SEATTLE, Sept. 3, 2015 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has filed patent infringement lawsuits against Par Pharmaceutical, Inc. and its subsidiary, Par Sterile Products, LLC, (collectively "Par") in the U.S. District Court for the District of New Jersey and in the U.S. District Court for the District of Delaware. The lawsuits were filed under the Hatch-Waxman Act for Par's infringement of three Omeros patents, U.S. Patent Nos. 8,173,707, 8,586,633 and 9,066,856, which relate to Omeros' drug Omidria® (phenylephrine and ketorolac injection) 1%/0.3% and which are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book, published by the U.S. Food and Drug Administration ("FDA"). The lawsuits were filed in response to a Paragraph IV certification notice Omeros received from Par, dated July 23, 2015, regarding Par's filing with the FDA of an Abbreviated New Drug Application ("ANDA") seeking approval to market a generic version of Omidria prior to the expiration of the three Orange Book-listed patents for Omidria. These patents were granted following review by the U.S. Patent and Trademark Office, are presumed to be valid under governing law, and can only be invalidated in federal court with clear and convincing evidence.
Under the Hatch-Waxman Act, Omeros was permitted to file suit within 45 days from its receipt of Par's notice and thereby trigger a 30-month stay of the FDA's approval of Par's ANDA. The stay is expected to remain in effect until March 2018. Omeros has reviewed Par's Paragraph IV assertions and believes they do not have merit. Omeros has sought access to Par's ANDA, which Par is legally required to provide under reasonable terms, but to date Par has not provided this access. Omeros will obtain access to Par's ANDA and will vigorously prosecute its infringement claims against Par.
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.
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.
SOURCE Omeros Corporation