Amicus forms gene therapy manufacturing partnership with Catalent

US biotech Amicus Therapeutics is to work with drug development services company Catalent Biologics to develop its cell and gene therapy manufacturing capabilities.

It has been investing heavily in the field this year, including its $100m acquisition of Celenex last September, bringing with it no fewer than 10 pipeline gene therapy programmes.

Amicus will work with Paragon Gene Therapy, which Catalent acquired earlier this year in a $1.2bn deal to boost its own presence in the fast-developing field.

Amicus has one rare disease medicine already on the market, Galafold for Fabry disease, with an enzyme replacement therapy (AT-GAA) for Pompe disease in its late stage pipeline, to which it has added the gene therapy pipeline and lysosomal storage disorders treatments in early development.

The newly dubbed Paragon Gene Therapy unit is set up to help  development of gene therapies, vaccines, and oncology immunotherapies, and facilitate quick market access.

John Crowley

John F. Crowley, chairman and CEO of Amicus, said: “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 programmes into the clinic as quickly as possible.”

The agreement will also see the development of an Adeno-Associated Virus (AAV) manufacturing platform, supporting the manufacturing of Amicus’ preclinical gene therapy programmes.

The partners will also work on a Pompe pre-clinical gene therapy programme, which will see an initial technology transfer and process development to focus on the Amicus AAV gene therapy programme.

Pete Buzy, president of Paragon Gene Therapy, said: “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.”

The alliance announced yesterday adds to a similar strategic manufacturing collaboration with Thermo Fisher Scientific, the contract development and manufacturing organisation (CDMO) which also has late-stage clinical and commercial-scale capabilities.

Thermo Fisher will supply Amicus with immediate access to clinical and commercial manufacturing capabilities and capacity for its intrathecal AAV Batten disease gene therapy programmes.