Amicus Therapeutics and Catalent Biologics Enter Strategic Partnership for Gene Therapy Development and Manufacturing
July 02 2019 - 7:30AM
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:
- Collaboration includes multiple active preclinical
lysosomal disorder programs: the current research and
development production technologies and capabilities related to
multiple active preclinical lysosomal disorder programs are being
transferred to and developed at Paragon.
- Adeno-Associated Virus (AAV) manufacturing
platform: establishing an AAV manufacturing platform will
further advance and establish manufacturing for multiple Amicus
preclinical gene therapy programs while leveraging Paragon’s
established manufacturing capabilities for initial clinical supply
and commercial product.
- Pompe preclinical gene therapy program:
Initial technology transfer and process development to focus on
Amicus Pompe AAV gene therapy program.
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
Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated
biotechnology company focused on discovering, developing and
delivering novel high-quality medicines for people living with rare
metabolic diseases. With extraordinary patient focus, Amicus
Therapeutics is committed to advancing and expanding a robust
pipeline of cutting-edge, first- or best-in-class medicines for
rare metabolic diseases. For more information please visit the
company’s website at www.amicusrx.com, and follow on Twitter and
LinkedIn.
About Catalent
BiologicsCatalent Biologics has 20+ years’ experience in
development, manufacturing, and analytical services for new
biological entities, biosimilars, gene therapies 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. 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.
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 TherapeuticsSara Pellegrino, IRCVice
President, Investor Relations & Corporate
Communicationsspellegrino@amicusrx.com(609) 662-5044
Media:Amicus TherapeuticsMarco WinklerDirector,
Corporate Communicationsmwinkler@amicusrx.com(609) 662-2798
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