-- Omeros Continues to Expand Orphan Indications for OMS721 --
SEATTLE--(BUSINESS WIRE)--Nov. 3, 2016--
Omeros Corporation (NASDAQ: OMER) today announced that it has filed an
application for orphan drug designation with the U.S. Food and Drug
Administration (FDA) for OMS721 in the treatment of immunoglobulin A
(IgA) nephropathy (also known as Berger’s disease). IgA nephropathy
leads to end-stage renal disease in up to 40 percent of patients. Orphan
drug designation is granted to treatments that target conditions
affecting 200,000 or fewer U.S. patients per year. Orphan-designated
drugs are eligible for financial incentives and regulatory advantages
such as a faster approval process and additional market exclusivity.
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.
FDA earlier granted orphan designation for OMS721 in thrombotic
microangiopathies (TMAs), including atypical hemolytic uremic syndrome
(aHUS) and hematopoietic stem cell-associated TMA (HSCT-TMA). Based on
positive Phase 2 data in renal diseases, Omeros also recently filed for
FDA fast track designation for OMS721 in IgA nephropathy. The company
already has received fast track designation for OMS721 in aHUS.
In addition to positive Phase 2 data in IgA and membranous
nephropathies, Omeros has reported positive data from Phase 2 clinical
trials in both aHUS and HSCT-TMA. Following guidance from FDA and from
the European Medicines Agency, Omeros plans to open enrollment for its
single Phase 3 trial in patients with aHUS later this year. Based on
discussions with the FDA, the company is pursuing breakthrough therapy
designation for OMS721 in IgA nephropathy and in HSCT-TMA, neither of
which has any approved treatment. Omeros plans to initiate OMS721 Phase
3 programs in both IgA nephropathy and HSCT-TMA next year.
About Orphan Drug Status
Orphan drug designation is granted
by the FDA’s Office of Orphan Products Development for treatments that
are expected to provide significant therapeutic advantage over existing
treatments and that target conditions affecting 200,000 or fewer U.S.
patients per year. Orphan drug designation qualifies a company for
several benefits under the Orphan Drug Act of 1983. The benefits apply
across all stages of drug development and include accelerated approval
process; seven years of market exclusivity following marketing approval;
tax credits on U.S. clinical trials; eligibility for orphan drug grants;
and waiver of certain administrative fees.
About Omeros’ MASP-2 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 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. Omeros has received both
Orphan Drug status and fast track designation from the U.S. FDA for its
lead human MASP-2 antibody OMS721. Following discussions with both the
FDA and the European Medicines Agency, a Phase 3 program for OMS721 in
atypical hemolytic uremic syndrome is in progress. Also, two Phase 2
trials are ongoing with one evaluating OMS721 in glomerulonephropathies,
which has generated positive data in patients with immunoglobulin A
(IgA) nephropathy and with membranous nephropathy, and the other in
thrombotic microangiopathies (TMAs), with positive data reported in
patients with hematopoietic stem cell transplant-associated TMA. In
addition to potential intravenous administration, Omeros plans to
commercialize OMS721 for one or more therapeutic indications as a
subcutaneous injection and is also 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.
Omeros also has identified MASP-3 as the protein that is critical to the
activation of 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 is advancing its
development of antibodies and small-molecule inhibitors against MASP-3
to 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. Part of its proprietary PharmacoSurgery®
platform, the company’s first drug product, OMIDRIA®
(phenylephrine and ketorolac injection) 1%/0.3%, was broadly launched in
the U.S. in April 2015. OMIDRIA is the first and only FDA-approved drug
(1) 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 and (2)
that contains an NSAID for intraocular use. In the European Union, the
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 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
proprietary G protein-coupled receptor (GPCR) platform, which is making
available an unprecedented number of new GPCR drug targets and
corresponding compounds to the pharmaceutical industry for drug
development, and a platform used to generate antibodies.
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 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, 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 August 9, 2016. 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/20161103005580/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org
