Omeros Announces Toxicology Study Data from MASP-2 Inhibitor

         Omeros Announces Toxicology Study Data from MASP-2 Inhibitor

-- IND/CTA Submission Expected in the Second Quarter of 2013 --

PR Newswire

SEATTLE, Feb. 7, 2013

SEATTLE, Feb. 7, 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. Based on the data from these nonhuman primate
studies, OMS721 is expected to be delivered subcutaneously to patients at a
convenient dosing schedule of weekly, bi-monthly or even less frequently.
Omeros is now analyzing additional data and expects to submit, in the second
quarter of this year, an Investigational New Drug (IND) Application or
Clinical Trial Application (CTA) to the applicable regulatory body to initiate
clinical trials evaluating OMS721.

MASP-2 is 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. 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 hemolytic uremic syndrome (HUS), atypical HUS
(aHUS), paroxysmal nocturnal hemoglobinuria (PNH), wet age-related macular
degeneration (AMD), ischemia-reperfusion injury, transplant-related
complications and other immune-related disorders.

The studies reported today demonstrated that, following subcutaneous
administration, the plasma concentration of OMS721 rapidly approached a
plateau, which correlated with maximal inhibition of lectin pathway
activation, within six hours of administration and maintained that level of
inhibition for two or more weeks. In addition, the observed bioavailability
and pharmacokinetics 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 continue to advance OMS721 through IND-enabling studies, we are pleased
to see that our complement inhibitor is revealing its potential competitive
advantages, including subcutaneous administration and maintenance of activity
of the acquired immune response to infection," stated Gregory A. Demopulos,
M.D., chairman and chief executive officer of Omeros. "These and the other
data that we are collecting bode well for the commercial potential of OMS721.
We expect to file our IND or CTA next quarter and look forward to moving the
drug product quickly into clinical trials."

About Omeros' MASP-2 Program
MASP-2 is 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 file an IND or CTA and
begin clinical trials of OMS721; that OMS721 may be delivered subcutaneously
and the frequency of dosing; the potential 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 Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on November 9, 2012. 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, +1-360-668-3701, jennifer@cwcomm.org
 
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