SEATTLE, July 23, 2015 /PRNewswire/ -- Omeros
Corporation (NASDAQ: OMER) today announced that the U.S. Food and
Drug Administration (FDA) granted Fast Track designation to OMS721
for the treatment of patients with atypical hemolytic uremic
syndrome (aHUS). OMS721 is the company's lead human monoclonal
antibody targeting mannan-binding lectin-associated serine
protease-2 (MASP-2), the key regulator of the lectin pathway of the
immune system. Omeros is currently evaluating the drug in a Phase 2
clinical trial for the treatment of aHUS and other thrombotic
microangiopathies (TMAs). TMAs are a family of rare, debilitating
and life-threatening disorders characterized by excessive thrombi
(clots) in the microcirculation of the body's organs, most commonly
the kidney and brain. Earlier this year, Omeros announced positive
data from the Phase 2 trial and commencement of an
investigator-requested compassionate use program for OMS721 to
allow extended treatment of patients who completed the trial's
four-week dosing. Recent efficacy and safety data from the ongoing
Phase 2 clinical trial were submitted to the FDA in the company's
request for Fast Track status for OMS721.
FDA's Fast Track program facilitates the development of drugs
intended to treat serious or life-threatening conditions and that
have the potential to address unmet medical needs. A drug program
with Fast Track status is afforded greater access to the FDA for
the purpose of expediting the drug's development, review and
potential approval. Many drugs that receive Fast Track designation
are also considered appropriate to receive Priority Review, and
their respective New Drug Applications (NDAs) may be accepted by
the FDA as a "rolling submission" in which portions of an NDA are
reviewed before the complete application is submitted. Priority
Review and rolling submission can each provide further acceleration
of FDA's approval process.
"FDA's Fast Track designation of OMS721 for aHUS reflects the
unmet need associated with this disease and recognizes the drug's
potential as an important option for the treatment of aHUS," stated
Gregory A. Demopulos, M.D., chairman
and chief executive officer of Omeros. "We look forward to working
with the FDA to streamline the development of this promising drug,
and we currently remain on track to discuss with the Agency later
this year both the data from our Phase 2 trial in TMAs as well as
our plans for our Phase 3 program."
The Phase 2 clinical trial evaluating OMS721 in the treatment of
TMAs, including aHUS, thrombotic thrombocytopenic purpura and human
stem cell transplant-related TMAs, is ongoing in multiple sites in
both the United States and
Europe. The majority of the
patients enrolled to date are those suffering from aHUS.
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 appears to be unique to, and required
for the function of, one of the principal complement activation
pathways, known as the lectin pathway. 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 the 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. An ongoing Phase 2 clinical
program is evaluating OMS721 in the treatment of thrombotic
microangiopathies (TMAs), including atypical hemolytic uremic
syndrome, thrombotic thrombocytopenic purpura and stem cell
transplant-related TMAs. An investigator-requested compassionate
use program for OMS721 is also underway. Chronic toxicity studies
with systemically delivered OMS721 demonstrated no drug-related
adverse events, and Omeros plans to commercialize OMS721 for one or
more therapeutic indications as a subcutaneous injection.
Omeros also believes that it has identified the proteins that
activate 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
the development of antibodies that 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. Derived from its
proprietary PharmacoSurgery® platform, the company's
first drug product, Omidria® (phenylephrine and
ketorolac injection) 1%/0.3%, has been approved by the FDA 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. Omidria
received a positive opinion from the European Medicines Agency in
May and is currently under review for final marketing approval by
the European Commission. Omeros also recently partnered its
arthroscopic product, OMS103, for commercialization with Fagron
Sterile Services and affiliated JCB Laboratories, and sales are
expected to begin this year. Including the program for OMS721,
Omeros has five clinical-stage development programs focused on:
complement-related thrombotic microangiopathies; Huntington's
disease, schizophrenia, and cognitive impairment; and addictive and
compulsive disorders. In addition, Omeros has a proprietary GPCR
platform, which is making available an unprecedented number of new
GPCR drug targets and corresponding compounds to the pharmaceutical
industry for drug development.
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. 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 Omeros'
ability to obtain regulatory approval for its Marketing
Authorization Application in the EU for the commercialization of
Omidria®, sales of OMS103, Omeros' unproven preclinical
and clinical development activities, regulatory oversight, product
commercialization, 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 11, 2015.
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.
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SOURCE Omeros Corporation