Lupin licenses drug delivery technology to Salix for $5 million

India’s Lupin has licensed the rights of bioadhesive drug delivery technology to Salix Pharmaceuticals Inc  of US for $5 million upfront and subsequent milestone payments.

Lupin’s bioadhesive drug delivery technology will be used in Salix new version of bowel drug  Xifaxan, or rifaximin.

Lupin will receive $5 million upfront and milestone payments as the drug advances through clinical development, as well as royalties on potential sales.

Lupin will also exclusively supply rifaximin,the active pharamaceutical ingredient (API) in the Xifaxan, to Salix, as per the terms of the agreement.

Rifaximin is a gut-selective antibiotic with negligible systemic absorption and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens.

Rifaximin tablets 200 mg, which Salix markets in the United States under the trade name Xifaxan (rifaximin) tablets 200 mg, currently is approved for the treatment of patients, 12 years of age or older, with travelers’ diarrhea caused by non-invasive strains of Escherichia coli.

Salix’s Xifaxan is awaiting U.S. regulatory approval for hepatic encephalopathy, a potentially fatal liver disease.

Rifaximin has also been tested successfully in non-constipation irritable bowel syndrome, recently. Irritable bowel syndrome, which includes altered bowel habits with abdominal pain and discomfort, affects about 15 percent of adults in the United States.

Salix expects to win regulatory approvals for Xifaxan in both the indications and be on the market in 2010 and 2011.

Xifaxan cloacked approximately $80 million in revenue for the year 2008.

Salix estimates the non-constipation irritable bowel syndrome market to be potentially worth about $2.2 billion.

Rifaximin has been used in Italy for 24 years and is approved in 33 countries.

Salix acquired rights to market Rifaximin in North America from Alfa Wassermann S.p.A. in Bologna, Italy. Alfa Wassermann markets Rifaximin in Italy under the trade name Normix.

“We believe our proprietary bioadhesive drug delivery technology, which combines controlled-release as well as slowed gastrointestinal transit, would provide an extended release formulation of rifaximin that will be an important component of Salix’s lifecycle management strategy for rifaximin,” stated Nilesh Gupta, Group President and Executive Director, Lupin in a press release.

Next generation rifaximin product incorporating Lupin’s proprietary drug delivery platform  which combines controlled-release as well as slowed gastrointestinal transit, might boost the currrent sales of the drug besides providing a number of clinical advantages including patient compliance and patient convenience, analysts said.

Headquartered in Mumbai, India, Lupin Limited is producing a wide range of generic and branded formulations and APIs for the developed and developing markets of the world.

Besides having leadership positions in the anti-TB and cephalosporins, Lupin has significant market share in key markets in the Cardiovasculars (prils and statins), diabetology, asthma, pediatrics, CNS, GI, anti-infectives and NSAIDs therapy segments.

Lupin is one of the fastest growing top 10 generics players in the two largest pharmaceutical markets of the world — The U.S. (ranked 9th by prescriptions & growing at 92 %) and Japan (ranked 7th and growing at 23%). The company is also the fastest growing, top 5 pharmaceutical players in India (ORG IMS – March 2009) and the fastest growing Generic player in South Africa (ranked 6th and growing at over 30 % YoY – IMS)

For the financial year ended March 2009, Lupin’s Consolidated Revenues and Profit after Tax were Rs.39,145 million and Rs. 5015 million respectively.