The US Food and Drug Administration (FDA) has accepted for filing the Santarus Inc.'s New Drug Application (NDA) for Uceris (budesonide) tablets 9 mg. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Santarus expects the FDA will complete its review or otherwise respond to the Uceris NDA by mid-October. Santarus is seeking marketing approval in the US of Uceris 9 mg for the induction of remission of mild to moderate active ulcerative colitis.

“Ulcerative colitis is a serious, chronic disease that typically starts to manifest in young adults with a long-term negative impact on the patient,” said Gerald T Proehl, president and chief executive officer. “We look forward to the potential to offer what we believe will be an important new therapeutic option to physicians and their patients to manage the symptoms of active ulcerative colitis.”

Uceris is an investigational drug that is a locally acting (non-systemic) corticosteroid in a novel, patented, oral tablet formulation, which utilizes proprietary MMX multi-matrix system technology and 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. With FDA acceptance for review of the NDA for Uceris tablets, $4 million is payable to Cosmo Technologies in cash or Santarus common stock, at Cosmo's option.

The NDA for Uceris was filed as a section 505(b)(2) NDA, referencing data generated for Entocort EC (budesonide). In connection with the FDA's acceptance for filing of the Uceris NDA, Santarus is providing notice to the NDA holder and the patent owner that Uceris 9 mg does not infringe any claims of the one unexpired patent listed in the Orange Book for Entocort EC or that the claims in the patent are invalid.

Ulcerative colitis is a form of inflammatory bowel disease (IBD) that 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, diarrhoea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life. According to the Crohn's & Colitis Foundation of America, IBD affects an estimated 1.4 million Americans.

Ulcerative colitis is a chronic relapsing-remitting illness for which there is no known cure, but with appropriate treatment patients can manage their symptoms. However, it is estimated that up to 30 per cent of patients with mild or moderate ulcerative colitis require add-on therapy to 5-ASA drugs. Patients refractive to treatment with 5-ASA drugs typically receive a course of an oral, systemically absorbed corticosteroid, the success of which may be limited by significant side effects. For moderate to severe cases of ulcerative colitis, immunosuppressant drugs or biologic drugs may be prescribed. If the condition does not respond to pharmaceutical therapy and the symptoms are severe, the patient may be referred for surgery.

Santarus, Inc. is focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists.