Date:18/08/2004 URL: http://www.thehindubusinessline.com/2004/08/18/stories/2004081802070200.htm

Back Glenmark scouting for partner to market new drugs

P.T. Jyothi Datta

Mumbai , Aug. 17

INTERESTING times are ahead for the mid-sized pharma company Glenmark Pharmaceuticals Ltd, with work on two promising drug candidates in the asthma and diabetes segments respectively progressing steadily.

But to market these drug candidates,Glenmark will look for a licensing partner, the company's Managing Director and Chief Executive Officer, Mr Glenn Saldanha told Business Line.

Glenmark's asthma drug candidate, GRC 3886, was scheduled to go in for phase I clinical trials in the UK in July this year.

"We are on course for filing phase I," Mr Saldanha said, unwilling to divulge more details. However, he added, "Clearly we need a licensing partner to take this molecule forward. We would do up to phase II a, which is proof concept in man, and by then, we will have a licensing partner on board."

Phase I trials involve testing the drug candidate on 50 to 100 healthy human volunteers. Glenmark has tied-up with contract research organisation Quintiles for trial of the asthma drug candidate.

A similar strategy will be adopted for Glenmark's diabetes drug candidate. "This molecule will go into phase I trials in the UK by the third quarter (October to December) this year. Subsequently, we will look for a licensing partner for this candidate as well," he said.

"Our model right now is looking at licensing partners, taking compounds to a certain stage of development and out-licensing them. Out-licensing is a phenomenal model because there is an upside for you both financially as well as through IPR (intellectual property rights) and that is the model that most Indian companies are looking at," he said.

Elaborating on conducting phase I trials in the UK, he said, "Looking from the licensing partner perspective, the comfort level is a lot more as you are doing it under a good clinical practices format. Overall, the UK being a regulated market, the comfort level is tremendous vis-à-vis doing the trial in India. What we see typically is companies who have done phase I in India are asked by their licensing partners to go back and repeat the same in a regulated environment. In order to save patent life, we do phase I in a regulated environment."

Milestone payments this year from US initiative

GLENMARK'S US initiative formalised with speciality pharma firm K.V. Pharmaceutical Company in January 2004 is set to bear fruit this financial year.

"We have a partnership with KV for eight products. Out of the eight products, we would transfer technology for four products to KV this year, for which we would get significant amount of milestone payments this financial year. For the remaining four products, tech transfer would happen the next financial year," he said. He was unwilling to divulge the financial details.