-- Sales maintain the drug’s European marketing authorization --
SEATTLE--(BUSINESS WIRE)--Jul. 23, 2018--
Omeros Corporation (NASDAQ: OMER) today announced initial sales of
OMIDRIA® (phenylephrine and ketorolac intraocular solution)
1%/0.3% in Europe. OMIDRIA, approved and commercially available in the
U.S., is also approved in the European Union (EU) for use in cataract
and lens replacement surgery to maintain mydriasis (pupil dilation),
prevent miosis (pupil constriction), and to reduce postoperative eye
pain. These sales satisfy the “sunset clause” provision in the EU and
maintain the ongoing validity of the European marketing authorization
for OMIDRIA, allowing Omeros continued flexibility in its partnering,
sales and pricing strategies for OMIDRIA throughout Europe.
The “sunset clause” requires a medicinal product to be placed on the
market in at least one European country within three years of the
European Commission granting the product marketing authorization;
otherwise, that authorization is no longer valid. Following successful
completion of required testing, labeling, packaging and release for its
European use, OMIDRIA has been made available on a limited basis in the
EU, satisfying the clause and preserving the company’s options for
European commercialization while Omeros continues building utilization
and value for OMIDRIA in the U.S.
Pass-through status and separate payment for OMIDRIA by the Centers for
Medicare and Medicaid Services are scheduled to re-initiate in the U.S.
on October 1.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed to
discovering, developing and commercializing small-molecule and protein
therapeutics for large-market as well as orphan indications targeting
inflammation, complement-mediated diseases and disorders of the central
nervous system. The company’s drug product OMIDRIA®
(phenylephrine and ketorolac intraocular solution) 1% / 0.3% is marketed
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. In the European
Union, the European Commission has approved OMIDRIA for use in cataract
surgery and other IOL replacement procedures to maintain mydriasis
(pupil dilation), prevent miosis (pupil constriction), and to reduce
postoperative eye pain. Omeros has multiple Phase 3 and Phase 2
clinical-stage development programs focused on: complement-associated
thrombotic microangiopathies; complement-mediated
glomerulonephropathies; cognitive impairment; and addictive and
compulsive disorders. In addition, Omeros has a diverse group of
preclinical programs and a proprietary G protein-coupled receptor (GPCR)
platform through which it controls 54 new GPCR drug targets and
corresponding compounds, a number of which are in preclinical
development. The company also exclusively possesses a novel
antibody-generating platform.
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,” “will,” “would” and similar expressions and variations
thereof. 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
product commercialization and commercial operations, unproven
preclinical and clinical development activities, regulatory oversight,
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 10, 2018. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180723005203/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org
