Salix Pharmaceuticals, Ltd. announced that the company has entered into an agreement with Cedars-Sinai Medical Center, (CSMC), for the right to use US Patent No. 6,861,053 and US Patent Application No. 11/234,516 relating to methods of diagnosis and treating irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth.
Under the agreement, CSMC grants Salix an exclusive worldwide license to make, have made, use, sell and have sold and import licensed products related to the use of rifaximin, which the company market in the United States under the trade name Xifaxan, with a right to sublicense. CSMC also grants Salix a nonexclusive license to use any unpublished research and development information, know-how and technical data of CSMC as necessary to exploit all rights granted to Salix with respect to rifaximin, with a right to sublicense.
As consideration in the exclusive worldwide license, Salix will pay CSMC a cash license fee and a royalty stream based upon sales after receipt of an U. S. Food and Drug Administration approval on the use of Xifaxan as an indication for irritable bowel syndrome.
This license with CSMC is a strategic part of our Product Life Cycle Management Program focused on Xifaxan. The pending application, if issued, would broaden the scope of the patent protection for Xifaxan.
Xifaxan (rifaximin) tablets 200 mg is indicated for the treatment of patients (>12 years of age) with travelers' diarrhea caused by noninvasive strains of Escherichia coli. Xifaxan should not be used in patients with diarrhoea complicated by fever or blood in the stool or diarrhoea due to pathogens other than Escherichia coli. Xifaxan should be discontinued if diarrhoea symptoms get worse or persist more than 24-48 hours and alternative antibiotic therapy should be considered. In clinical trials, Xifaxan was generally well tolerated. The most common side effects (vs. placebo) were flatulence 11.3 per cent (vs. 19.7 per cent), headache 9.7 per cent (vs. 9.2 per cent), abdominal pain 7.2 per cent (vs. 10.1 per cent) and rectal tenesmus 7.2 per cent (vs. 8.8 per cent).
Salix also markets Colazal, Visicol tablets, Osmoprep tablets, Azasan, Anusol-HC 2.5 per cent, Anusol-HC 25 mg Suppository, Proctocort cream 1 per cent and Proctocort Suppositories. Moviprep and granulated mesalamine are under development.