SOMERSET, N.J.– July 16, 2019 — Catalent Biologics today announced a long-term strategic agreement for the development and manufacturing of Zolgensma® (onasemnogene abeparvovec-xioi), an AveXis gene therapy treatment for spinal muscular atrophy (SMA).
Through this collaboration, AveXis, a Novartis company, will have dedicated manufacturing space at the new, state-of-the-art commercial manufacturing center near Baltimore-Washington International Airport established by Paragon Gene Therapy, a unit of Catalent Biologics. This additional capacity, along with access to Catalent’s adeno-associated virus (AAV) gene therapy development, manufacturing, and process characterization expertise, will allow for secure market supply of the treatment which is newly approved in the United States. Paragon Gene Therapy will also provide process development for clinical supply of additional viral therapies in the AveXis pipeline.
SMA is a rare genetic disease that leads to progressive muscle weakness, paralysis, and when left untreated in its most severe form, permanent ventilation or death for most patients by age 2. Zolgensma is designed to address the genetic root cause of SMA by replacing the defective or missing SMN1 gene to halt disease progression through sustained SMN protein expression with a single one-time intravenous infusion. Zolgensma is the first and only gene therapy approved by the U.S. Food and Drug Administration for the treatment of SMA, including in patients who are pre-symptomatic at diagnosis.
“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.”
ABOUT PARAGON GENE THERAPY
Paragon Gene Therapy, a unit of Catalent Biologics, is an industry leader focusing on transformative technologies, including gene therapies (AAV), next-generation vaccines, and oncology immunotherapies. Paragon Gene Therapy has two facilities in Baltimore, Maryland dedicated to process development through commercial manufacturing of most scalable AAV platforms across multiple serotypes. Since 2016, Paragon Gene Therapy has completed over 100 clinical GMP AAV batches across 40 programs.
ABOUT CATALENT BIOLOGICS
For more than two decades, Catalent Biologics has built capabilities and experience in development, manufacturing, and analytical services for new biological entities, gene vectors, biosimilars, and antibody-drug conjugates. Catalent has worked with 600+ mAbs and 80+ proteins, and more than 115 clinical trials and 11 marketed products have used GPEx® cell line engineering technology. A further 20 commercially-approved products have employed Catalent Biologics’ capabilities through to aseptic fill/finish. Catalent’s latest addition, Paragon Gene Therapy’s AAV development through commercial-scale manufacturing facilities in Baltimore, Maryland, have produced over 100 clinical GMP batches across 40 programs. Using advanced protein improvement technology and tailored solutions from DNA through to clinical and commercial supply, Catalent Biologics brings better biologic treatments to patients, faster. For more information, visit biologics.catalent.com
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal year 2018 generated approximately $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com
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Zolgensma® is a registered trademark of AveXis, Inc. a Novartis company.