Novartis upbeat on I/O despite lagging behind competitors
- The tisagenlecleucel (CTL019) advisory committee recommendation has brought Novartis closer to being the first pharmaco to bring a CAR-T to the market, and the company plans to submit in Europe in the fourth quarter of 2017.
- The company confirmed its full-year guidance for 2017, reiterating that it expects sales to be in-line with last year and for core operating income to be in-line or slightly lower than last year.
- Novartis had second quarter sales of $12.2 billion and profits of $2.9 billion, both down slightly year-over-year. The company attributed the decline to generic competition and pricing dynamics.
Only a week ago, Novartis snagged a 10-0 unanimous recommendation for approval at the advisory committee meeting for tisagenlecleucel (CTL019) for pediatric and young adult r/r B-cell acute lymphoblastic leukemia (ALL). Approval could make it the first chimeric antigen receptor T cell (CAR-T) therapy to make it to the market, putting the company firmly in the lead for CAR-T therapeutics, ahead of Kite Pharma.
"This recommendation is transformative. It opens up a new area and allows us to advance out cell therapies," said Vas Narasimhan, global head of drug development and CMO. "It recognizes that the safety profile is well-characterized and manageable, and the manufacturing process is robust. Cryopreservation gives the physicians, patients and manufacturers flexibility and allows us to aim for 22 days from clinic to administration."
Novartis is looking at a number of different payment models for tisagenlecleucel, according to Bruno Strigini, CEO of Novartis Oncology. "We are considering models, including health economics models and pay-for-performance models. We will take into account costs like innovation and manufacturing, and will disclose the price at launch. We are in discussion with payers, and believe that access is likely to be determined on a patient by patient basis, as it is with allogeneic transplants," said Strigini during the second quarter call.
CTL119, Novartis' humanized CAR-T, showed early signs of promise in combination with Imbruvica (ibrutinib), with eight of nine patients showing no signs of chronic lymphocytic leukemia in their bone marrow at three months. The goal is to be able to discontinue Imbruvica.
Novartis is still lagging well behind its competitors on the PD-1 race, but remained upbeat about it on the call. "We believe we have an outstanding portfolio in I/O, with a second generation portfolio that is second to none. We feel very good about it," said Novartis CEO Joseph Jimenez.
A Phase 3 trial is ongoing in melanoma for the PD-1 antagonist PDR001 in combination with Tafinlar (dabrafenib) and Mekinist (trametinib), and a Phase 2 trial has completed enrollment for PDR001 monotherapy in neuroendocrine tumors, with a suggested U.S. filing date for both indications of 2019.
Phase 1b trials of PDR001 with sorafenib in hepatocellular carcinoma, and of PDR001 monotherapy in non-small cell lung cancer and colorectal cancer are ongoing. The company is upbeat on its 2nd generation immuno-oncology pipeline, which includes 18 potential therapeutics in early studies as mono- or combination therapies.
While the company is still seeking bolt-on acquisitions, it has found them harder to find within its specified $2 billion to $5 billion range, according to Jiminez. "We are looking at earlier stage assets to see what we can find in our sweet spot. We will still focus on oncology, pharma and generics, but we will only invest where we can see a clear path to increase our valuation," he added.
- Novartis Earnings Statement
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