- Manufacturing was a key focus for Novartis on its third quarter earnings call, as the Swiss pharma has its hands in several of the most challenging areas of drug development.
- The acquisition of Endocyte, announced alongside earnings, gives Novartis two mid- to late-stage radioligand therapies for metastatic castration-resistant prostate cancer. Liz Barrett, head of Novartis Oncology, said the drug giant is evaluating how to leverage Endocyte's technology and experience and improve production practices at Advanced Accelerator Applications, a radiopharmaceutical company it acquired last year.
- Novartis also snagged a couple preclinical CAR-T cell therapy assets from the Endocyte buy. While the pharma already has one of the two marketed CAR-T treatments in Kymriah, manufacturing it has proven quite difficult.
Radioligands, CAR-T medicines, gene therapies: Novartis is working on all of them. That's pushed the big pharma to have a diverse suite of manufacturing capabilities for clinical and, in the case of Kymriah (tisagenlecleucel), commercial supply.
Sales of Kymriah, however, have disappointed Wall Street analysts. In the second quarter, the drug brought in just $16 million. Novartis noted that product variability had become a problem, mostly with regard to adult lymphoma. On the company's most recent call, Barrett highlighted there isn't an expectation the manufacturing issues will delay or end Kymriah trials in large B-cell lymphoma.
"We're actually above our expectations given the manufacturing challenges that we’ve had," she said. "It's hard to tell where we will be if we didn't have the challenges, but I think what we've seen is that centers have continued to order Kymriah despite this, because they really think it's important for their patients to get Kymriah."
In addition to Endocyte and Advanced Accelerator Applications, Novartis acquired AveXis earlier this year for $8.7 billion, outfitting it with a suite of gene therapies.
A filing for AveXis' lead candidate, a spinal muscular atrophy medicine called AVXS-101, is expected before year's end, meaning it could get a Food and Drug Administration approval next year.
Amid Novartis' other production responsibilities, Paul Hudson, head of the company's pharmaceuticals business, underscored that executives are making sure the company is ready ahead of a potential launch.
"Our first indication will be in newborns, and we expect to have a significant demand for that patient population. And we will be ready to match that demand," he said of AVXS-101.