Amicus contracts Thermo Fisher to make Batten disease gene therapy

Brammer Bio, now part of Thermo Fisher, will provide clinical and commercial manufacturing capabilities for gene therapy developer Amicus Therapeutics.

Under terms of the deal, Amicus has teamed with Thermo Fisher to support its intrathecal AAV Batten disease gene therapy programs. The agreement includes production of Amicus’ clinical candidates CLN6 and CLN3, with production set to be transferred to Thermo Fisher’s manufacturing sites in Alachua, Florida, and Cambridge, Massachusetts

The contract 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,” Amicus CEO John Crowley said in a statement.

Image: iStock/Kritchanut

“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.”

Thermo Fisher entered the gene therapy space through the acquisition of contract development and manufacturing organization (CDMO) Brammer Bio for $1.7 billion earlier this year. Since the deal closed, Thermo Fisher has said it has set aside $125 million to expand its operation on the back of demand for gene therapy services.

Amicus and Catalent

In related news, Amicus also inked a deal with Catalent’s Paragon Bioservices 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).

“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,” Crowley said.

Amicus is no stranger to working with third-party manufacturers. In February, the firm handed drug substance manufacturing contract to Chinese CDMO WuXi Biologics for its Pompe biologic ATB200, a therapy consisting of recombinant human acid alpha-glucosidase (rhGAA) enzyme with an optimized carbohydrate structure.