Omeros Requests Fast Track Designation for OMS824 for the Treatment of Huntington's Disease

    Omeros Requests Fast Track Designation for OMS824 for the Treatment of
                             Huntington's Disease

-- Phase 2 Clinical Trial Slated to Begin This Year --

PR Newswire

SEATTLE, May 1, 2013

SEATTLE, May 1, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today
announced that it has requested Fast Track Designation from the U.S. Food and
Drug Administration (FDA) for the development of OMS824 for the treatment of
Huntington's disease. 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 is currently advancing OMS824 into a Phase 2 program.

FDA's Fast Track program facilitates the development of drugs intended to
treat serious or life-threatening conditions and that have the potential to
address unmet medical needs. Fast Track drugs are eligible for more frequent
and timely meetings with FDA to discuss the development plan and to ensure
that data needed for approval are collected appropriately. Drugs in the Fast
Track program typically are granted priority review status and their
respective New Drug Applications are accepted and reviewed by the FDA as
rolling submissions.

"Huntington's disease is devastating, and there is agreement among specialists
and affected families that the cognitive and behavioral symptoms of the
disease are the primary source of functional impairment," stated Gregory A.
Demopulos, M.D., chairman and chief executive officer of Omeros. "There
currently are no drugs that improve cognition in Huntington's patients nor are
there any disease-modifying therapies. OMS824 holds the potential to improve
both cognition and movement and to reduce the rate of neurodegeneration,
thereby slowing disease progression. If granted, Fast Track designation will
provide the opportunity to streamline clinical development of this promising
compound."

About Omeros' PDE10 Program
PDE10 is an enzyme that is expressed in areas of the brain linked to diseases
that affect cognition and psychomotor functions,  including Huntington's
disease and schizophrenia. Huntington's disease is a hereditary
neurodegenerative disorder that leads to movement, cognition, and behavioral
abnormalities and premature death. Cognitive dysfunction is responsible for
substantial disability in these diseases and is not improved by current
medications. Omeros' proprietary compound OMS824 inhibits PDE10 and is being
developed for the treatment of cognitive disorders. In addition to potential
benefits on cognition, OMS824 could also improve psychiatric manifestations,
such as the positive (e.g., hallucinations) and negative (e.g., flat affect)
symptoms of schizophrenia.

About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering,
developing and commercializing products targeting inflammation, coagulopathies
and disorders of the central nervous system. The Company's most clinically
advanced product candidates, OMS302 for lens replacement surgery and OMS103HP
for arthroscopy, are derived from its proprietary PharmacoSurgery‚ĄĘ platform
designed to improve clinical outcomes of patients undergoing a wide range of
surgical and medical procedures. Omeros has five clinical development
programs. Omeros may also have the near-term capability, through its GPCR
program, to add a large number of new drug targets and their corresponding
compounds to the market. Behind its clinical candidates and GPCR platform,
Omeros is building a diverse pipeline of protein and small-molecule
preclinical programs targeting inflammation, coagulopathies and central
nervous system disorders.

Forward-Looking Statements
This press release contains forward-looking statements as defined within the
Private Securities Litigation Reform Act of 1995, which are subject to the
"safe harbor" created by those sections. These statements include, but are not
limited to, Omeros' expectations that it will advance OMS824 into a Phase 2
clinical program; regarding the potential therapeutic benefits of OMS824; that
Fast Track designation would streamline the clinical development of OMS824;
and that Omeros may have capability, through its GPCR program, to add a large
number of new drug targets and their corresponding compounds to the market.
Forward-looking statements are based on management's beliefs and assumptions
and on information available to management only as of the date of this press
release. Omeros' actual results could differ materially from those anticipated
in these forward-looking statements for many reasons, including, without
limitation, the risks, uncertainties and other factors described under the
heading "Risk Factors" in the Company's Annual Report on Form 10-K filed with
the Securities and Exchange Commission on March 19, 2013. Given these risks,
uncertainties and other factors, you should not place undue reliance on these
forward-looking statements, and the Company assumes no obligation to update
these forward-looking statements publicly, even if new information becomes
available in the future.

SOURCE Omeros Corporation

Contact: Jennifer Cook Williams, Cook Williams Communications, Inc., Investor
and Media Relations, 360.668.3701, jennifer@cwcomm.org
 
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