Glenmark bets big on novel biologics

Glenmark Pharmaceuticals is diversifying its activities in a big way to develop novel biologics products.

The company is the country's first pharma firm to outlicense two of its novel chemical entities in Phase II to Forest Labs, Teijin Pharma and Merck, plans its biotech drug pursuit initially with development of bio-improvics and then focus on development of novel biologics.

It has already commissioned a laboratory at its biologics research facility in Switzerland with over 15 to 20 scientists, and it expects some of the new drugs to come out by next year. It also plans are to make at least one biologics target into Phase I by 2009.

"Our focus in the biotech research segment will be on novel biologics and not bio-similar products. Glenmark is a research-driven company and we believe our team has the capability and skillsets to develop biotech drugs, though comparatively a higher risk proposition," said Glenn Saldanha, managing director and CEO.

He added the company is investing to build capacity at the biologics facility in Switzerland by 2010. Saldanha declined to disclose further details.

Commenting on the NCE research, he said the company was in advanced discussions with a few multinational drug majors to outlicense its third molecule under development, the GRC 6211 for osteoarthritis, dental and neuropathic pain and urinary incontinence.

The drug is currently undergoing Phase I trials and the deal would be announced shortly. Glenmark's obesity drug GRC 10801 is also scheduled to enter Phase I trials within one or two months, and the PDE4 inhibitor for rheumatoid arthritis and inflammation is likely to enter pre-clinical stage by mid-2008.

"We have a pipeline of six molecules with in the Phase II, one in Phase I and three in the pre-clinicals. We are excited about the feedback on Oglemilast and hope to launch the drug by 2010. We hope to ensure at least one molecule enter into the clinical stage every year from now onwards. NCE research focus will be on metabolic disorders and inflammation," he said.

Glenmark is also discussing with a few pharma majors to outlicense Oglemilast, the diabetic molecule, for the European market.

The drug is currently undergoing Phase IIA trials, undertaken by outlicensing partner Forest Labs. Top line data for exercise induced asthma is expected soon and Forest Labs have to respond to US FDA queries for pursuing Phase IIB trials.

The company is also planning to strengthen its European branded generics and formulation business through the inorganic route "� at least an acquisition every year.

The company is on the verge of concluding acquisition of a $200 million generics manufacturing unit in Central Europe. Funds would be generated internally and only the formalities are pending. Future targets include front-end branded generics companies in countries like Spain, Italy, Central and Eastern Europe.

Similarly, Glenmark is evaluating acquisition targets in the region of Russia, CIS and African continents.

In the US, Glenmark and its marketing partners have filed about 38 ANDAs, focusing on controlled substance category and dermatological products. About 12 generics are already in the market and three more will be added this year.