-- Discussions Ongoing with European Regulators for Pathway to
Expedited Approval --
SEATTLE--(BUSINESS WIRE)--Jul. 25, 2018--
Omeros Corporation (Nasdaq: OMER) announced today that the European
Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products
(COMP) issued a positive opinion recommending orphan drug designation of
OMS721 for treatment in hematopoietic stem cell transplantation. OMS721
is Omeros’ 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. Three OMS721 Phase 3 clinical
programs are progressing across hematopoietic stem cell
transplant-associated thrombotic microangiopathy (TMA), immunoglobulin A
(IgA) nephropathy, and atypical hemolytic uremic syndrome (aHUS).
The positive opinion is expected to be published by COMP within the week
and to be adopted by the European Commission in August. Orphan Drug
Designation in Europe is available to companies developing
products intended to treat a life-threatening or chronically
debilitating condition that affects fewer than five in 10,000 persons in
the European Union (EU). This designation allows for financial and
regulatory incentives that include 10 years of marketing exclusivity in
the EU after product approval, reduced EMA advisory, inspection and
filing fees pre- and post-approval, and guaranteed access to centralized
marketing authorization valid in all EU member states as well as in the
European Economic Area countries (i.e., Iceland, Liechtenstein and
Norway).
The U.S. Food and Drug Administration (FDA) earlier granted orphan
designation to OMS721 for the prevention (inhibition) of
complement-mediated TMA and, in April of this year, granted breakthrough
therapy designation to OMS721 for the treatment of stem cell-transplant
patients who have persistent TMA despite modification of
immunosuppressive therapy. Discussions are ongoing with both U.S. and
European regulators regarding expedited pathways to approval for OMS721
in the treatment of “high-risk” stem cell transplant-associated 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. 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. OMS721 is Omeros’ lead human MASP-2 antibody.
Phase 3 clinical programs are in progress for OMS721 in atypical
hemolytic uremic syndrome (aHUS), in immunoglobulin A (IgA) nephropathy
and in hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA). Also, two Phase 2 trials are ongoing. One is
continuing to enroll IgA nephropathy patients and has already generated
positive data in patients with IgA nephropathy and with lupus nephritis;
the other is enrolling and has reported positive data in patients with
HSCT-TMA and in patients with aHUS. OMS721 can be administered both
intravenously and subcutaneously, and Omeros expects to commercialize
each formulation of OMS721 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 OMS721, which is active in both the U.S.
and Europe. The FDA has granted OMS721 breakthrough therapy designation
for IgA nephropathy and for high-risk HSCT-TMA, orphan drug status for
the prevention (inhibition) of complement-mediated thrombotic
microangiopathies and for the treatment of IgA nephropathy, and fast
track designation for the treatment of patients with aHUS.
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,” “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 Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission on May 10, 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/20180725005339/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams,
360-668-3701
Investor and Media Relations
jennifer@cwcomm.org
