-- EMA also reviewing Priority Medicines application for the drug in
IgAN --
SEATTLE--(BUSINESS WIRE)--Jan. 22, 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 on Omeros’ application for orphan drug
designation of OMS721 in the treatment of primary Immunoglobulin A
nephropathy (IgAN). 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, and
is in Phase 3 development for each of IgAN, atypical hemolytic uremic
syndrome (aHUS), and hematopoietic stem cell transplant-associated
thrombotic microangiopathy (TMA).
The positive opinion issued by COMP is expected to be adopted by the
European Commission at its February meeting. 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 a 10-year period of marketing exclusivity in the EU after
product approval, protocol assistance from the EMA at reduced
fees during the product development phase, and access to centralized
marketing authorization.
In August of 2017, the U.S. Food and Drug Administration (FDA) granted
orphan designation to OMS721 for the treatment of IgAN and, in June of
2017, FDA granted breakthrough therapy designation to OMS721 for
IgAN. Omeros has requested from EMA Priority Medicines (PRIME) status
for OMS721 in the treatment of IgAN.
“We are pleased with EMA’s positive opinion and look forward to
receiving confirmation next month of orphan drug designation in the EU
for OMS721 in IgA nephropathy,” said Gregory A. Demopulos, M.D.,
chairman and chief executive officer of Omeros. “Already having received
orphan and breakthrough drug designations in the US, we are now awaiting
EMA’s decisions on PRIME status for OMS721 in IgA as well as in stem
cell transplant-associated TMA, and we will be submitting our
breakthrough drug application to FDA for OMS721 in stem cell-TMA within
the next few weeks. Enrollment in our Phase 3 trial in IgA
nephropathy is expected to open in February and we also are on track to
initiate our Phase 3 trial in stem cell-TMA in the first half of this
year after discussion with regulatory authorities.”
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 (HCT-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
HCT-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, 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; Huntington’s disease and
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,” “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 November 9, 2017. 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/20180122005753/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org
