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Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma.
Catalent Biologics has announced, in a July 16, 2019 press statement, that it has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma (onasemnogene abeparvovec-xioi).
Under the terms of the agreement, Novartis company, AveXis, will have dedicated manufacturing space at a new commercial manufacturing center near Baltimore–Washington International Airport, which has been established by Paragon Gene Therapy-a unit of Catalent Biologics. In addition, Paragon Gene Therapy will provide process development for the clinical supply of additional viral therapies within the AveXis pipeline.
“We are pleased to add additional manufacturing capacity and technical expertise through this collaboration as we rapidly scale up product production,” commented Andy Stober, senior vice president of Technical Operations for AveXis. “We look forward to working with Catalent in continued service of the SMA community.”
“We are honored to be a partner in this transformational journey,” added Pete Buzy, Catalent’s president, Gene Therapy. “This collaboration allows us to leverage our new state-of-art GMP commercial manufacturing facility and AAV development and scale-up expertise to support AveXis from the early development stage to this critical launch. We work tirelessly to support a patient-first culture, and we are fully committed to be a premier collaborator with AveXis as they deliver this incredible new treatment for patients.”
Zolgensma is a gene therapy that has already been approved by the US FDA for the treatment of SMA and includes treatment of patients who are pre-symptomatic at diagnosis. The therapy works by replacing the defective or missing SMN1 gene, which halts disease progression, with a one-time intravenous infusion.