– Preparations Continue for Submission of BLA in the U.S. and
MAA in Europe –
SEATTLE–(BUSINESS WIRE)–Omeros Corporation (Nasdaq: OMER) today announced that the European
Medicines Agency (EMA) has appointed rapporteurs for the company’s
marketing authorization application (MAA) currently in preparation for
narsoplimab for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy (HSCT-TMA).
Narsoplimab, also known as “OMS721,” is Omeros’ lead human monoclonal
antibody targeting mannan-binding lectin-associated serine protease-2
(MASP-2) and is in Phase 3 clinical programs for the treatment of
HSCT-TMA, immunoglobulin A nephropathy, and atypical hemolytic uremic
syndrome.
The appointed rapporteurs are members of EMA’s Committee for Human
Medicinal Products (CHMP) and will jointly coordinate CHMP’s evaluation
of Omeros’ planned MAA for narsoplimab. Omeros intends to request a
pre-submission meeting with the rapporteurs to discuss the planned
submission of the MAA. As previously announced, narsoplimab for HSCT-TMA
is eligible for submission under EMA’s centralized review procedure,
which allows submission of a single MAA that, if approved, authorizes
the product to be marketed in all 31 member states comprising the
European Economic Area rather than requiring separate national
approvals. Narsoplimab also has orphan drug designation from EMA for
treatment in hematopoietic stem cell transplantation. Omeros is
preparing both a U.S. biologics license application (BLA) and a European
MAA for narsoplimab for the treatment of HSCT-TMA.
About Omeros’ MASP Programs
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 is the effector enzyme of the lectin
pathway, one of the principal complement activation pathways.
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
circulation. Gene-targeted MASP-2-deficient mice and humans with MASP-2
gene polymorphisms that affect MASP-2 serum levels and MASP-2 functional
activity are generally healthy with no obvious adverse phenotype.
Phase 3 clinical programs are in progress for narsoplimab, Omeros’ lead
MASP-2 inhibitor also known as “OMS721,” in hematopoietic stem cell
transplant-associated thrombotic microangiopathy (HSCT-TMA), in
immunoglobulin A (IgA) nephropathy, and in atypical hemolytic uremic
syndrome (aHUS). Narsoplimab can be administered both intravenously and
subcutaneously, and Omeros expects to commercialize each formulation of
narsoplimab for different therapeutic indications. In
parallel, Omeros is developing small-molecule inhibitors of MASP-2.
Based on requests from treating physicians, Omeros has established a
compassionate-use program for narsoplimab, which is active in both the
U.S. and Europe. The FDA has granted narsoplimab breakthrough therapy
designation for HSCT-TMA and IgA nephropathy; orphan drug status for the
prevention (inhibition) of complement-mediated thrombotic
microangiopathies, for the treatment of HSCT-TMA and for the treatment
of IgA nephropathy; and fast track designation for the treatment of
patients with aHUS. The European Medicines Agency has granted orphan
drug designation to narsoplimab for treatment in HSCT and for treatment
of primary IgA nephropathy.
Omeros also has identified MASP-3 as the key activator of the human
complement system’s alternative pathway and as the enzyme responsible
for the conversion of pro-factor D to factor D. The alternative pathway
is linked to a wide range of immune-related disorders. In addition to
its lectin pathway inhibitors, the company is advancing its development
of antibodies and small-molecule inhibitors against MASP-3 to block
activation of the alternative pathway. Omeros is scaling up the
manufacturing of its MASP-3 antibodies in preparation for clinical
trials slated for next year. In addition to its MASP-2- and
MASP-3-specific programs, Omeros is developing bi-specific inhibitors of
MASP-2/MASP-3.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed to
discovering, developing and commercializing small-molecule and protein
therapeutics for large-market as well as orphan indications targeting
inflammation, complement-mediated diseases, disorders of the central
nervous system and immune-related diseases, including cancers. The
company’s drug product OMIDRIA (phenylephrine and ketorolac intraocular
solution) 1% / 0.3% is marketed 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, the European Commission has approved
OMIDRIA for use in cataract surgery and other IOL replacement procedures
to maintain mydriasis (pupil dilation), prevent miosis (pupil
constriction), and to reduce postoperative eye pain. Omeros has multiple
Phase 3 and Phase 2 clinical-stage development programs focused on:
complement-associated thrombotic microangiopathies; complement-mediated
glomerulonephropathies; cognitive impairment; and addictive and
compulsive disorders. In addition, Omeros has a diverse group of
preclinical programs and a proprietary G protein-coupled receptor (GPCR)
platform through which it controls 54 new GPCR drug targets and
corresponding compounds, a number of which are in preclinical
development. The company also exclusively possesses a novel
antibody-generating platform.
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,” “likely”, “look forward
to,” “may,” “plan,” “potential,” “predict,” “project,” “prospects,”
“should,” “slated,” “targeting,” “will,” “would” and similar expressions
and variations thereof. 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 and
commercial operations, 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 Annual Report on Form 10-K filed with the Securities and
Exchange Commission on March 1, 2019. 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.
Contacts
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org