Lonza and Vertex Pen Long Term Supply Deal for CASGEVY
Drug manufacturer Lonza has announced that it has partnered with Vertex for the long term commercial supply of CASGEVY (exagamglogene autotemcel), the world’s first gene edited cell therapy.
Lonza will manufacture the therapy at their facility in Geleen, Netherlands, with plans to expand production to Portsmouth, NH in the United States in 2025. The Geleen site has been approved by medicines authorities including the US’s FDA, EU’s EMA, and UK’s MHRA for the commercial production of CASGEVY.
CASGEVY is the first cell therapy using the CRISPR/Cas9 gene editing technique. The therapy is pegged to be a one-and-done treatment for patients with transfusion-dependent beta-thalassemia or sickle cell disease.
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"Manufacturing a first-of-its-kind therapy like CASGEVY is complex and requires advanced technology and capabilities,” said Morrey Atkinson, Executive Vice President and Chief Technical Operations Officer.
“The Lonza team have been excellent partners as we have invested in our global manufacturing network to ensure CASGEVY will be available for the patients who need it. We look forward to our continued collaboration."
The agreement outlines that Lonza will provide scientific, regulatory and manufacturing capabilities to Vertex, as well as use of their global manufacturing network.
Daniel Palmacci, President of Cell & Gene at Lonza, said: "It is a privilege to work with Vertex on bringing its innovative and cutting-edge medicines to patients suffering from life-threatening diseases. We are also pleased to reach a significant milestone towards supporting the commercial manufacture of CASGEVY by receiving the regulatory approval at our state-of-the-art cell therapy manufacturing site in Geleen."
