Phrixus Pharmaceuticals Announces Orphan Drug Designation


Carmeseal™ was granted orphan-drug designation by the FDA in January 2010

ANN ARBOR, Mich. (January 2010)
Thomas A. Collet, Chief Executive Officer of Phrixus,
stated, “The Orphan Drug designation is important as we move forward in our development of

Orphan drug designation is granted by the FDA to novel drugs that treat rare diseases or
conditions affecting fewer than 200,000 patients in the U.S. The designation provides the drug
developer, in this case Phrixus, with a seven-year period of U.S. marketing exclusivity if the
drug is the first of its type approved for the specified indication or if it demonstrates superior
safety, efficacy, or a major contribution to patient care versus another drug of its type previously
granted the designation for the same indication, as well as with tax credits for clinical research
costs, the ability to apply for annual grant funding, clinical research trial design assistance and
waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

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