Bangalore-based Sami Labs has received approval from US FDA for its cholesterol lowering herbal extract Gugulipid for conducting preclinical studies. The studies on the lead compound are expected to be completed by April 2004.

Sami Labs sister concern Sabinsa Corporation will invest $ 200,000 for the IND phase of the clinical trials. Already we have completed first two levels of trials within IND phase and the results have been positive, informed Dr. Muhammad Majeed, chairman & managing director, Sami Labs.

"The final phase for clinical efficiency will be initiated at Mercy Research Centre, New York, which will be completed by April 2004," he said.

According to him even though the first level of trials had been controversial, the subsequent trials showed positive metabolic effects from Gugulipid, which will be published in a report in November.

Gugulipid is an extract of the exudate (gum guggul) of Mukul myrrh tree (Commiphora mukul) containing phytosterols named guggulsterones, organic acids, aromatic acids, diterpenes, lignans, and fatty acid alcohols. It is well known in the western world as a quality herb grown in India used in Ayurvedic products.

Central Drug Research Institute, Lucknow has pioneered the study of Gugulipid in India.

Although it has been widely used in Indian and western nutraceuticals products, it is for the first time the cholesterol lowering effects of the compound being studied with US FDA approval.

Subsequent to this approval, Sami Labs becomes the second Indian herbal drug company after Zandu receiving US FDA approval to conduct clinical studies on an herb based active ingredient.

Zandu Pharma, way back in 1999 had received investigational new drug status from US FDA on HP-200, an active ingredient sourced from Mucuna pruriens, a plant belonging to leguminous family in the treatment of Parkinson's disease.

Once the pre-clinical studies are over, Sami Labs would like to tie-up with some foreign firms for further development of the drug, said Dr. Majeed.

The current global anti-cholesterol drug market is estimated to be around $ 20 billion and is growing at an annual rate of 10 per cent. The lead molecule in the segment is Pfizer's Lipitor.

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. The company has offices spread across Japan, China, Dubai, Europe apart from the US. The group's product portfolio includes nutraceuticals, standardised herbal extracts, fine chemicals, cosmeceuticals, probiotics and various enzymes.