Santarus gets thumbs-up from FDA for Uceris colonic delivery

The FDA has approved Santarus' ($SNTS) Uceris, an extended release formulation that delivers the steroid budesonide to the gut, for the treatment of active, mild to moderate ulcerative colitis.

Uceris uses the MMX multimatrix colonic delivery system, which delivers the drug to the gut gradually over time. Originally developed by Cosmo Technologies, the MMX system coats the active drug with pH-resistant acrylic copolymers. These polymers dissolve when they reach the right pH and so can be tailored to release the drug exactly where it is needed. Santarus signed an agreement with Cosmo in 2008, gaining exclusive U.S. rights to Uceris and rifamycin SV MMX, and the latter product is in a Phase III trial for the treatment of travelers' diarrhea.

Santarus plans to launch Uceris in March, and has taken the opportunity to boost its sales team by 85 to support Uceris and other products for gastroenterology, diabetes and metabolic disease. The approval of Uceris has triggered the payment of about $4 million in success-based regulatory milestone expenses.

The inflammatory bowel disease ulcerative colitis is distressing and painful, and in its active phase it interferes with work and daily life and can even lead to hospitalization.

"The FDA approval of Uceris provides an important new therapeutic option to patients and physicians for the treatment of active, mild to moderate ulcerative colitis," said William Sandborn of the University of California-San Diego.

- read the press release