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Issue dated - 12th May 2005

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Lupin strikes outlicencing deal with Cornerstone

EPP News Bureau - Mumbai

In only the second such instance by an Indian company, Lupin Ltd has outlicenced a novel drug delivery system (NDDS) for an anti-infective product to US-based Cornerstone Biopharma for clinical development. Earlier, Ranbaxy had out-licensed a NDDS, Cipro, to Bayer a couple of years ago.

NDDS involves reducing dosage in case of tablets from thrice a day to once a day or shifting the administration format from tablet form to injection form for the already commercialised drug. As a part of the development agreement, Lupin will receive, in aggregate, an amount of $10.5 million of which a part is linked to the achievement of certain milestones. Lupin will retain the manufacturing rights and will also receive royalty on sale of the product once it is approved by US FDA. The oral solid anti-infective market in the US represents approximately $10.2 billion where Cornerstone has the rights to sell and market the prescription drug in US upon FDA approval.

Commenting on the new agreement, Lupin chairman D B Gupta said, ‘‘The deal incorporates Lupin’s expertise in development and manufacturing of patented delivery systems, while confirming Cornerstone’s ability to commercialise products in the US market.’’ The stock market reacted positively to the development. The Lupin stock opened at The Stock Exchange, Mumbai (BSE) at Rs 558 and touched a high of Rs 624 before closing at Rs 614.65.

Cornerstone BioPharma is a privately-held, emerging specialty pharma company, with focus on the development and commercialisation of niche prescription medications. It owns the rights to a pain product line, three respiratory product lines, and co-promotes the Suprax anti-biotic.

Lupin had, earlier in January 2005, entered into an alliance with Cornerstone through its wholly-owned subsidiary to co-promote Suprax (cefixime) anti-infective. As part of the agreement, Cornerstone’s sales force are co-promoting Suprax, approved in 2004, with a focus on primary care physicians, who were not covered by Lupin.

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