SEATTLE, Aug. 17, 2015 /PRNewswire/ -- Omeros
Corporation (NASDAQ: OMER) today, in response to investor
questions, announced that it plans to file a patent infringement
lawsuit against Par Pharmaceutical, Inc. and its subsidiary, Par
Sterile Products, LLC (Par) in response to the Abbreviated New Drug
Application (ANDA) filed by Par seeking FDA approval to market a
generic version of Omeros' commercial drug Omidria®
(phenylephrine and ketorolac injection) 1%/0.3%. Omidria is
approved by the U.S. Food and Drug Administration (FDA) 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. As reported in the
company's Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on August 10,
2015, Omeros received a notice from Par on July 27, 2015, which addresses the ANDA and Par's
request to market a generic version of Omidria pursuant to
Paragraph IV of the Hatch-Waxman Act following expiration of the
drug's New Product Exclusivity and, if applicable, the subsequent
Pediatric Exclusivity, but prior to the expiration of three patents
published in the FDA's Approved Drug Products with Therapeutic
Equivalence Evaluations, or Orange Book, which have terms extending
to as late as 2033. Approximately 3.8 million cataract and lens
replacement procedures are projected in the U.S. in 2015.
Omeros currently owns 34 issued patents worldwide related to
Omidria. The patents that are listed in the Orange Book were
granted by multiple examiners in multiple art groups based on
review of prior art from multiple searches. Omeros is highly
confident in its patent estate protecting Omidria.
Omeros has reviewed Par's Paragraph IV assertions and plans to
file a patent infringement suit against Par within 45 days of
Omeros' receipt of Par's notice. In this regard, Omeros has engaged
a prominent Hatch-Waxman litigation team at Covington & Burling
LLP. Filing of the planned lawsuit will trigger what is generally a
30-month stay of FDA action on Par's ANDA. Issued U.S. patents are
presumed to be valid, and only clear and convincing evidence
presented in federal court can establish invalidity.
Independent of its patents, Omidria has also received
36-month market exclusivity through the New Product Exclusivity
provided by the Federal Food, Drug, and Cosmetic Act as well as an
additional six months of market exclusivity available upon
successful completion of the company's pediatric clinical plan
according to the Written Request from FDA.
"Generic manufacturers challenging branded drug products is
'business as usual' in the pharmaceutical industry and, based on
its track record this is not an uncommon activity for Par," stated
Gregory A. Demopulos M.D., chairman
and chief executive officer of Omeros. "This action confirms our
belief in the market potential of Omidria. We are confident in the
strength of our product's broad patent estate. We have engaged one
of the premier biotech patent litigation teams in the country to
pursue aggressively our case against Par, so I do not anticipate
this effort becoming a distraction for Omeros. We remain focused on
continuing to build on our successful launch of Omidria and on
increasing the product's market uptake."
About Omidria®
Omeros'
PharmacoSurgery® product Omidria® contains
the mydriatic (pupil-dilating) agent phenylephrine and the
anti-inflammatory agent ketorolac and was developed for use during
cataract or other IOL replacement surgery. The FDA has approved
Omidria for use during cataract surgery or IOL replacement to
maintain pupil size by preventing intraoperative miosis (pupil
constriction) and to reduce postoperative ocular pain.
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%, 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. In the
European Union, 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 partnered its
arthroscopic product, OMS103, for commercialization with Fagron
Sterile Services and affiliated JCB Laboratories. Omeros has five
clinical-stage development programs focused on: complement-related
thrombotic microangiopathies; Huntington's disease, schizophrenia,
and cognitive impairment; and addictive and compulsive disorders.
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 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, product commercialization including
with respect to Omidria® and OMS103, risks associated
with Omeros' ability to partner and commercialize Omidria in
Europe, Omeros' 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 August 10,
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