The two companies announced the deal last week. The agreement also outlines 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 Food and Drug Administration (FDA) had accepted its biologics license application (BLA) seeking accelerated approval of delandistrogene moxeparvovec (SRP-9001). Catalent will be Sarepta’s primary commercial manufacturing partner for that 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 CEO.
The CDMO's partnership with Sarepta spans nearly a decade across multiple programs and modalities, noted Alessandro Maselli, Catalent’s CEO. He said the company can leverage its "deep expertise" in gene therapy development, manufacturing, and commercialization to support Sarepta’s programs as they advance toward potential regulatory approval.
Catalent’s gene therapy network includes 10 cGMP gene therapy manufacturing suites, with another eight suites under construction, each, it said, capable of accommodating multiple bioreactors up to 2,000-liter scale.
Market expansion
Maselli provided an outlook for the CDMO’s prospects at the JP Morgan healthcare conference yesterday.
Summarizing key takeaways from that presentation, Julia Qin, analyst at JP Morgan, said Catalent is continuing to see progress in replacing COVID-19 linked revenue with projects focused on, for example, small molecule and gene therapy activities.
And the company sees that CDMOs are now a critical strategic part of the ecosystem for new modalities targeting small populations, and ones that are difficult to manufacture and are asset heavy.
Catalent also reiterated its guidance for FY2023, noting that its full year outlook had factored in the possibility of the macro environment getting worse.
The CDMO, noted Qin, has substantially expanded the size of its total addressable market (TAM).
The New Jersey, US headquartered company estimates its TAM will reach $100bn by 2026, up from the $72bn targeted for FY2023 and the $35bn hit in FY2019. “Management attributes this addressable market expansion to strategic investments that it made specifically within cell and gene therapy, plasmids, and increased presence sterile fill and finish.”