Paragon Gene Therapy, a contract development and manufacturing organization (CDMO) acquired by Catalent for $1.2bn (€1bn) in May 2019, will supply the clinical manufacturing capabilities and capacity for Amicus’ active preclinical lysosomal disorder programs. These programs are currently in development in collaboration with the University of Pennsylvania (Penn).
The biotechnology company, Amicus, is focused on the discovery and development of treatments for rare metabolic diseases and its multiple active preclinical programs are particularly focused on gene therapy.
Penn has transferred technology to Paragon for manufacture and will collaborate with Amicus throughout the agreement between the two companies.
According to John Crowley, CEO of Amicus, this collaboration with Paragon is a significant step in its gene therapy manufacturing strategy as it secures clinical scale-up and supply for its Pompe gene therapy and other active preclinical programs.
To support these programs, Amicus established a plasmid supply network and long-term supply agreement to support the advancement of all its current gene therapy pipeline programs.
“Advancing a robust manufacturing process and supply is critical to our success,” said Crowley. Through this agreement, the company hopes to expedite the process of moving its preclinical gene therapy programs into the clinic.
On May 29, 2019 the company announced a public offering of common stock. A spokesperson for the company told us part of the proceeds will be used to complete the design and build of the Amicus Process Science and Gene Therapy Manufacturing facility.
Additional AAV collaborations
Additionally, Amicus recently entered an agreement with Thermo Fisher Scientific and its recently acquired Brammer Bio. This agreement sees Brammer providing clinical and commercial manufacturing for Amicus’ intrathecal adeno associated virus (AAV) Batten disease gene therapy programs. Amicus’ spokesperson told us this will not impact the agreement with Paragon.
Paragon also recently entered another manufacturing agreement for a supply for a preclinical gene therapy program. It will produce the AAV vectors for Iveric Bio’s preclinical and clinical trial supply lead drug candidates.