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FDA Grants Orphan Drug Designation to Bayer's Investigational Compound Regorafenib for the Treatment of Gastrointestinal Stromal Tumors
Date:2/4/2011

A) provides for the orphan drug designation which aims to encourage the development of drugs involved in the diagnosis, prevention or treatment of a medical condition affecting fewer than 200,000 people in the country. The designation grants U.S. market exclusivity to a drug for a particular indication for a seven-year period if the sponsor complies with certain FDA specifications. Additional incentives for the sponsor include tax credits related to clinical trial expenses and a possible exemption from the FDA-user fee. The designation does not shorten the duration of the regulatory review and approval process.  

About GIST

GIST is the most common form of sarcoma involving the gastrointestinal tract. GISTs arise in the GI tract, with most primary tumors originating in the stomach or small intestine. GIST represents a potentially life-threatening malignancy if the disease has spread to other parts of the body (metastasized) or is unable to be surgically removed with curative intent. The incidence of GIST is estimated to be 11 to 20 patients per million per year. The international prevalence of GISTs is comparable to that reported in the United States. In the U.S., it is estimated that there are approximately 4,500-6,000 new cases of GISTs diagnosed each year, of which about 1,500 have already metastasized when they are initially found. GISTs are difficult to diagnose and are usually found incidentally when the doctor is looking for other problems.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions.  As a specialty pharmaceutical company, Bayer HealthCare Pharmaceutical
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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