Don’t mistake this for former U.S. President Donald Trump talking, but Novartis is taking a “U.S.-first” approach after lagging its Big Pharma peers in the world’s largest pharmaceuticals market.
Novartis aims to become a top 5 drugmaker in the U.S. by 2027, the Swiss pharma said during an investor event Thursday. Novartis ranked as the fifth largest biopharma company by worldwide revenue in 2021, but it was only 10th in the U.S.
To increase its U.S. presence, Novartis will adopt a “U.S.-first mindset,” increasing the share of U.S. patients in clinical trials and “building capability and talent” in the country, the company said.
Outside of the U.S., Novartis aims to be a top 3 pharma in China, which the company labeled as “a key growth market for the next decade.” The company also wants to maintain its lead in Germany and Japan.
The new strategy comes as Novartis undergoes a major makeover under CEO Vas Narasimhan. Before officially unveiling the “U.S.-first” strategy, Narasimhan has at several occasions articulated an ambition to become a bigger player in the U.S.
Apparently in preparation for the pivot, Narasimhan in April reshuffled Novartis’ innovative medicines department to divide it by U.S. and international markets instead of by therapeutic areas. The U.S. business is now led by Victor Bulto. The reorg is part of a bigger restructuring that will see Novartis cut 8,000 jobs worldwide.
“I think it shouldn’t be underestimated that Novartis is elevating the U.S. organization,” Narasimhan said at the time.
Now, with a planned spinoff of the Sandoz generics unit, Novartis is slated to become a pure-play innovative medicines company.
“Our strategy is focused on five core attractive therapeutic areas, key technology platforms, and the U.S. market, with the aim to increase value per new molecular entity from our deep pipeline,” Narasimhan said in a statement Thursday.
Leading the charge will be eight marketed drugs—Cosentyx, Entresto, Zolgensma, Kisqali, Kesimpta, Leqvio, Pluvicto and Scemblix—each of which hold what Novartis thinks could be multibillion-dollar peak sales potential. Some of the drugs, like Cosentyx and Entresto, are well-known blockbusters on fast growth tracks. Some others, though, like Kisqali and Leqvio, have less certain commercial outlooks.
Kisqali previously had a hard time making inroads into the HR-positive, HER2-negative breast cancer market held by Pfizer’s Ibrance. But the Novartis CDK4/6 inhibitor is seeing “accelerated uptake” these days, Reshema Kemps-Polanco, Novartis’ U.S. oncology head, said during Thursday’s event. Kisqali’s U.S. new-to-brand show is now approaching 30%, compared to just around 10% to 12% a year ago, Kemps-Polanco said.
As for Leqvio, the PCSK9-targeted small interfering RNA therapy is going up against two PCSK9 inhibitors that have had disappointing commercial performance in the cholesterol-lowering market. Novartis believes Leqvio’s less frequent, twice-yearly dosing regimen could offer a convenience edge but has also repeatedly warned that the drug’s launch ramp-up will be slow.
Novartis has set up a U.S-specific marketing strategy to “really address a lot of the non-clinical barriers that have limited the potential of” the antibody drugs, and the company is already seeing “vindication of that strategy,” Mike Exton, Ph.D., Novartis’ global cardiovascular therapeutic area head, said during Thursday’s event.
Rather than a self-administered injection, Leqvio is given by a healthcare provider. Novartis is establishing the administration infrastructure with the country’s top 200 hospital systems, which “takes time and bureaucracy,” Exton said. But, currently, about half of Leqvio’s use is coming from alternative injection centers, he added.
Elsewhere, Pluvicto and Scemblix await important phase 3 readouts that could move them to earlier treatment settings. The phase 3 PSMAfore study is expected to read out later this year or early 2023 and could enable Pluvicto to treat patients with metastatic castration-resistant prostate cancer using a taxane-based chemotherapy. Scemblix will have data in newly diagnosed chronic myeloid leukemia in 2024.