Omeros Corporation, a biopharmaceutical company, discovers, develops and commercializes small-molecule and protein therapeutics for large-market, as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system. The company’s proprietary PharmacoSurgery platform is based on low-dose combinations of U.S. Food and Drug Administration-approved (FDA-approved), therapeutic agents delivered directly to the surgical site throughout the duration of the procedure to inhibit preemptively inflammation and other problems caused by surgical trauma and to provide clinical benefits both during and after surgery. In its pipeline the company has clinical-stage development programs focused on: complement-related thrombotic microangiopathies; complement-mediated glomerulopathies; Huntington’s disease and cognitive impairment; addictive and compulsive disorders; and problems associated with urologic surgical procedures. In addition, the company has a group of preclinical programs and two additional platforms: one capable of unlocking new G protein-coupled receptor (GPCR), drug targets and the other used to generate antibodies. OMIDRIA (phenylephrine and ketorolac injection) 1%/0.3% The company’s marketed drug product OMIDRIA (phenylephrine and ketorolac injection) 1%/0.3% was broadly launched in the U.S. in 2015 for use during cataract surgery or intraocular lens (IOL), replacement. OMIDRIA is derived from the company’s proprietary PharmacoSurgery platform, which is designed to improve clinical outcomes of patients undergoing ophthalmological, arthroscopic, urological and other surgical procedures. For OMIDRIA and each of its product candidates and its programs, other than OMS103, the company has retained control of all commercial rights. The company launched OMIDRIA in the U.S. in 2015 primarily through wholesalers which, in turn, sell to ambulatory surgery centers (ASCs), and hospitals. The Centers for Medicare and Medicaid Services (CMS), has granted transitional pass-through reimbursement status for OMIDRIA, which it expects to run until January 1, 2018. It has also confirmed coverage for OMIDRIA with all of the 30 major commercial third-party payers in the U.S., as well as a large number of regional commercial payers. In 2015, the company launched the OMIDRIAssure Reimbursement Services Program, or OMIDRIAssure. The OMIDRIAssure coverage and reimbursement support services for surgeons and facilities remove uncertainties about coding, billing, and coverage of OMIDRIA. European Union and other International Territories In 2015, the company received approval from the European Commission to market OMIDRIA in all EU member states plus Iceland, Lichtenstein and Norway for use during cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), to prevent miosis (pupil constriction), and to reduce postoperative eye pain. OMS103-Arthroscopy OMS103, derived from the company’s PharmacoSurgery platform, was developed for use during all arthroscopic procedures, including knee and shoulder arthroscopy, and completed Phase 3 trials in patients undergoing arthroscopic anterior cruciate ligament reconstruction and arthroscopic partial meniscectomy. In 2015, the company entered into an exclusive licensing agreement, or the OMS103 Agreement, with Fagron Compounding Services, LLC, doing business as Fagron Sterile Services, and JCB Laboratories, LLC, or collectively Fagron, an FDA-registered human drug outsourcing facility, under which Fagron is obligated to produce under Good Manufacturing Practice, and to commercialize OMS103 in the U.S. Mannan-binding lectin-associated serine protease-2 (MASP-2) Program - OMS721 - Lectin Pathway Disorders The company is developing MASP-2 antibodies and small molecules. OMS721 is the company’s lead human monoclonal antibody targeting MASP-2. OMS721 has received Orphan Drug designation for the prevention (inhibition) of complement-mediated TMAs, and Fast Track designation for the treatment of patients with aHUS. The company holds worldwide exclusive licenses to rights related to MASP-2, the antibod
omeros corp (OMER:NASDAQ GM)
201 Elliott Avenue West
Seattle, WA 98119
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