Lonza Supply Agreement

Alberto Santagostino, SVP Head of Cell – Gene Technologies, Lonza Pharma – Biotech, said: “The mesoblast is a true pioneer, pioneer in the development of life-changing cell therapies and works hard to quickly make them available to a large number of patients. This agreement builds on the successful partnership and alliance between our two companies over the years. Given that, on the one hand, we are also entering into new partnerships with start-up companies, Mesoblast is showing the way to successful marketing. We are committed to long-term mesoblast to continue to grow and provide cell therapies together to all patients in distress. “Lonza is a leading pharmaceutical manufacturer and has a long and good state of success in the global production of commercially marketed biologist products,” said Gregory A. Demopulos, President and CEO of Omeros. “Lonza has worked closely with us to accelerate the timing of our blah- and MAA bids, and we are confident that Lonza is able to produce and maintain the highest quality narsoplimabab commercial supply. We plan to bring the benefits of Narsoplimab to patients across a wide range of business indications, and look forward to continuing our strong partnership with Lonza in the years to come. Dr. Silviu Itescu, Chief Executive Officer of Mesoblast, said: “This commercial manufacturing agreement with Lonza for our lead product candidate is designed to ensure that we are able to meet the expected commercial demand, as we plan to bring the first of our allogeneic cell therapies to people around the world who need disease replacement and prevention products. Melbourne, Australia and New York and Basel, Switzerland, October 16, 2019 (GLOBE NEWSWIRE) — Mesoblast (ASX:MSB); Nasdaq:MESO) and Lonza (SWX: LONN) announced today that they have reached an agreement for the commercial manufacture of lead-allogen-product candidate (off-the-shelf), Remestemcel-L for alveolar transplants refreezing to host disease (AGVHD).

This agreement will facilitate inventory development prior to the planned release of Remestemcel-L and U.S. commercial supply to meet the mesoblast`s long-term market forecasts. “After working with Omeros on Narsoplimab through development, our teams are very motivated to continue to support them while moving towards the approval of this life-saving drug,” said Karen Fallen, Director of the Microbe Development and Manufacturing Department, Lonza Pharma-Biotech. “Helping to bring drugs like this to market has always been a priority for Lonza – aggressive schedules and the need for agile capacity increase depend on a close partnership to stay on track. Through this long-term agreement with Omeros, we will help the company market Narsoplimab worldwide for patients who need it. The agreement calls for Lonza to expand its cGMP facilities in Singapore if necessary to meet long-term growth and product capacity needs. It also expects the introduction of new technologies and improved processes, which should significantly improve yields and efficiency.