-- Initiates International Market Expansion --
SEATTLE--(BUSINESS WIRE)--May 10, 2016--
Omeros Corporation (NASDAQ: OMER), 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, today announced entry into an exclusive supply and
distribution agreement for the sale of OMIDRIA (phenylephrine and
ketorolac injection) 1% / 0.3% in the Kingdom of Saudi Arabia, the
United Arab Emirates and other countries in the Middle East with ITROM
Trading Drug Store (ITROM). ITROM is Dubai-based and an internationally
recognized pharmaceutical marketing and distribution company
specializing in ophthalmology. Under the agreement, ITROM will be
responsible for obtaining marketing authorizations for OMIDRIA within
the licensed territory and for marketing, selling and distributing
product supplied by Omeros. Existing ophthalmology medical sales
representatives employed by ITROM are expected to be reinforced with
additional medical sales representatives that will be dedicated to
OMIDRIA.
“We expect that ITROM will begin sales of OMIDRIA later this year,” said
Gregory A. Demopulos, M.D., chairman and chief executive officer of
Omeros. “This marks the start of our expansion to international markets,
and we look forward to bringing the benefits of OMIDRIA to patients
outside of the U.S.”
“ITROM and our affiliate companies have been successfully representing
innovative and breakthrough products within our region for several years
now,” stated ITROM Pharmaceutical Group’s Managing Director Dr. Ismail
Soboh. “We believe that Omidria definitely falls in this
highly-sought-after category of products.”
About OMIDRIA®
Omeros’ OMIDRIA® (phenylephrine and ketorolac injection) 1% /
0.3% is the only FDA-approved product for use during cataract surgery or
intraocular lens replacement to maintain pupil size by preventing
intraoperative miosis (pupil constriction) and to reduce postoperative
ocular pain. OMIDRIA also is the only NSAID-containing product
FDA-approved for intraocular use. In post-launch studies across
conventional and femtosecond laser-assisted cataract surgery, OMIDRIA
has been shown (1) to be effective in patients with intraoperative
floppy iris syndrome (IFIS), pseudoexfoliation and other ophthalmic
conditions, (2) to significantly reduce complication rates, use of
pupil-expanding devices and surgical times, and (3) to significantly
improve uncorrected visual acuity on the first day following cataract
surgery. While OMIDRIA is broadly indicated for use in cataract surgery
in adults, the above outcomes are not in its currently approved
labeling. Surgical time was not an endpoint in the OMIDRIA Phase 3
clinical trials and did not reach statistical significance in post hoc
analysis of the Phase 3 data.
Important Risk Information for OMIDRIA®
Systemic exposure of phenylephrine may cause elevations in blood
pressure. In clinical trials, the most common reported ocular adverse
reactions at two to 24 percent are eye irritation, posterior capsule
opacification, increased intraocular pressure, and anterior chamber
inflammation; incidence of adverse events was similar between
placebo-treated and OMIDRIA-treated patients. OMIDRIA must be added to
irrigation solution prior to intraocular use. OMIDRIA is not approved
for use in children.
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%, was broadly launched in the U.S. in April
2015 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 lens replacement procedures to maintain
mydriasis (pupil dilation), prevent miosis (pupil constriction), and to
reduce postoperative eye pain. Omeros has five clinical-stage
development programs focused on: complement-related thrombotic
microangiopathies; complement-mediated glomerulopathies; Huntington’s
disease and cognitive impairment; addictive and compulsive disorders;
and preventing problems associated with urologic 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, and a platform used to generate antibodies.
About ITROM Trading Drug Store / Pharma Consult
ITROM Trading Drug Store (ITDS) / Pharma Consult is a
comprehensive & firmly rooted pharmaceutical establishment with its
headquarters based in Dubai, U.A.E., solely committed to representing,
registering, marketing, and distributing pharmaceutical products
throughout the MENA region (Middle East & North Africa), while
regionally maintaining a 55 members strong team of Medical Sales
Representatives on its own payroll. ITDS’ dedicated focus is
Ophthalmological applications, where it has pioneered introducing
Hyaluronic acid eye drops in the area over the past decade, while
tailoring its ongoing portfolio to patented and innovative
pharmaceutical products. ITDS currently represents and manages active
regional businesses for 8 international companies, with a diverse
portfolio comprising a total of 15 innovative & private label products.
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 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 including with respect to OMIDRIA®, Omeros’
ability to partner and commercialize OMIDRIA in the Middle East and
Europe, ITROM’s ability to add field representatives and commence sales
of OMIDRIA later this year, Omeros’ unproven preclinical and clinical
development activities, regulatory oversight, intellectual property
claims, competitive developments, litigation including pending patent
litigation related to an application seeking approval from the FDA to
market a generic version of OMIDRIA, 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, 2016. 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: http://www.businesswire.com/news/home/20160510005734/en/
Source: Omeros Corporation
for Omeros:
Cook Williams Communications, Inc.
Jennifer
Cook Williams, 360-668-3701
Investor and Media Relations
jennifer@cwcomm.org