-- FDA sets PDUFA date of July 17, 2021 --
Omeros Corporation (Nasdaq: OMER) announced today that the
Biologics License Application (BLA) for narsoplimab for the
treatment of hematopoietic stem cell transplant-associated
thrombotic microangiopathy (HSCT-TMA) has been accepted for filing
by the U.S. Food and Drug Administration (FDA). The BLA has been
granted Priority Review with an FDA action date of July 17, 2021
under the Prescription Drug User Fee Act (PDUFA). FDA also
indicated in its filing letter that the Agency is not currently
planning to hold an advisory committee meeting to discuss the
BLA.
FDA grants Priority Review to applications for therapies that,
if approved, would be significant improvements in the safety or
effectiveness of the treatment, prevention or diagnosis of serious
conditions. Narsoplimab targets mannan-binding lectin-associated
serine protease-2 (MASP-2), the effector enzyme of the lectin
pathway of complement, and has received breakthrough therapy
designations and orphan drug designations from FDA for each of
HSCT-TMA and IgA nephropathy.
"The filing of our BLA by FDA marks an important milestone on
the path to commercialization of narsoplimab," stated Gregory A.
Demopulos, M.D., chairman and chief executive officer of Omeros.
"There is no FDA-approved product for the treatment of
transplant-associated TMA, a frequently fatal complication of stem
cell transplantation. We appreciate FDA’s collaborative approach
throughout the development of our breakthrough therapy-designated
product narsoplimab, and we are committed to continue working
closely with the FDA review team to make the drug available to
patients who need it."
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed
to discovering, developing and commercializing small-molecule and
protein therapeutics for large-market and orphan indications
targeting inflammation, complement-mediated diseases, disorders of
the central nervous system and immune-related diseases, including
cancers. Its commercial product OMIDRIA (phenylephrine and
ketorolac intraocular solution) 1%/0.3% continues to gain market
share in cataract surgery. Omeros’ lead MASP-2 inhibitor
narsoplimab targets the lectin pathway of complement and is the
subject of a rolling biologics license application under priority
review by FDA for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy. Narsoplimab is
also in multiple late-stage clinical development programs focused
on other complement-mediated disorders, including IgA nephropathy,
atypical hemolytic uremic syndrome and COVID-19. Omeros’ MASP-3
inhibitor OMS906, which targets the complement system’s alternative
pathway, recently entered the clinic, and the company’s PDE7
inhibitor OMS527 has successfully completed its Phase 1 trial.
Omeros’ pipeline holds a diverse group of preclinical programs
including a novel antibody-generating technology and a proprietary
GPCR platform through which it controls 54 new GPCR drug targets
and their corresponding compounds. One of these novel targets,
GPR174, modulates a new cancer immunity axis recently discovered by
Omeros, and the company is advancing small-molecule GPR174
inhibitors. For more information about Omeros and its programs,
visit www.omeros.com.
About Hematopoietic Stem Cell Transplant-associated
Thrombotic Microangiopathy
Hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA) is a significant and often lethal
complication of stem cell transplantation. This condition is a
systemic, multifactorial disorder caused by endothelial cell damage
induced by conditioning regimens, immunosuppressant therapies,
infection, graft-versus-host disease, and other factors associated
with stem cell transplantation. Endothelial damage, which activates
the lectin pathway of complement, plays a central role in the
development of HSCT-TMA. The condition occurs in both autologous
and allogeneic transplants but is more common in the allogeneic
population. In the United States and Europe, approximately 25,000
to 30,000 allogeneic transplants are performed annually. Recent
reports in both adult and pediatric allogeneic stem cell transplant
populations have found an approximately 40-percent incidence of
HSCT-TMA, and high-risk features may be present in up to 80 percent
of these patients. In severe cases of HSCT-TMA, mortality can
exceed 90 percent and, even in those who survive, long-term renal
sequalae (e.g., dialysis) are common. There is no approved therapy
or standard of care for HSCT-TMA.
About Narsoplimab
Narsoplimab, also known as “OMS721,” is an investigational human
monoclonal antibody targeting mannan-binding lectin-associated
serine protease-2 (MASP-2), a novel pro-inflammatory protein target
and the effector enzyme of the lectin pathway of complement.
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. Omeros controls the worldwide rights to MASP-2 and all
therapeutics targeting MASP-2.
A biologics license application (BLA) is under priority review
by the U.S. FDA for use of narsoplimab in the treatment of
hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA), and the drug is in Phase 3 clinical
programs for immunoglobulin A (IgA) nephropathy and atypical
hemolytic uremic syndrome (aHUS). The FDA has granted narsoplimab
breakthrough therapy designations for HSCT-TMA and for IgA
nephropathy; orphan drug status for the prevention (inhibition) of
complement-mediated thrombotic microangiopathies, for the treatment
of HSCT-TMA and for the treatment of IgA nephropathy; and fast
track designation for the treatment of patients with aHUS. The
European Medicines Agency has granted orphan drug designation to
narsoplimab for treatment in HSCT and for treatment of primary IgA
nephropathy. For additional information regarding narsoplimab and
its clinical trials, visit www.omeros.com/narsoplimab.
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,” “can,” “could,” “estimate,”
“expect,” “goal,” “intend,” “likely”, “look forward to,” “may,” “on
track,” “plan,” “potential,” “predict,” “project,” “prospects,”
“scheduled,” “should,” “slated,” “targeting,” “will,” “would” and
similar expressions and variations thereof. Forward-looking
statements, including statements regarding anticipated regulatory
submissions, the timing and results of ongoing or anticipated
clinical trials, and the therapeutic application of Omeros’
investigational product, 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, the impact of COVID-19 on our business, financial
condition and results of operations, regulatory oversight, changes
in reimbursement and payment policies by government and commercial
payers or the application of such policies, intellectual property
claims, competitive developments, litigation, and the risks,
uncertainties and other factors described under the heading “Risk
Factors” in the company’s Annual Report on Form 10-K filed with the
Securities and Exchange Commission (SEC) on March 2, 2020, as
supplemented by our Quarterly Reports on Form 10-Q filed with the
SEC and subsequent filings with the SEC. 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,
whether as a result of new information, future events or otherwise,
except as required by applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20210119005437/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations 360.668.3701 jennifer@cwcomm.org
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