Wired News – Omeros Settles Lawsuit Against Lupin for Filing ANDA With FDA for Marketing Generic Version of OMIDRIA(R)
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LONDON, UK / ACCESSWIRE / May 29, 2018 / If you want access to our free research report on Omeros Corp. (NASDAQ: OMER), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=OMER as the Company's latest news hit the wire. On May 24, 2018, the Company announced that it has reached a settlement agreement with Lupin Ltd and its subsidiary Lupin Pharmaceuticals, Inc. ("Lupin") to resolve the patent infringement lawsuit filed against Lupin. Omeros had filed the case against Lupin as it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for approval to market a generic version of Omeros' commercial drug OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3%. The financial terms of the settlement were not disclosed by the Company. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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OMIDRIA® is a phenylephrine and ketorolac injection which is used during cataract surgery and intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain.
Commenting on the settlement agreement with Lupin for OMIDRIA®, Gregory A. Demopulos M.D., Chairman and CEO of Omeros, said:
"We are pleased with the Lupin settlement agreement. With both the Par and Lupin litigation now settled, we remain focused on the near-term objectives for OMIDRIA® – preparing for resumption of CMS separate payment on October 01, building utilization within the VA system, growing our customer-base and expanding the drug's Medicare Advantage and commercial reimbursement – all of which we expect will increase access to OMIDRIA® for ophthalmic surgeons and their cataract surgery patients, improving outcomes and decreasing safety risks."
Details of the Settlement
Omeros had filed the lawsuit against Lupin in 2017 when it had received the Paragraph IV certification from Lupin regarding its filing of an ANDA seeking the FDA's approval to market a generic version of OMIDRIA®. As part of the settlement, Lupin has acknowledged and confirmed the validity of Omeros' patents for OMIDRIA®. These include each of the patents listed in the Orange Book for OMIDRIA®, i.e. US Patent No. 8,173,707, US Patent No. 8,586,633, US Patent No. 9,066,856, US Patent No. 9,278,101, US Patent No. 9,399,040, US Patent No. 9,486,406, and US Patent No. 9,855,246.
Omeros had filed a similar lawsuit against Par Pharmaceutical, Inc. and its subsidiary Par Sterile Products, LLC ("Par"), in 2015 and settled the case with Par in October 2017. Like Lupin, Par had filed an ANDA seeking approval from FDA for marketing the generic version of Omeros' OMIDRIA®. Omeros has used similar settlement terms for settling the lawsuit against Lupin that it had agreed to for settling litigation with Par. As a result of the settlement agreement signed with Omeros, Par and Lupin will not be able to market the generic version of OMIDRIA® till the expiry of its patents. The expiration date of the last-to-expire of Omeros' asserted patents for OMIDRIA® is October 23, 2033.
About Omeros Corp.
Seattle, Washington-based Omeros is a commercial-stage biopharmaceutical Company. It is 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.
About Lupin Ltd
Mumbai, India-based Lupin was founded by Dr. Desh Bandhu Gupta in 1968 and is an innovation led transnational pharmaceutical Company. It manufactures a wide range of quality, affordable generic, and branded formulations as well as API's for the developed and developing markets globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective, and NSAID space. It holds global leadership position in the Anti-TB segment. The Company's drugs are sold in 100+ countries. For FY ended on March 31, 2018, Lupin's consolidated sales was $2.41 billion.
Stock Performance Snapshot
May 25, 2018 - At Friday's closing bell, Omeros' stock slightly fell 0.60%, ending the trading session at $19.72.
Volume traded for the day: 552.59 thousand shares.
Stock performance in the last month – up 33.06%; previous three-month period – up 78.30%; past twelve-month period – up 24.49%; and year-to-date - up 1.49%
After last Friday's close, Omeros' market cap was at $958.19 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
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