The Hindu Business Line : Lupin set to out-license psoriasis drug molecule

Lupin is getting primed to have both its prospective skin-related psoriasis drug molecules licensed out for further development. The Mumbai-based drug company is talking to potential partners who may take Lupin’s herbal and synthetic psoriasis molecules on to complete the cycle of drug development.

There is substantial interest from multinational drug companies, said Lupin’s Chairman, Dr D.B. Gupta, even though the two molecules will be “fit candidates” in another six to nine months. The herbal candidate has completed phase II trials and is set to commence the next phase.

“We have filed for an Investigational New Drug with the USFDA (US Food and Drug Administration),” he told Business Line. The synthetic molecule is undergoing Phase IIa studies, set for completion in another nine moths, he said.

Phase II trials involve trying the prospective drug molecule on people with the illness that the prospective medicine targets, to study its efficacy and safety. If a licensing deal comes through, Lupin will join companies like Glenmark who have undertaken similar strategies and out-licensed prospective molecules developed by them to overseas partners, who in turn seek to complete the development process and bring the drug into the market. But as industry-watchers constantly caution, research has its pitfalls that could derail a prospective drug molecule from successfully reaching the market.

Nevertheless, out-licensing is a method adopted by drug companies after they have established the proof-of-concept stage, where the studies give enough data and reason for a partner to believe that the molecule indeed has the potential to become a good drug.

In such an arrangement, the company out-licensing its molecule usually gets a payment, followed by subsequent milestone payments as the partner achieves significant stages in the development of the drug.

And if the potential drug does get commercialised, then the out-licensing company is entitled to royalty payments as well, besides a division of markets and possibly intellectual property too between the two companies.

Not ready to demerge R&D

But Lupin is not yet ready to walk the research demerger route, as done by companies such as Sun Pharma and Nicholas Piramal. “We will develop more strength in intellectual capital and in a year’s time accumulate good value and high IP. That will be the time to consider this, if we are not able to fund (research through the company),” Dr Gupta said.

Lupin’s research spend stands at 6 per cent of its sales, and this is likely to continue, said Dr Gupta, adding however that the company’s sales have increased and hence the actual amount spent would increase. The company’s revenue for the year ended March 2007 stood at Rs 2,028 crore. And it targets clocking revenues of $1 billion by 2009.

Last year, the company’s investments in research seems to have paid off handsomely, with Lupin getting paid over Rs 200 crore by France’s Laboratoires Servier, in two separate tranches, for the sale of intellectual property related to patents on blood pressure drug Perindopril.

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