Sarepta and Catalent Expand Strategic Manufacturing Partnership with Commercial Supply Agreement for Duchenne Muscular Dystrophy Gene Therapy Candidate

Catalent and Sarepta Therapeutics have signed a commercial supply agreement for Catalent to manufacture delandistrogene moxeparvovec (SRP-9001), Sarepta’s most advanced gene therapy candidate for the treatment of Duchenne muscular dystrophy (DMD). The agreement also structures how Catalent may support multiple gene therapy candidates in Sarepta’s pipeline for limb-girdle muscular dystrophy (LGMD).

In November 2022, Sarepta announced that the U.S. Food and Drug Administration (FDA) had accepted its biologics license application (BLA) seeking accelerated approval of delandistrogene moxeparvovec. Under the terms of this expanded agreement, Catalent will be Sarepta’s primary commercial manufacturing partner for this therapy.

“Sarepta is working as quickly as possible to advance new genetic medicines to treat progressive neuromuscular diseases like Duchenne and LGMD. We are excited to strengthen and expand our relationship with Catalent to meet anticipated demand for SRP-9001 and develop commercially scalable processes for additional gene therapy programs in our pipeline,” said Doug Ingram, president and CEO, Sarepta. “We appreciate the years of dedication and collaboration that Catalent has provided in supporting our clinical trials for SRP-9001, and we look forward to continuing our work together through this expanded partnership.”

Alessandro Maselli, president and CEO, Catalent, said, “Our partnership with the Sarepta team spans nearly a decade across multiple programs and modalities, and we look forward to working together to manufacture these potentially life-changing and life-saving products for patients diagnosed with DMD and LGMD. We look forward to leveraging our deep expertise in gene therapy development, manufacturing, and commercialization to support these programs as they advance toward potential regulatory approval.”

Catalent’s gene therapy network includes state-of-the-art facilities that currently house 10 cGMP gene therapy manufacturing suites, with another 8 suites under construction, each capable of accommodating multiple bioreactors up to 2,000-liter scale. For gene therapy development, customers can leverage the company’s UpTempo Virtuoso adeno-associated virus (AAV) platform, a scalable, GMP-ready process for viral vector manufacturing that can reduce a typical 18-month development timeline for drug product by half. Catalent is also the only contract development and manufacturing organization (CDMO) with a facility approved by the FDA for commercial manufacturing of an AAV gene therapy.