Shares of Salix Pharmaceuticals rose 14.5 percent on announcements of positive results in clinical trials of two products, a copromotion agreement and a patent licensing deal.
Top-line results from a Phase IIb efficacy and safety trial of rifaximin in the treatment of diarrhea-associated irritable bowel syndrome (dIBS) showed that the protocol-specified, intent-to-treat, co-primary endpoint comparison of a 14-day course at 550 mg twice daily provided a statistically significant improvement in both adequate relief of dIBS symptoms and adequate relief of bloating, compared to placebo. The company said it expects to meet with the FDA later this year and begin Phase III trials in the first quarter of 2008.
The company also announced the successful completion of the first of two Phase III registrational trials on the safety and efficacy of its new granulated mesalamine product under development for maintenance of remission in patients with ulcerative colitis. Study results indicated that a statistically significantly greater proportion of subjects dosed once a day with 1.5 grams of granulated mesalamine remained relapse-free over six months of treatment than patients dosed with placebo. The granulated mesalamine formulation combines an enteric pH-dependent coating, which provides for delayed release, and a polymer matrix core, which provides for extended release. The company expects to release top-line results of the second Phase III trial and submit a new drug application later this year.
Also, Wilmington Pharmaceuticals, of Wilmington, N.C., granted Salix exclusive, worldwide rights to metoclopramide-Zydis, which is indicated for short-term therapy for adults with symptomatic documented gastroesphageal reflux who fail to respond to conventional therapy and for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. Wilmington Pharmaceuticals plans to file a new drug application for their Zydis formulation of metoclopramide in the fourth quarter of 2007. Salix is required to make a small up-front payment to Wilmington, a regulatory milestone payment upon NDA approval and to pay royalties to Wilmington on net sales. Additionally, Salix has entered into a separate agreement with Catalent Pharma Solutions, of Somerset, N.J., to supply the product. Catalent's Zydis technology is a freeze-dried oral solid dosage form that disintegrates rapidly on the tongue and can be taken without water.
Separately, Raleigh, N.C.-based Salix announced it has entered into a promotion deal with Eisai Inc. for Colazal (balsalazide disodium) Capsules 750 mg, and for balsalazide tablets 1100 mg, if and when approved by the FDA. About 600 members of Eisai's primary care and specialty sales forces will promote the products to select primary care physicians and gastroenterologists. Payment to Eisai will be based on a split of profit generated by prescriptions above a predetermined baseline. Salix does not expect to incur any incremental expenses with this agreement.
Shares of Salix (NASDAQ:SLXP) gained $1.64 Wednesday, or 14.5 percent, to close at $12.96.