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Omeros Files Orphan Drug Application for Treatment of Atypical Hemolytic Uremic Syndrome with OMS721
Date:4/17/2013

20-minute to two-hour intravenous infusion in a medical facility, while OMS721 is designed to be self-administered by subcutaneous injection, which would be more convenient for patients.

"We believe that OMS721 meets the criteria for orphan drug designation, representing a significant therapeutic advance over currently available treatments for aHUS," stated Gregory A. Demopulos , M.D., chairman and chief executive officer of Omeros. "We plan to file for the same designation in Europe, and we remain on track to begin clinical trials early this summer. The potential indications for OMS721 span a wide range of attractive markets in both orphan and highly prevalent diseases, and we are excited to evaluate its efficacy in patients."

About Orphan Drug Status

Orphan drug designation is granted by the FDA's Office of Orphan Products Development for treatments that are expected to provide significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients per year. Orphan drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983. The benefits apply across all stages of drug development and include accelerated approval process; seven years of market exclusivity following marketing approval; tax credits on U.S. clinical trials; eligibility for orphan drug grants; and waiver of certain administrative fees.

About Omeros' MASP-2 Program

Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system. The complement system plays a role in the inflammatory response and becomes activated as a result of tissue damage or microbial infection. MASP-2 appears to be unique to, and required for the function of, one of the principal complement acti
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