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

Catalent, Inc. and Sarepta Therapeutics, Inc. recently announced the signing of 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 US 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, Sarepta’s President and Chief Executive Officer. “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.”

“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,” said Alessandro Maselli, Catalent’s President and Chief Executive Officer. “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.

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians. Headquartered in Somerset, NJ, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information, www.catalent.com.

Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing. For more information, visit www.sarepta.com.