Orchid steps ahead on drug discovery path

The Chennai-based Orchid Chemicals & Pharmaceuticals Ltd has achieved a milestone on the drug discovery front.

Its US-based 50:50 joint venture company with Bexcel Pharmaceuticals Inc has completed pre-clinical studies on anti-diabetes molecule BLX-1002 and is set to commence Phase-I clinical trials in November.

Disclosing this to media here today, K Raghavendra Rao, the managing director of Orchid Chemicals, said that the joint venture company would be soon signing an agreement with a Netherlands-based institute to conduct Phase-I clinical trials in Europe.

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"We want to work on our own till Phase II (A) studies -- limited efficacy studies -- on this molecule and outlicense that afterwards for further development. If you outlicense the molecule after completing Phase-II clinical studies, you will have higher scale of earnings that doing at the current stage of initiating Phase-I clinical trials," Rao said.

"BLX-1002 is unique for its anti-weight gain property, efficacy at a very low dose and exceptional safety. Presentations on the molecule at the meetings of American Diabetes Association in July and International Diabetes Federation this month have evoked considerable scientific interest," Rao added.

Orchid Chemicals, in which US-based Schroders Funds and International Finance Corporation holds 32.9 per cent and 13.53 per cent stakes, respectively, has so far infused $2.5 million into its US joint venture out of the total committed amount of $8 million over a three-year period.

"This will take care of our investment requirement till the molecule completes Phase-II (A) clinical studies," Raghvendra Rao added.

Orchid Chemicals has so far filed 4 drug master files (DMFs) with US FDA and planning to file 8 more DMFs and 4 ANDAs over the next 6 months.

While the company has already received US FDA approval for its flagship cephalosporin bulk active Cephalexin, it has just completed inspection process for another product, Cefazolin.

"With our strategic alliance with US-based generics company Apotex to market our antibiotic injectable products in US and Canada, we will be having a significant revenue stream from April 2005. The US FDA-compliant formulations plant set up near Chennai for this purpose is all set to commence production next month," Raghavendra Rao stated.

Orchid Chemicals, which recorded a net profit of Rs 19.5 crore (Rs 195 million) on a sales of Rs 542 crore (Rs 5.42 billion) during last fiscal, hopes to achieve a 40 per cent growth in turnover and more than corresponding increase in net profit during the current fiscal.

"We will touch the Rs 1,000 crore (Rs 10 billion) turnover mark by March 2005 and of that more than 30 per cent will be from regulated markets," Rao added.