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Investigational New Drug Application Cleared by FDA for OMS824 in Huntington's Disease
Date:5/23/2013

SEATTLE, May 23, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that its Investigational New Drug Application (IND) to evaluate OMS824 in Huntington's disease has been cleared by the U.S. Food and Drug Administration (FDA). OMS824 selectively inhibits phosphodiesterase 10 (PDE10), an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia. OMS824 has shown promising results in animal models directly relevant to Huntington's disease and, as previously announced, OMS824 was well tolerated and exhibited favorable pharmacokinetic properties in a Phase 1 clinical program. Omeros plans to advance OMS824 into Phase 2 clinical trials for Huntington's disease next quarter and for schizophrenia later this year, the OMS824 IND for use in patients with schizophrenia having already been cleared by the FDA.

Omeros also announced today that it has requested Orphan Drug Designation from the FDA for OMS824 in the treatment of Huntington's disease. Orphan-designated drugs are eligible for incentives such as a faster approval process and additional market exclusivity. This designation is granted to drugs that are expected to provide significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients annually. Huntington's disease is estimated to affect approximately 31,000 U.S. patients annually, and the only FDA‑approved treatment for the disease is tetrabenazine, which is indicated for Huntington's-related movement disorders. Omeros recently announced that it has requested Fast Track designation for OMS824 in the treatment for Huntington's disease. Fast Track designation is reserved for drugs being developed to treat life-threatening conditions with the potential to address unmet medica
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SOURCE Omeros Corporation
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