Novartis says it remains confident Kymriah will pull in $200 million in 2019 through the remediation and ramp-up of its CAR-T manufacturing network.

For the third quarter 2018, Kymriah (tisagenlecleucel) netted Novartis $20 million (€17.4 million), making a total of $48 million for the first nine months of the year. The product became the first chimeric antigen receptor (CAR) T-cell to be approved in August 2017.

Elizabeth Barrett, chief executive officer of oncology at Novartis, said the sales figures were above expectations given the manufacturing challenges the firm experienced. In July, Novartis admitted variability in product specifications for the product in the manufacturing of the therapy for its large B-cell lymphoma (DLBCL) indication.

Kymriah brought Novartis $48 million for the first nine months of 2018. Image: iStock/Goldmund

“What we’ve seen is that centers have continued to order Kymriah despite [the manufacturing challenges] because they really think it’s important for their patients to get Kymriah,” she told investors on a financial call. “The good news is we’ve actually been able to deliver the therapy to most of the patients.”

Ramp-up

For 2019, the firm has forecast Kymriah revenues of $200 million, something CEO Vas Narasimhan said is achievable through the fixing of Kymriah’s manufacturing.

“When you look longer-term, you really see a long-term play, and we are quite confident in the profile of the medicine, which is why we invested in resolving the manufacturing issue in the US.”

The firm has also moved forward with plans to ramp-up manufacturing of its CAR-T therapies globally.

“We announced the deal with Cell for Cure in France. We announced we’ll be building a [$92 million] facility here in Switzerland. We announced the China facility [through a 9% stake in Cellular Biomedicine Group] to really give us the global supply chain that we need,” Narasimhan said.

“And the reason we do that… is Kymriah has a really unique profile we’re learning. It’s a profile that hits the sweet spot between strong advocacy and solid safety can be used in the outpatient setting. And when you think longer term about this evolution of this space, it’s really going to be about moving to earlier lines of therapy, where the T cells are less exhausted and you can generate stronger responses.”