Omeros is preparing to submit a biologics license application and a marketing authorization application to the US Food and Drug Administration and to the European Medicines Agency, respectively, for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
Omeros and Lonza have successfully partnered under a multi-year manufacturing agreement for the clinical supply of narsoplimab.
The new multi-year agreement secures a source of commercial quantities of narsoplimab for use following anticipated regulatory approvals.
Lonza is an integrated solutions provider that creates value along the Healthcare Continuum.
Through our Pharma Biotech and Nutrition segment and our Specialty Ingredients segment businesses, we harness science and technology to serve markets along this continuum.
We focus on creating a healthy environment, promoting a healthier lifestyle and preventing illness through consumers' preventive healthcare, as well as improving patient healthcare by supporting our customers to deliver innovative medicines that help treat or even cure severe diseases.
Patients and consumers benefit from our ability to transfer our pharma know-how to the healthcare, hygiene and fast-moving consumer goods environment and to the preservation and protection of the world where we live.
Founded in 1897 in the Swiss Alps, Lonza is a company with more than 100 sites and offices and approximately 15,500 full-time employees worldwide at the end of 2018.
The company generated sales of CHF 5.5bn in 2018 with a CORE EBITDA of CHF 1.5bn.
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercialising small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers.
The company's drug product Omidria (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is marketed in the US 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.
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 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.
Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Ltd.
Lonza Group Ltd is not subject to the SGX-ST's continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.
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