Morrisville, North Carolina-based Salix (NASDAQ:SLXP) in 2009 licensed the drug delivery technology from Mumbai, India-based Lupin Pharmaceuticals. Salix uses that technology in its gastrointestinal drug rifaximin, marketed as Xifaxan. Salix announced Wednesday that Lupin has now granted Salix exclusive worldwide rights, outside India, to use that technology and any technology jointly developed by the companies for all rifaximin products for human use.
The 2009 pact gave Salix only U.S. rights to the technology, which allowed for the development of an extended release rifaximin product. At that time, the only U.S. Food and Drug Administration-approved indication for the rifaximin was treating traveler’s diarrhea. Rifaximin is a gut-selective antibiotic with broad spectrum activity against a range of pathogens.
Salix has since been looking to add to the number of indications for the drug. The company last year received approval on rifaximin for treating hepatic encephalopathy, a brain disorder associated with severe liver disease. Salix has also been seeking to add nonconstipation irritable bowel syndrome as a new indication. The FDA in March informed the company it could not approve that application in its current form and Salix said it would meet with FDA officials before determining its next steps.
With the new agreement, Salix must now make a $10 million up-front payment to Lupin. Additional payments could come if the company hits U.S. regulatory milestones for products covered by either Lupin patents or patents jointly held by the companies. Salix must also pay royalties on any sales, as well as quarterly payments for product development.
- Drug approval now unlikely for Salix bowel treatment (medcitynews.com)
- Salix gets FDA letter on IBS drug, but company won’t disclose details (medcitynews.com)