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Lonza and Genetix Biotherapeutics Extend Commercial Manufacturing Agreement for ZYNTEGLO™

Long-term collaboration began in 2013 and enabled commercial approval and rapid uptake for ZYNTEGLO™ in 2022

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Lonza, one of the world’s largest contract development and manufacturing organizations (CDMOs), and Genetix Biotherapeutics Inc. (Genetix), a commercial-stage biotechnology company dedicated to delivering genetic therapies for patients with severe rare diseases, today announced the extension of their long-term commercial manufacturing agreement. Under the expanded agreement, Lonza will expand manufacturing capacity to support growing demand for Genetix’s ZYNTEGLO™, the only FDA-approved gene therapy for pediatric and adult patients with transfusion-dependent beta-thalassemia.

The extended agreement further strengthens the strategic collaboration established in 2013 between Lonza and Genetix, which later enabled ZYNTEGLOcommercial approval in 2022. Under the renewed agreement, commercial manufacturing for Genetix will continue at Lonza’s Houston (US) facility, a dedicated cell and gene therapy site with nearly 10 years of combined clinical and commercial experience supporting the manufacture of this innovative treatment. The collaboration also makes provisions to scale up manufacturing in the future for additional Genetix therapies.

Daniel Palmacci, Head of Specialized Modalities at Lonza, said: “Our extended agreement with Genetix underscores the value of our services and expertise in commercial cell and gene therapy manufacturing. We are proud to continue our collaboration by expanding the commercial production of ZYNTEGLOat our state-of-the-art manufacturing facility in Houston.”

Brian Riley, President and Chief Technology Officer at Genetix, added: “Our long-standing partnership with Lonza reflects our shared commitment to commercial excellence and operational discipline to bring curative therapies to patients impacted by rare disease. Their scientific rigor, quality focus and consistent execution have been important in enabling a reliable supply of ZYNTEGLO. In the last year, patient demand for Genetix’s therapies has grown consistently and rapidly. Extending the agreement with Lonza and expanding capacity provides a strong foundation as we invest to meet the growing patient demand and broaden our long-term manufacturing strategy.”

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