Press Release

View printer-friendly version << Back

Sandoz Amends ANDA to Not Seek Approval for Generic Version of OMIDRIA Until Patents for Omeros’ Drug Expire

-- 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.

Source: Omeros Corporation

Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor and Media Relations