Specialty pharmaceutical companies Santarus (NASDAQ:SNTS) and Cosmo Pharmaceuticals (SIX:COPN) announced Thursday their positive results from the phase III clinical study of budesonide MMX for mild or moderate ulcerative colitis, a form of inflammatory bowel disease.
Ulcerative colitis produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements. It is believed that as many as 1.2 million people in the U.S. have IBD.
The disease is a chronic illness that relapses and then remits on and off again, and there is no known cure. However, up to 30% of patients with mild or moderate ulcerative colitis require add-on therapy to traditional treatment.
The phase III study, which was conducted in the U.S. and India to evaluate the safety and efficacy of the drug, showed that budesonide MMX, when taken once daily, met the primary endpoint by achieving clinical remission after eight weeks of treatment, as measured by the ulcerative colitis disease activity index. Using a dose of 9mg, 18% of patients taking the drug were in remission, versus slightly more than 7% in the placebo arm of the study.
The positive results are considered a step forward for the two companies toward the submission of a new drug application to the U.S. FDA. Results from the European phase III study are expected in November. Santarus and Cosmo Technologies, a subsidiary of Cosmo Pharmaceuticals, are collaborating on the phase III programs together.
"Assuming positive results in the European clinical study, we plan to submit the NDA in the second half of 2011 following the completion of an ongoing double-blind, placebo-controlled extended use study," said president and CEO of Santarus, Gerald T. Proehl.
The trial results also show that budesonide MMX was generally well tolerated, the company said.
The FDA has requested that the results from an additional 12-month extended use study be included in the Phase III clinical program to support a U.S. regulatory submission. The extended study of 123 patients taken from the phase III trials in the U.S., India and Europe will evaluate the long-term safety and tolerability of the drug, as well as collect data on its efficacy in maintaining the remission stage.
Budesonide MMX is a locally acting corticosteroid in an oral tablet formulation, which uses Cosmo's MMX multi-matrix system technology, designed for the controlled release and distribution of budesonide throughout the colon.
Italy-based Cosmo develops therapies for selected gastrointestinal and topically treated skin disorders. The company's pipeline specifically addresses treatments for IBD, such as ulcerative colitis and Crohn's disease, and colon infections.
Santarus is focused on acquiring, developing and commercializing products that address the needs of patients treated by specialists, including gastroenterologists, endocrinologists, allergists, immunologists and rheumatologists.
The company's current commercial efforts are focused on Glumetza and Cycloset, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes. It expects to commercially launch Cycloset in November 2010.
Santarus also has a pipeline that includes rifamycin SV MMX, for treatment of travelers' diarrhea and Rhucin, for treatment of acute attacks of hereditary angioedema.
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