Biopharmaceutical company Santarus, Inc. (SNTS) on Wednesday said the United States Food and Drug Administration has accepted for filing its new drug application for Uceris tablets indicated for treatment of inflammatory bowel disease.
With the application, or NDA, the company seeks approval to market Uceris (budesonide) tablets 9 mg in the U.S. as a therapy to induce remission of mild to moderate active ulcerative colitis. The company anticipates the completion of the FDA's review or a response to the NDA by mid-October 2012.
Santarus will now pay $4 million to the co-developer of the drug, Cosmo Technologies Limited, a unit of Japan's Cosmo Pharmaceuticals S.p.A, in cash or Santarus stock at Cosmo's option.
Ulcerative colitis is a form of inflammatory bowel disease that produces inflammation and ulcers along the inside of the colon that could cause cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements. According to the Crohn's & Colitis Foundation of America, the chronic relapsing-remitting illness affects an estimated 1.4 million Americans.
Gerald Proehl, president and chief executive officer, stated, "Ulcerative colitis is a serious, chronic disease that typically starts to manifest in young adults with a long-term negative impact on the patient. 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."
Santarus shares closed Tuesday's regular trading session at $4.80, down $0.12 or 2.44 percent.
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