Santarus Announces FDA Extension of UCERIS New Drug Application Target Action Date to January 16, 2013
(NASDAQ: SNTS) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the review of the New Drug Application (NDA) for UCERIS (budesonide) tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis from October 16, 2012 to January 16, 2013. The three-month extension is a standard extension period.
On August 3, 2012, following the FDA’s request, Santarus submitted additional information for the Office of Scientific Investigations, which is the division of the FDA responsible for ensuring compliance with Good Clinical Practices (GCP), in connection with U.S. and ex-U.S. pre-approval inspections. On August 10, 2012, the company received a communication from the FDA that the submission has been classified as a major amendment to the NDA. Since the submission was received within three months of the target action date, the FDA is extending the PDUFA date by three months to provide time for a full review of the submitted information.
The FDA also indicated that if major deficiencies are not identified during the review of the NDA, the FDA plans to communicate proposed labeling and, if necessary, any postmarketing requirement/commitment requests to Santarus by December 12, 2012. Assuming FDA approval, Santarus anticipates that it will be in a position to commence the launch of UCERIS approximately two months following the determination of the final product label.
UCERIS is an investigational drug that is a locally acting, non-systemic corticosteroid in a novel, patented, oral tablet formulation that utilizes proprietary MMX multi-matrix system technology, which is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide has topical anti-inflammatory activity and due to an extended first pass effect, has less systemic absorption than other corticosteroids. UCERIS is being developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A.
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company’s current commercial efforts are focused on (metformin hydrochloride extended release tablets) and (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes, and on (fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol.
Santarus has a diverse product development pipeline. A New Drug Application for UCERIS (budesonide) tablets for induction of remission of mild to moderate active ulcerative colitis is under review by the U.S. Food and Drug Administration with a response expected in January 2013. The pipeline also includes two late-stage investigational drugs in Phase III clinical studies: RUCONEST (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema and rifamycin SV MMX for treatment of travelers’ diarrhea. In addition, the company’s investigational monoclonal antibody, SAN-300, is being evaluated in a Phase I clinical program. More information about Santarus is available at .