Selenomethionine is also known as Seleno amino acid.
"Sami Labs will be supplying the compound on the basis of 200 micro-gram per patient per day. The supply would be continued till 2010. We are anticipating a business of $ 200 million from the entire exercise," said Dr. Muhammed Majeed, chairman and managing director, Sami Labs. The first phase of the clinical trials is expected to be completed in 2005.
Selenium is an antioxidant and a cofactor for glutathione peroxidase, an enzyme that is a potent scavenger of oxigen-free radicals. Epidemiological studies In US showed a consistent tend for populations residing in geographic areas that have low selenium levels in the soil to have a higher mortality from cancer. Other studies showed a lower risk for cancer in individuals with higher serum selenium levels. Organic Selenium supplements are preferred compared to inorganic form. Organic sources of selenium such as selenomethionine, selenocysteine or mixtures of organic forms found in brewer's yeast have a better safety profile. Recent research indicates higher doses of selenium can be safely given and may possess additional anticancer activity.
L-Selenomethionine is synthetically extracted from yeast. Sami Labs received the national award for basic drugs in 1994 for the compound.
Sami Labs also tied up with Merryland-based National Cancer Institute (NCI) for doing research on colon cancer with turmeric curcuminoids. The phase I trials of the study is expected to be completed by 2005. "Here too Sami will be the exclusive supplier of curcuminoids. We are looking at a revenue of more than $ 20 million through this tie up initially," said Dr. Majeed.
In either tie-up the company is expected to only supply the compounds (Selenomethionine and turmeric curcuminoids). "The other requirements required in the clinical trials like the lookout of volunteers, patients, hospital infrastructure, monitoring, study, and filing of data will be taken care of by NIH and NCI," he added.
Sami Labs achieved a turnover of Rs. 71 crore for the year ended March 2003 and is hoping to grow by 25-30 per cent over the next three years. Sami Labs' group companies include Sabinsa Corporation (in the US), Organic Aromatics and Anju Phytochemicals.