-- OMS721 Requested for Finnish Patient Not
Adequately Responsive to Soliris® --
SEATTLE--(BUSINESS WIRE)--Feb. 24, 2016--
Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed
to discovering, developing and commercializing both small-molecule and
protein therapeutics for large-market as well as orphan indications
targeting inflammation, coagulopathies and disorders of the central
nervous system, today announced further expansion of its OMS721
compassionate use program to Finland. OMS721 is Omeros’ lead human
monoclonal antibody in its mannan-binding lectin-associated serine
protease-2 (MASP-2) program for the treatment of thrombotic
microangiopathies (TMAs), including atypical hemolytic uremic syndrome
(aHUS).
Based on review of OMS721 data, Finnish physicians requested access to
OMS721 under a Special License, granted by the Finnish regulatory
authorities, to treat a patient with aHUS. The patient was previously
treated with Soliris® (eculizumab) but was determined to not
have an adequate response, continuing to display signs of active aHUS.
The patient is expected to begin treatment with OMS721 next month.
In other recent compassionate use, OMS721 was provided to a young
patient on long-term dialysis. Because of her active aHUS, she was not
healthy enough for kidney transplantation. Following treatment with
OMS721, her clinical status stabilized and the investigator has
determined that her aHUS is no longer an impediment to kidney
transplantation. Omeros is working with her physicians to assure
availability of OMS721 throughout her transplantation and
postoperatively.
“Omeros is committed to continue working with physicians to enable
patients with aHUS and other TMAs to receive OMS721,” stated Gregory A.
Demopulos, M.D., chairman and chief executive officer of Omeros. “We are
helping patients who, for whatever reason, have not adequately responded
to or cannot access Soliris and need a different option to treat these
devastating diseases. It is gratifying to see that, following OMS721
treatment, the dialysis-dependent patient is considered eligible for
kidney transplantation, and we look forward to helping the Finnish
patient for whom Soliris was ineffective. As physician requests
increase, we continue to expand our compassionate use program, making
OMS721 available to patients who need it.”
About Omeros’ MASP 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 is associated with a wide range of autoimmune
disorders. 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. Omeros has received both orphan drug status and fast
track designation from the U.S. FDA for its lead human MASP-2 antibody
OMS721. Omeros is advancing to a Phase 3 clinical program evaluating
OMS721 in the treatment of atypical hemolytic uremic syndrome and is
continuing its Phase 2 program targeting thrombotic thrombocytopenic
purpura and stem cell transplant-related thrombotic microangiopathies.
In addition, an OMS721 Phase 2 program has been initiated in
complement-related renal diseases. An investigator-requested
compassionate use program for OMS721 is also underway. OMS721 has
demonstrated no safety concerns in human trials or chronic toxicity
studies. In addition to potential intravenous administration, Omeros
plans to commercialize OMS721 for one or more therapeutic indications as
a subcutaneous injection.
Omeros also believes that it has identified the proteins that activate
the complement system’s alternative pathway in humans, which is linked
to a wide range of immune-related disorders. In addition to its lectin
pathway inhibitors, the company’s OMS906 program is advancing the
development of antibodies targeting MASP-3 that block activation of the
alternative pathway.
About Omeros Corporation
Omeros is a biopharmaceutical company committed to discovering,
developing and commercializing both small-molecule and protein
therapeutics for large-market as well as orphan indications targeting
inflammation, coagulopathies and disorders of the central nervous
system. Derived from its proprietary PharmacoSurgery® platform,
the company’s first drug product, Omidria® (phenylephrine and
ketorolac injection) 1%/0.3%, has been approved by the FDA for use
during cataract surgery or intraocular lens (IOL) replacement to
maintain pupil size by preventing intraoperative miosis (pupil
constriction) and to reduce postoperative ocular pain. In the European
Union, European Commission has approved Omidria for use in cataract
surgery and lens replacement procedures to maintain mydriasis (pupil
dilation), prevent miosis (pupil constriction), and to reduce
postoperative eye pain. Omeros has five clinical-stage development
programs focused on: complement-related thrombotic microangiopathies;
complement-mediated glomerulopathies; Huntington’s disease and cognitive
impairment; addictive and compulsive disorders; and preventing problems
associated with urologic surgical procedures. In addition, Omeros has a
proprietary GPCR platform, which is making available an unprecedented
number of new GPCR drug targets and corresponding compounds to the
pharmaceutical industry for drug development.
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of
the Securities Exchange Act of 1934, which are subject to the “safe
harbor” created by those sections for such statements. All statements
other than statements of historical fact are forward-looking statements,
which are often indicated by terms such as “anticipate,” “believe,”
“could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,”
“may,” “plan,” “potential,” “predict,” “project,” “should,” “will,”
“would” and similar expressions. 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, risks associated with product commercialization including
with respect to Omidria® and OMS103, Omeros’ ability to
partner and commercialize Omidria in Europe, Omeros’ unproven
preclinical and clinical development activities, regulatory oversight,
intellectual property claims, competitive developments, litigation, and
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, 2015. 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, even if new
information becomes available in the future.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160224005617/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org