Amicus Therapeutics and Brammer Bio, a part of Thermo Fisher Scientific, Enter Strategic Gene Therapy Development and Manufac...
July 01 2019 - 7:00AM
Amicus Therapeutics, Inc. (NASDAQ:FOLD) has entered into a
strategic manufacturing collaboration with Thermo Fisher
Scientific1. Thermo Fisher, a best-in-class contract development
and manufacturing organization (CDMO) with late-stage clinical and
commercial-scale capabilities provides Amicus with immediate
clinical and commercial manufacturing capabilities and capacity for
the Amicus intrathecal AAV Batten disease gene therapy programs.
Amicus has also established a plasmid supply network together with
multiple long-term supply agreements from industry leading plasmid
suppliers to support advancement of all current gene therapy
pipeline programs in the Amicus portfolio.
Key Highlights of Amicus-Thermo Fisher
Scientific Partnership:
- Batten disease programs: current research and
development production technologies and capabilities related to the
Amicus preclinical and clinical-stage gene therapy programs for
CLN6, CLN3, and other potential Batten disease programs are being
transferred to and developed at Thermo Fisher’s viral vector
services business.
- CLN6 Batten disease gene therapy: the existing
process for the CLN6 Batten disease gene therapy is being
transferred to Thermo Fisher and undergoing a similar GMP process
for clinical and commercial-scale manufacturing and supply.
- Broader portfolio: Thermo Fisher and Amicus to
collaborate to develop platform manufacturing capabilities to
support the broader portfolio of AAV gene therapy programs
John F. Crowley, Chairman and Chief Executive
Officer of Amicus stated, “As we advance one of the industry’s
leading gene therapy pipelines, our partnership with Brammer Bio,
now part of Thermo Fisher, is a significant next step in fulfilling
our manufacturing strategy so that we can deliver novel gene
therapies to more people living with rare genetic diseases as
quickly as possible, especially in devastating diseases like
Batten’s, where time is of the essence. With our decade of
experience in biologics manufacturing, we understand the
importance and complexities of technology transfer during the drug
development process. We look forward to embedding our Amicus team
and other strategic partners in the tech transfer process to Thermo
Fisher, and to further augmenting our manufacturing capabilities
and partnerships across our entire gene therapy portfolio.”
"We are thrilled to begin working with Amicus
and to contribute to the successful development of their gene
therapy pipeline," said Chris Murphy, vice president and general
manager, viral vector services at Thermo Fisher Scientific. "We see
this as a strong strategic relationship to enable manufacturing of
a deep gene therapy pipeline across various stages of development
for people with devastating genetic diseases. These therapies have
the potential to transform patients' lives and, as an organization,
we are delighted to support partners such as Amicus as they advance
tomorrow's potential medicines."
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.
____________________
1 On May 1, 2019, Thermo Fisher Scientific
announced that Brammer Bio would be integrated into Thermo Fisher
Pharma Services.
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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