Catalent, Sarepta expand commercial collaboration with deal for DMD candidate

Catalen (CTLT), the leader in enabling the development and supply of better treatments for patients worldwide, and Sarepta Therapeutics (SRPT), the leader in precision genetic medicine for rare diseases, 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 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, 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."