Omeros Corporation Announces Approval of ICD-10 Codes for HSCT-TMA Diagnosis and for Narsoplimab Administration
May 04 2021 - 04:45AM
Business Wire
Omeros Corporation (Nasdaq: OMER) today announced that the
Centers for Disease Control and Prevention (CDC) has approved an
International Classification of Diseases (ICD-10) diagnosis code,
M31.11 – hematopoietic stem cell transplantation-associated
thrombotic microangiopathy (HSCT-TMA). The absence of a specific
HSCT-TMA diagnosis code has led to underreporting of diagnoses and
inaccurate coding, which has complicated reporting of the incidence
and outcomes of the disease. This new ICD-10 code, which will be
effective October 1, 2021, will for the first time allow
clinicians, payers and others to accurately track the incidence of
HSCT-TMA. Additional instructions about how to report the code will
be available from the CDC later this year.
Separately, the Centers for Medicare & Medicaid Services
(CMS) has approved two ICD-10-PCS codes for the administration of
narsoplimab: XW03357 – Introduction of Narsoplimab Monoclonal
Antibody into Peripheral Vein, and XW04357 – Introduction of
Narsoplimab Monoclonal Antibody into Central Vein, Percutaneous
Approach, New Technology Group 7. ICD-10-PCS codes are used by
billers to identify procedures and services performed during an
inpatient stay. These new procedure codes will also be effective
October 1, 2021. The new codes will be essential to facilitating
billing and reimbursement and for tracking utilization, if
narsoplimab is approved by the U.S. Food and Drug Administration
(FDA). Additional instructions about how to report the code will be
available from CMS later this year, and providers should consult
their payers for guidance on use of the codes.
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.
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 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.
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 or regulatory actions, 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 1, 2021, 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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Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations 360.668.3701 jennifer@cwcomm.org
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