The approach of new steroid options for ulcerative colitis

Salix gains tentative approval on Uceris foam [link]

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This content is from our UpdatesPlus-IBD service.  To access our September issue, offering 79 slides of monitoring and analysis of key research and development advances over the past weeks in inflammatory bowel disease please contact us - We cover Ulcerative Colitis and Crohn disease, biologics, orals and topicals, and also supportive care for anemia.  

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• As mentioned in the September issue of UpdatesPlus-IBD, the PDUFA date for Uceris (budesonide) rectal foam for ulcerative colitis was yesterday

• Salix has now announced that the FDA has granted tentative approval

• The oral formulation of Uceris was launched Feb 2013 and most recent quarterly sales were $42.5M

• The oral formulation allows treatment of distal disease as it is formulated in a gastro-resistant tablet which forms a hydrogel in the colon, providing extended release of budesonide in a time-dependent manner.

• The rectal foam is also designed for improved access, allowing exposure extending up to 40cm from the anal verge.   Retention is greater than with current enema formulations and distribution improved compared to suppositories.  Efficacy was reported from 2 pivotal studies in 2013

• The tentative approval reflects outstanding patent issues. which Salix anticipates will be resolved by Q4 2014 allowing Q1 2015 launch

Comments:  The outstanding patent issues relate to AstraZeneca's patent covering Entocort enteric coated budesonide capsules.  Salix does not believe Uceris Foam infringes AstraZeneca's patent however AstraZeneca has a 45-day period for filing suit.  Once this period has expired the FDA will then be able to approve Uceris foam