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CSIR’s molecule success gives a big boost to public research

18 November 2010

A key molecule to treat heart disease—developed at a government lab and slated for the market in 2012 if human trials are successful—could change the way public research institutes approach drug discovery.

The clot-specific streptokinase has cleared crucial trials on monkeys in the US, according to Girish Sahni, director of Chandigarh-based Institute of Microbial Technology (IMTech), where the drug was developed.

“If the next phase III (human) trials are successful by 2012, it would be a great success,” Sahni said.

IMTech, which operates under the Council of Scientific and Industrial Research (CSIR), exclusively licensed the streptokinase molecule to Nostrum Pharmaceuticals Llc, a US-based firm, in 2006, in a first-of-its-kind deal involving publicly-funded labs.

Although the licensing fee of Rs.25 crore is minuscule compared with the billions a blockbuster drug earns for pharma firms, it is for the first time that a state-run lab has tried extracting a relatively higher price for a molecule it developed.

“Typically, we’ve never got more than Rs.5-10 crore for licensing molecules,” said G.S. Prasad, an IMTech scientist associated with streptokinase’s promotional efforts. “So this is a big and encouraging deal that could change the dynamics of molecule development in public labs.”

CSIR, India’s largest scientific organization, has developed several drugs in its 68 years of existence, but has mostly given them out to local companies on a non-exclusive basis. This meant it rarely earned much money from licensing fees, considered the mainstay of research and development firms.

Prasad said drug companies in India generally expect state research organizations to give away molecules for paltry sums. “They say, you are publicly funded. You have no profit targets to meet. So why do you need money?” he said. “That mindset has to change.”

Sahni said CSIR, which holds the largest number of patents in the country, spends a substantial amount of money in filing and maintaining them.

“We don’t have to make money from everything, but high-value patents ought to generate revenues,” he said. “That’ll only help better research and benefit the country.”

Although the new molecule had been licensed to a US firm, it is aimed as a lower-cost product.

“The current state-of-the-art called TPA (tissue plasminogen activator) costs Rs.50,000 for a single injection,” Sahni said. “Our product is also a single shot and will be less than Rs.10,000. So exclusive licensing doesn’t necessarily mean exorbitant prices.”

Experts say medical treatment isn’t confined to chemical drugs and the future could belong to biologics, which includes vaccines and recombinant DNA therapies that promise safer and more effective solutions.

“It’s relatively difficult to spin off a generics industry on biologics than it is to develop chemical drugs,” said Vinay S., a molecular biologist at the University of Delhi. “And that’s largely because of the science and manufacturing process of biologics.”…….

Read more: http://www.livemint.com/2010/11/17211504/CSIR8217s-molecule-success.html?atype=tp

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Written by csirindia

November 18, 2010 at 8:31 am

Posted in IMTECH

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