myTomorrows, a global health technology company, and Omeros
Corporation (Nasdaq: OMER), an innovative biopharmaceutical company
committed to discovering, developing and commercializing
small-molecule and protein therapeutics, today announced a
collaboration. The collaboration broadens Omeros’ expanded access
program to support availability of Omeros’ novel investigational
complement inhibitor narsoplimab in several countries around the
world. Narsoplimab is being developed by Omeros as a treatment for
hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA) and may be provided to eligible patients
who have no other treatment options and when prescribed on a Named
Patient basis.
“Through our Medical Team, we engage with physicians looking for
treatment options for their patients with high unmet needs and who
cannot access an existing clinical trial,” said Steve Glass, COO of
myTomorrows. “Our collaboration with Omeros is an important step in
growing our expanded access programs and providing physicians
information on potential treatment options.”
“We are pleased to partner with myTomorrows to broaden our
expanded access program,” said Gregory A. Demopulos, M.D., chairman
and chief executive officer of Omeros. “We are excited by the
results seen with narsoplimab in patients with HSCT-TMA, and this
partnership with myTomorrows advances our mission to help patients
with this devastating condition by continuing to provide them
access to narsoplimab.”
Narsoplimab has been granted Breakthrough Therapy designation by
the US Food and Drug Administration (FDA) in patients with
high-risk HSCT-TMA and has orphan drug designation in both the US
and Europe. Omeros has initiated submission of a rolling biologics
license application (BLA) to the FDA to be followed by a marketing
authorization application for HSCT-TMA in Europe. In preparation
for completing its BLA submission, Omeros recently stopped
enrollment of its pivotal clinical trial of narsoplimab for the
treatment of HSCT-TMA.
About Expanded Access Programs
An Expanded Access Program (sometimes called “compassionate
use”) supports in a compliant and controlled way the treatment with
a medicine currently not licensed in a patient’s country of
residence. Such treatment can be an option for patients who have
high unmet medical need and have exhausted all registered treatment
options and cannot participate in a clinical trial.
About HSCT-TMA
Hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA) is a significant and often lethal
complication of stem cell transplants. This condition is a
systemic, multifactorial disorder caused by endothelial cell damage
induced by conditioning regimens, immunosuppressant therapies,
infection, GvHD, 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 HSCT-TMA incidence of approximately 40 percent, 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
are common. There is no approved therapy or standard of care for
HSCT-TMA.
About myTomorrows
myTomorrows operates as a two-sided platform. It serves the
interests of both patients and healthcare providers, as well as
drug development. On one side, the company provides information on
all treatment options to patients and physicians when registered
treatments have been exhausted. Requests may come in to myTomorrows
by phone, email, or through an online portal. After which
physicians and patients will be directed to a member of our Medical
Team for more information regarding treatment options. And on the
other side, myTomorrows specializes in expanded access regulations
and administration and real-world data collection, evolving
scientific clinical development. myTomorrows has gained experience
in running over 25 EAPs over the past 5 years, in more than 40
countries across 5 continents. For more information, please visit
www.mytomorrows.com.
About Omeros Corporation
Omeros is an innovative biopharmaceutical company committed to
discovering, developing and commercializing small-molecule and
protein therapeutics for large-market as well as orphan indications
targeting complement-mediated diseases, disorders of the central
nervous system and immune-related diseases, including cancers. In
addition to its commercial product OMIDRIA® (phenylephrine and
ketorolac intraocular solution) 1%/0.3%, Omeros has multiple Phase
3 and Phase 2 clinical-stage development programs focused on
complement-mediated disorders and substance abuse, as well as a
diverse group of preclinical programs including GPR174, a novel
target in immuno-oncology that modulates a new cancer immunity axis
recently discovered by Omeros. Small-molecule inhibitors of GPR174
are part of Omeros’ proprietary G protein-coupled receptor (GPCR)
platform through which it controls 54 new GPCR drug targets and
their corresponding compounds. The company also exclusively
possesses a novel antibody-generating platform.
For specific questions regarding the Omeros’ expanded access
program, please contact myTomorrows at
omeros.medical@mytomorrows.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,” “could,” “estimate,” “expect,”
“goal,” “intend,” “likely”, “look forward to,” “may,” “plan,”
“potential,” “predict,” “project,” “prospects,” “should,” “slated,”
“targeting,” “will,” “would” and similar expressions and variations
thereof. Forward-looking statements, including statements regarding
Omeros’ research and development programs and the therapeutic
application of Omeros’ research findings, 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, unproven preclinical and clinical development
activities, availability and timing of data from preclinical or
clinical studies and the results of such studies, risks associated
with product commercialization and commercial operations,
regulatory actions and oversight, 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 on March 1, 2019. 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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version on businesswire.com: https://www.businesswire.com/news/home/20191218005245/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations 360.668.3701 jennifer@cwcomm.org
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