Omeros Announces Toxicology Data that Support Advancing MASP-2 Inhibitor into Clinical Trials

Omeros Announces Toxicology Data that Support Advancing MASP-2 Inhibitor into
                               Clinical Trials

-- European Clinical Trial Application Submission Expected in the Second
Quarter of 2013 --

PR Newswire

SEATTLE, March 28, 2013

SEATTLE, March 28, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER)
today announced data from toxicology studies evaluating OMS721, the lead human
monoclonal antibody in Omeros' mannan-binding lectin-associated serine
protease-2 (MASP-2) program. In non-human primates and rodents, there were no
drug-related findings in the toxicology assessments, including gross
pathology, histopathology (still ongoing in the rodent), clinical signs and
clinical chemistries. Omeros expects to submit a European Clinical Trial
Application (CTA) in the second quarter of this year to initiate clinical
trials evaluating OMS721.

Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting
MASP-2, a novel pro-inflammatory protein involved in activation of the
complement system – an important component of the immune system. The
complement system plays a role in the inflammatory response to tissue damage
or microbial infection. OMS721 selectively inhibits MASP-2, blocking the
lectin pathway of the complement system while leaving intact the classical
pathway, or the acquired immune response to infection. The Company has
conducted a series of in vivo studies that suggest that MASP-2 inhibition may
have a preventive or therapeutic effect in the treatment of atypical hemolytic
uremic syndrome (aHUS), HUS, wet age-related macular degeneration (AMD),
paroxysmal nocturnal hemoglobinuria (PNH), transplant-related complications,
ischemia-reperfusion injury, and other immune-related disorders.

The studies reported today in both primates and rodents provide the primary
safety data expected to support the initiation of OMS721 clinical studies in
mid-year 2013. The pharmacokinetic results in primates demonstrated that
subcutaneous administration of OMS721 resulted in maximal inhibition of the
lectin pathway within six hours of administration and maintained it for two or
more weeks. In addition, the bioavailability and pharmacokinetics observed in
both species are expected to support subcutaneous administration in patients
at a frequency of once weekly, bi-monthly or possibly at even longer
intervals. The only currently approved complement inhibitor requires an
intravenous infusion lasting 30 minutes or longer in the hospital or doctor's
office. Subcutaneous dosing avoids the complexity and inconvenience of
intravenous infusion and would allow patients to self-administer OMS721 at
home.

"As we wrap up our CTA-enabling studies, OMS721 continues to impress with its
potential competitive advantages, including subcutaneous administration,
convenient dosing, and maintenance of the acquired immune response to
infection," stated Gregory A. Demopulos, M.D., chairman and chief executive
officer of Omeros. "OMS721 holds significant promise to treat a wide range of
immune-related disorders, and today's data further underscore the commercial
opportunities for OMS721. We plan to focus initially on aHUS, a rare and
life-threatening indication seen most commonly in children. Submission of our
CTA is expected next quarter, and we look forward to evaluating the drug
product soon in clinical trials."

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 activation pathways, known as the lectin pathway. Importantly,
inhibition of MASP-2 does not appear to interfere with the antibody-dependent
classical complement activation pathway, which is a critical component of the
acquired immune response to infection, and its abnormal function is associated
with a wide range of autoimmune disorders. MASP-2 is generated by the liver
and is then released into the circulation. Adult humans who are genetically
deficient in one of the proteins that activate MASP-2 do not appear to be
detrimentally affected by the deficiency. Therefore, Omeros believes that it
may be possible to deliver MASP-2 antibodies systemically.

Omeros also believes that it has identified the proteins that activate the
complement system's alternative pathway, which is linked to a wide range of
immune-related disorders. In addition to its lectin pathway inhibitors, the
Company is advancing the development of antibodies that would block activation
of the alternative pathway alone or in combination with the lectin pathway.

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™ 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 regarding when it will submit a CTA for
OMS721 and begin clinical trials; that OMS721 may be delivered subcutaneously
and the frequency of dosing; the diseases that may be treated by OMS721; the
potential competitive advantages of OMS721; 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 18, 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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