UCERIS 2mg Rectal Foam For The Induction Of Remission Of Mild-To-Moderate Distal Ulcerative Colitis Granted Tentative Approval By FDA

Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) today announced that the FDA hasgranted tentative approval for UCERIS(R) (budesonide) rectal foam for theinduction of remission in patients with active mild-to-moderate distalulcerative colitis (UC) extending up to 40cm from the anal verge. The foamis a rectally administered corticosteroid that overcomes treatmentlimitations associated with currently approved therapies which are oftenineffective due to insufficient distribution of active drug to the distalcolon. The FDA's tentative approval of this product means that Salix's productmeets all of the FDA's manufacturing quality and clinical safety andefficacy standards and will be granted final approval upon the resolution ofpatent issues. Salix anticipates resolution of patent issues early in thefourth quarter of 2014 and the launch of UCERIS rectal foam during the firstquarter of 2015. "Distal ulcerative colitis can be challenging for patients to live with andgastroenterologists to treat. Our goal is to put the disease into remissionso that patients can get on with their lives," said Bill Forbes, ExecutiveVice President, Medical and Research and Development and Chief DevelopmentOfficer, Salix. "The unique delivery system of UCERIS rectal foam can helpovercome current treatment limitations by reaching the affected area of thedistal colon and keeping the medication there long enough to be effective.People suffering from distal UC now have another option to consider whenfacing this disease." Two identically designed, randomized, double-blind, placebo-controlled PhaseIII studies found that a significantly greater percentage of patientsreceiving UCERIS 2mg rectal foam achieved remission of distal ulcerativecolitis at six weeks compared with placebo (41.2% vs 24.0%). Significantlymore patients treated with UCERIS rectal foam also achieved key secondaryoutcome measures compared with placebo at six weeks, including a ModifiedMayo Disease Activity Index (MMDAI) endoscopy score of 0 or 1 in 55.6%versus 43.2% in the first trial and 56.0% vs 36.7% in the second trial. A significantly greater percentage of patients treated with UCERIS rectalfoam experienced improvement in rectal bleeding within the first two weeksof treatment (twice daily dosing); this percentage increased and wasmaintained after an additional two and four weeks of treatment once a day.At week six, the percentage of patients achieving MMDAI rectal bleedingscore of 0 was 46.6% vs 28.0% in the first trial and 50.0% vs 28.6% in thesecond trial. "These trials definitively demonstrated that UCERIS rectal foam is anefficacious and well-tolerated rectal therapy for the induction of remissionin patients with mild-to-moderate distal UC. Treatment with UCERIS rectalfoam also led to a rapid response for rectal bleeding that was sustainedthrough the sixth week of the trial," said William Sandborn, MD, Chief,Division of Gastroenterology and Director, UCSD IBD Center, University ofCalifornia San Diego and UC San Diego Health System, and principleinvestigator of the trials. "This unique treatment modality allows themedication to reach the target area and stay there long enough to work.UCERIS rectal foam is a welcome addition to the treatment options availableto gastroenterologists and their patients coping with this complex disease." UC is a chronic disease of the large intestine, also known as the colon, inwhich the lining of the colon becomes inflamed and develops tiny open sores,or ulcers, that produce pus and mucous. The combination of inflammation andulceration can cause abdominal discomfort and frequent emptying of thecolon. Distal ulcerative colitis is characterized as either ulcerativeproctitis (inflammation localized to the rectum) or ulcerativeproctosigmoiditis (inflammation localized to the distal colon and rectum). The Crohn's and Colitis Foundation of America (CCFA) estimates that UC mayaffect as many as 700,000 Americans. While most people are diagnosed intheir mid-30's, the disease can occur at any age and equally affects men andwomen. An estimated 46% of people with UC have a diagnosis of distal UC. About half of all patients with ulcerative colitis experience at least mildsymptoms including persistent diarrhea accompanied by abdominal pain andblood in the stool and more urgent bowel movements. CCFA also notes thatpeople suffering from UC often experience loss of appetite and may loseweight as a result. A feeling of low energy and fatigue is also common. Rectal therapy is recommended for the induction of remission in patientswith mild-to-moderate ulcerative proctitis, and recommended alone or incombination with oral aminosalicyclic acid (ASA) for mild-to-moderate distalUC. However, currently available rectal therapies have limitations,including difficulty of administration and retention (enemas) and limitedproximal spread (suppositories).