-- With Voluntary Dismissal of Infringement Suit Against Sandoz,
Omeros Wraps Up All Pending ANDA Litigation --
SEATTLE--(BUSINESS WIRE)--Jul. 26, 2018--
Omeros Corporation (Nasdaq: OMER) today announced that its patent
infringement lawsuit against Sandoz Inc. (Sandoz) concerning Sandoz’s
Abbreviated New Drug Application (ANDA), which sought approval from the
U.S. Food and Drug Administration (FDA) to market a generic version of
Omeros’ cataract surgery drug OMIDRIA® (phenylephrine and
ketorolac intraocular solution) 1% / 0.3%, has been dismissed by
stipulation of the parties. Omeros agreed to the dismissal because
Sandoz amended its ANDA to no longer seek FDA approval to market its
proposed generic drug prior to the expiration of all of Omeros’ Orange
Book-listed patents for OMIDRIA. The latest expiry date of these patents
is July 2033.
Omeros commercially launched OMIDRIA, the only FDA-approved product of
its kind, in 2015. Two years later, in the setting of steadily
increasing OMIDRIA sales, Omeros received a Paragraph IV certification
from Sandoz in connection with Sandoz’s ANDA filing for a generic
version of OMIDRIA. Omeros responded with patent infringement litigation
against Sandoz. Sandoz has now converted to a Paragraph III
certification, which means that FDA cannot approve the ANDA until after
the July 2033 expiry of all patents listed in the Orange Book for
OMIDRIA, namely U.S. Patent No. 8,173,707, U.S. Patent No. 8,586,633,
U.S. Patent No. 9,066,856, U.S. Patent No. 9,278,101, U.S. Patent No.
9,399,040, U.S. Patent No. 9,486,406, and U.S. Patent No. 9,855,246.
With Sandoz’ conversion to a Paragraph III certification and Omeros’
agreement to dismiss its patent infringement litigation against Sandoz,
all of Omeros’ pending litigation with ANDA filers has been concluded.
Omeros previously announced that it had settled lawsuits against two
other ANDA filers – Par Sterile Products, LLC and Par Pharmaceutical,
Inc. (Par) and Lupin Ltd. and its subsidiary Lupin Pharmaceuticals, Inc.
(Lupin). Based on these settlement agreements, the earliest ANDA entry
date for any of the three generic manufacturers is April 2032 unless
otherwise subsequently authorized pursuant to the settlement agreements.
“We are pleased that Par, Lupin and now Sandoz have decided to respect
our OMIDRIA patents,” stated Gregory A. Demopulos M.D., chairman and
chief executive officer of Omeros. “With the favorable resolution of all
three generic challenges, Omeros now is planning for nearly 14 years of
market exclusivity for OMIDRIA. We look forward to the October 1
re-initiation of CMS’ pass-through status and separate payment for
OMIDRIA so that, once again, we can ensure broad access to the drug’s
benefits for ophthalmic surgeons and their cataract surgery patients.”
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/20180726005283/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org
