- Catalent said Tuesday it had signed a long-term agreement with Novartis' AveXis unit for manufacturing tied to Zolgensma, a gene therapy approved this year and launched at a price that makes it the most expensive drug ever brought to market.
- With the agreement, Novartis gains dedicated space at a new facility near the Baltimore-Washington International Airport built by Paragon Gene Therapy, a Catalent unit acquired in an April deal.
- Paragon Gene Therapy will also help with process development for clinical supply of viral therapies in AveXis' pipeline, Catalent said in a July 16 news release. In addition to Zolgensma, AveXis has two preclinical gene therapy candidates that it hopes to advance into human testing this year or early next.
Working with Catalent gives Novartis another avenue for producing Zolgensma (onasemonogene abeparvovec) and the viruses used to deliver it.
Currently, commercial supply of Zolgensma is produced at an AveXis site in Libertyville, Illinois. The pharma is working to ready two other sites in North Carolina and Colorado as well.
Those efforts appear more aimed at future needs, as Novartis is confident it can supply sufficient quantities of Zolgensma to meet current market demand.
"This year we'll have ample capacity up to 1,000 patients plus and then we'll plan to expand capacity going forward," said Novartis CEO Vas Narasimhan on a Thursday conference call discussing Novartis second quarter earnings.
Zolgensma is designed to treat spinal muscular atrophy, a condition that affects about 500 babies a year in the U.S. Infants born with the most severe type of SMA rarely live more than two years. Zolgensma is designed as a one-time genetic fix, offering to halt progressive muscle weakness.
But the transformative therapy comes with a record-setting price tag — $2.1 million for one dose, which Novartis intends to be paid in $425,000 installments over five years. Insurers have shown some early signs of pushback on the drug's approved label, but generally are covering the therapy.
Novartis is betting that the drug's life-saving benefit will justify the cost for insurers and patients.
For Catalent, the agreement serves as some validation of the $1.2 billion it spent this year to acquire Paragon. Contract manufacturers like Catalent are increasingly investing in the gene therapy field, seeking to support a growing pipeline of experimental therapies.
Paragon recently entered into another gene therapy supply deal with Amicus Therapeutics, a New Jersey-based biotech that's broadened its investment in the space.