During a Q2 earnings call last week, Novartis CEO Vastant Narasimhan told investors its manufacturers had observed “some variability in…product specifications” for chimeric antigen receptor (CAR) T-cell therapy Kymriah (tisagenlecleucel).
The news comes days after Novartis signed a manufacturing agreement with France-based Cell for Cure to make Kymriah at its facility in Paris.
While Narasimhan confirmed its paediatric acute lymphoblastic leukaemia (ALL) launch is advancing as planned, the manufacturing concern relates to Kymriah’s second indication – approved by the US Food and Drug Administration (FDA) in May this year, to treat diffuse large B-cell lymphoma.
CEO of Novartis Oncology, Liz Barrett, told investors variability in commercial specifications isn’t unusual with a new therapy, “as you launch into a new target patient population.”
“[The] commercial label [indicating the percentage of viable cells after manufacturing] is slightly more stringent than what was our clinical study. So what happens, is that some of them are out of spec because they are not at the same level,” said Barrett.
The firm is working to resolve this as soon as possible, we have since been told by a spokesperson: “Our priority goal is to provide this transformative product to patients in both indications, and we have been able to deliver Kymriah to the majority of our patients.
“For cases where the product does not meet commercial specifications, we have developed an Expanded Access Programme path to deliver treatment, when possible.”
The spokesperson did not disclose the specific variability identified in meeting final product commercial specifications.
Patent protection update
Earlier this week, we reported that Novartis had instigated legal action against a number of manufacturers, including Mylan, Teva, Dr. Reddy’s and Biocon, to block generic versions of its multiple sclerosis treatment, Gilenya.
During the investor call, Narasimhan confirmed that Gilenya’s composition of matter patent will expire in Q3 next year, with the dosing regimen patent due to terminate in 2027.
“We believe strongly [in defending] our intellectual property and we have taken action to defend our IP against the generic companies that intend…to launch versus Gilenya next year.
“We are vigorously defending our patents that have been now upheld [by the recent patent decision],” he added.