Swiss drugmaker Novartis expects big things from its CAR-T personalized leukemia med, including FDA approval this year, and Oxford BioMedica plans to be along for the ride. The U.K.-based group has nailed down a lucrative new agreement with Novartis to provide the commercial supplies of the lentiviral vectors for the treatment.
Oxford said today it will get $10 million up front and up to $100 million over three years for its services. Better yet, based on their original 2014 agreement, Oxford says it is slated to get “undisclosed royalties” on sales of the drug.
Given that Novartis has already pegged CTL019 as a blockbuster, Jefferies analysts figure the gene and cell therapy group could earn between $84 million and $97 million a year if CTL019 hits peak sales of at least $1 billion a year, Reuters reports.
“The new deal with Novartis will strengthen the group’s balance sheet immediately and will support the group’s continued growth over the next three years,” Oxford Biomedical CEO John Dawson said today in a statement.
Novartis, which is in a race with rival Kite Pharma to win the first FDA approval of a CAR-T med, has a July 12 FDA AdCom meeting date for CTL019 and is anticipating an approval this year.
Producing the lentiviral vector is one aspect of a manufacturing process that will be unlike the production of other kinds of drugs. Instead of a mass-produced biologic, the CAR-T meds require that blood be taken from a patient, cryopreserved, shipped to a facility, reprogrammed to genetically code a patient’s T cells to hunt and kill cancer cells, and manufactured in the lab. Then it is shipped back for infusion into the patient, all in the shortest time possible to try to outrun aggressive cancers.
Novartis, which noted some manufacturing issues when it recently released data from its Juliet trial, has said it expects to be able to complete the process in about 22 days at the time of commercial launch. It said that 10 to 12 of those days make up “the actual cell processing time.” Kite has said it expects to be able to complete its “vein-to-vein” process in 16 to 18 days.