Amicus Therapeutics and Catalent Biologics Enter Strategic Partnership for Gene Therapy Development and Manufacturing
Supports Clinical and Commercial Supply Needs for Pompe and Other Lysosomal Disease Gene Therapy Programs Advances Amicus’ Mission to Deliver Novel Gene Therapies to Rare Disease Patients CRANBURY, N.J., July 02, 2019 (GLOBE NEWSWIRE) -- Amicus Therapeutics, Inc. (NASDAQ:FOLD) has entered into a strategic manufacturing agreement with Paragon Gene Therapy, a unit of Catalent Biologics, for clinical manufacturing capabilities and capacity for multiple active preclinical lysosomal disorder programs that are currently in development in collaboration with the University of Pennsylvania (Penn). Penn has transferred technology to Paragon in the past and will collaborate with Amicus throughout the process. Amicus has also established a plasmid supply network and long-term supply agreements with industry-leading plasmid suppliers to support advancement of all current gene therapy pipeline programs. Key Highlights of Amicus-Paragon Collaboration:
John F. Crowley, Chairman and Chief Executive Officer of Amicus stated, “As we continue to articulate our near- and long-term Amicus gene therapy manufacturing strategy, our collaboration with Paragon Bioservices is a significant next step in securing clinical scale-up and supply for our Pompe gene therapy, as well as our other active preclinical programs. Advancing a robust manufacturing process and supply is critical to our success. Leveraging our internal expertise and process development in combination with Paragon’s expertise and platform capabilities we hope to expedite the process of moving our preclinical gene therapy programs into the clinic as quickly as possible.” “Amicus has a strong gene therapy pipeline focused on addressing many life-threatening conditions where there are urgent needs for treatments and cures,” said Pete Buzy, President of Paragon Gene Therapy. “Paragon has a proven track record to develop and successfully manufacture complex biotherapeutics using commercially-scalable processes. This agreement with Amicus highlights our world-class manufacturing team and our track record as a center of excellence for gene therapy, trusted by top biopharmaceutical companies.” About Amicus Therapeutics About Catalent Biologics 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. CONTACTS: Investors/Media: Amicus Therapeutics Media: FOLD–G |
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