Omeros Corporation and Lonza announced a long-term manufacturing agreement for commercial production of narsoplimab, Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), also referred to as OMS721. Omeros is preparing to submit a biologics license application (BLA) and a marketing authorization application (MAA) to the U.S. Food and Drug Administration (FDA) and to the European Medicines Agency (EMA), 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 a leading drug manufacturer and has a long and proven track record of producing marketed biologics globally,” stated Gregory A. Demopulos, MD, chairman and chief executive officer of Omeros. “Lonza has worked closely with us to accelerate the timing of our BLA and MAA submissions, and we’re confident in Lonza’s ability to produce and maintain the highest quality commercial supply of narsoplimab. We plan to bring the benefits of narsoplimab to patients across a broad range of commercial indications, and we look forward to continuing our strong partnership with Lonza throughout the years ahead.”
“Having worked with Omeros on narsoplimab through development, it is a huge motivation for our teams to continue to support them as they move towards approval of this life-saving drug,” said Karen Fallen, Head of Mammalian and Microbial Development and Manufacturing, Lonza Pharma & Biotech. “Helping to bring drugs like this to market has always been a priority for Lonza – the aggressive timelines and need for agile capacity scale-up depend on close partnership to stay on track. Through this long-term agreement with Omeros, we will be supporting the company as it works to make narsoplimab commercially available worldwide to patients who need it.”