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Raptor Pharmaceuticals Corp. Receives FDA Orphan Drug Designation for Cysteamine in Huntington's Disease
Date:6/9/2008

00 persons or less in the U.S. Orphan drug designation by the FDA allows for seven years of market exclusivity following approval of a New Drug Application, as well as reduced regulatory fees and additional regulatory support for research and development initiatives.

Ted Daley, president of Bennu, stated, "Huntington's Disease is a terrible, debilitating disorder with no current cure. Available drugs can only minimize symptoms, such as uncontrollable movements and mood swings. The FDA's decision to grant cysteamine orphan drug designation in Huntington's Disease complements our efforts to develop additional indications for cysteamine. We will be building off of the existing preclinical data that shows cysteamine's safety and potential efficacy to treat HD. We look forward to initiating a Phase II clinical study in HD patients in 2008."

Dr. Christopher M. Starr, Raptor's Chief Executive Officer, stated, "We are delighted that the FDA has granted orphan drug designation for cysteamine in HD. Our team at Raptor is well-versed in developing and gaining regulatory approval of new therapies for orphan drug disorders. We hope to contribute some of this orphan drug expertise and know-how to facilitate Bennu's clinical program for HD."

Through its acquisition by merger of Encode Pharmaceuticals in December 2007, Bennu obtained an exclusive, worldwide license to the intellectual property rights for the development of cysteamine from UC San Diego for the treatment of certain diseases including cystinosis, non-alcoholic steatohepatitis ("NASH") and Huntington's disease.

About Raptor Pharmaceuticals Corp.

Raptor Pharmaceuticals Corp.'s business consists of two segments: its 100% ownership of development stage biotechnology company Raptor Pharmaceutical Inc. ("Raptor Inc."); and its 100% ownership of clinical-stage development company Bennu. Raptor Inc. bioengineers novel drug candidates and drug- targeting platforms derived from the human recep
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SOURCE Raptor Pharmaceuticals Corp.
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