SEATTLE, June 16, 2015 /PRNewswire/ -- Omeros
Corporation (NASDAQ: OMER), a biopharmaceutical company committed
to discovering, developing and commercializing small-molecule and
protein therapeutics for both large-market as well as orphan
indications, today announced that it has entered into an exclusive
license agreement with affiliates of Fagron NV (EBR: FAGR) for the
commercialization of OMS103, Omeros' product for arthroscopic
surgery.
OMS103, added to standard irrigation solution used in
arthroscopy, is Omeros' proprietary PharmacoSurgery®
product designed to provide a multimodal approach to block
preemptively the inflammatory cascade induced by arthroscopic
surgical procedures. Nearly five million arthroscopic procedures
are projected to be performed in the U.S. in 2015.
Under the terms of the license agreement, Omeros granted Fagron
an exclusive license to the OMS103 intellectual property,
manufacturing information, and clinical data in the United States. In exchange for the U.S.
license, Fagron will pay Omeros a substantial majority share of the
gross revenues generated from sales of OMS103 with Omeros also
receiving a minimum revenue per vial sold. In addition, Fagron will
pay Omeros up to an aggregate total of $10
million in commercial milestones, some of which will be
received by Omeros as revenue-share enhancement on early sales.
Fagron is obligated to meet performance diligence requirements
including the commencement of sales of OMS103 in 2015, to bear all
sales and marketing costs, and to meet annual sales volume
minimums. In addition to transferring the manufacturing and
clinical information related to OMS103, Omeros is obligated to
provide Fagron with introductions to arthroscopy thought leaders
and assistance in understanding the therapeutic field as well as
administration methods and to provide Fagron for 12 months with
reasonable access to Omeros personnel to respond to any queries
regarding the clinical and manufacturing data. Omeros will incur no
further development costs, other than maintaining the licensed
intellectual property, in connection with OMS103. The licensing
agreement also contemplates potential partnerships for additional
products from Omeros' PharmacoSurgery platform.
"Early postoperative pain is predominantly inflammatory pain,
and clinical evaluation of OMS103 demonstrated better pain
reduction together with less narcotic usage and less frequent
incidence of postoperative inflammatory problems," stated
William E. Garrett, Jr., M.D., Ph.D,
professor of orthopaedic surgery and team physician at Duke University. "There is increasing evidence that
intraoperative joint inflammation is detrimental to the long-term
health of the joint, and control of postoperative pain and
inflammation is critical to functional recovery in arthroscopy
patients. Delivered intraoperatively, OMS103 provides an
opportunity to inhibit inflammation and related problems before
they begin and could become a key component in managing arthroscopy
patients."
"We selected Fagron as our U.S. partner for OMS103 because of
its robust sterile GMP manufacturing and commercial capabilities,"
stated Gregory A. Demopulos, M.D.,
chairman and chief executive officer of Omeros. "We believe that
Fagron has the reach and expertise to bring OMS103 to orthopedic
surgeons and their patients nationwide."
In addition to its current U.S. sterile manufacturing
capabilities, Fagron is scheduled to open later this year one of
the country's largest FDA-registered 503B human drug outsourcing
facilities, which is expected to utilize automation not yet seen in
the nation's sterile compounding industry. Together with Fagron's
current operations, this state-of-the-art outsourcing facility is
planned for use to produce commercial supplies of OMS103.
About Omeros' OMS103 Program
OMS103 is a proprietary combination of
anti-inflammatory/analgesic active pharmaceutical ingredients
(APIs), specifically amitriptyline, ketoprofen and oxymetazoline,
each with well-known safety and pharmacologic profiles. One of the
major challenges facing orthopedic surgeons performing arthroscopic
procedures is adequately controlling the local inflammatory
response to surgical trauma, particularly the inflammatory pain and
swelling that are associated with detrimental effects on the
long-term health of the joint. Added to standard irrigation
solutions, OMS103 is delivered directly to the joint throughout
arthroscopy, and is designed to act simultaneously at multiple
distinct targets to block preemptively the inflammatory cascade
induced by arthroscopic surgery.
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. The marketing
authorization application (MAA) for Omidria recently received a
unanimous positive opinion from the European Medicines Agency,
which forwarded the MAA to the European Commission for decision
regarding final approval. Omeros has five clinical-stage
development programs focused on: complement-related thrombotic
microangiopathies; Huntington's disease, schizophrenia, and
cognitive impairment; addictive and compulsive disorders; and
preventing problems associated with surgical procedures. 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 beliefs and
assumptions of Omeros' management 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' collaboration
with JCB contained in this press release, Omeros' ability to obtain
regulatory approval for its Marketing Authorization Application in
the EU for the commercialization of Omidria®, 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 Omeros' 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