SEATTLE--(BUSINESS WIRE)--Feb. 20, 2019--
Omeros Corporation (Nasdaq: OMER) today announced that, as the company
prepares for planned commercialization of OMS721, the United States
Adopted Names (USAN) Council, in consultation with the World Health
Organization’s International Nonproprietary Names (INN) Expert
Committee, has selected for the drug the nonproprietary name
“narsoplimab.” Narsoplimab is the company’s lead human monoclonal
antibody targeting mannan-binding lectin-associated serine protease-2
(MASP-2), the effector enzyme of the lectin pathway of the complement
system, and is currently being evaluated in three Phase 3 clinical
programs: hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA), immunoglobulin A (IgA) nephropathy and
atypical hemolytic uremic syndrome. Narsoplimab holds breakthrough
therapy designations from the U.S. Food and Drug Administration (FDA)
for the treatment of high-risk HSCT-TMA and for the treatment of IgA
nephropathy and, to the company’s knowledge, no other drug has
breakthrough therapy designation for either of these indications.
Narsoplimab is proprietary to Omeros with issued patents running to 2032
and currently pending patents that are expected to extend coverage until
2037.
The USAN Council, by working closely with the INN Programme of the World
Health Organization and various national nomenclature groups, aims for
global standardization and unification of drug nomenclature to ensure
that drug information is communicated accurately and unambiguously.
Going forward, Omeros will use the name “narsoplimab” in upcoming
publications and public statements, at conferences and other forums, and
in commercialization-related materials as the company continues
progressing toward commercialization of the product in HSCT-TMA and
other indications. The company is working with an international branding
agency to finalize a global proprietary brand name for narsoplimab.
Omeros is initially targeting approval for narsoplimab in HSCT-TMA, and
the company has initiated preparation of its biologics license
application (BLA) and marketing authorization application (MAA) for
submission to FDA and to the European Medicines Agency, respectively.
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 referred to 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 IgA
nephropathy and for HSCT-TMA, orphan drug status for the prevention
(inhibition) of complement-mediated thrombotic microangiopathies, for
the treatment of IgA nephropathy, for the treatment of HSCT-TMA, and
fast track designation for the treatment of patients with aHUS. The
European Medicines Agency has granted orphan drug designation to
narsoplimab for treatment of primary IgA nephropathy and for treatment
in HSCT.
Omeros also has identified MASP-3 as responsible for the conversion of
pro-factor D to factor D and as a critical activator of the human
complement system’s alternative pathway. 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 has initiated the
manufacturing scale-up process of its MASP-3 antibodies in preparation
for clinical trials.
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 and disorders of the central
nervous system. 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, the ability for OMIDRIA to obtain
separate reimbursement as part of CMS’ OPPS, 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 8, 2018. 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: https://www.businesswire.com/news/home/20190220005465/en/
Source: Omeros Corporation
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor
and Media Relations
360.668.3701
[email protected]
