Approvals in past 5 years: 12
Value of recent approvals: $37.65 billion
Percent of value from recent approvals: 23%
With a dozen approvals to its name in the last five years, Novartis takes the gold on that tally. The list features heavy hitters in the cell and gene therapy field, such as Zolgensma, plus the struggling macular degeneration drug Beovu. The latter med was duking it out with Regeneron’s blockbuster Eylea in the ophthalmology arena before a safety scare largely took it out of the fight.
While Novartis leads the pharma pack by approval volume, the company doesn't fare quite as well when looking at the value it's getting from newly approved medicines.
Overall, the company's entire drug portfolio is worth $164 billion at net present value, according to a recent report by Evaluate Vantage and EvaluatePharma. Novartis' new launches account for about 23% of the total, or $37.65 billion.
Novartis’ gene therapy Zolgensma tops the company's new offerings with a net present value of $7.95 billion, Evaluate says. The therapy won its green light in spinal muscular atrophy (SMA) patients back in 2019, and it inched ever closer to blockbuster territory in 2020 with full-year sales of $920 million. The drug carries an approval to treat SMA patients 2 years and under.
Novartis is looking to get Zolgensma approved in SMA patients up to the age of 5, which could more than double the number of patients eligible for the therapy. The Swiss pharma hopes to accomplish this with a new formulation that’s infused into the spinal fluid instead of intravenously. The company was originally hoping to submit its application in 2021, but thanks to an FDA clinical hold that plan has been delayed. Just this month, though, the FDA lifted the hold, allowing Novartis to resume testing.
The new Zolgensma use could be worth $1 billion in annual sales, Jefferies analyst Peter Welford has said.
Meanwhile, Novartis' breast cancer med Kisqali and the first FDA-approved CAR-T therapy Kymriah take the silver and bronze in the company's new drug value rankings, respectively, according to Evaluate calculations. Kisqali, which won its initial green light in 2017, is worth $5.38 billion versus Kymriah’s $5.03 billion. Kymriah scored an approval in acute lymphoblastic leukemia in August 2017 and clinched an FDA nod in diffuse large B-cell lymphoma the following May.
Kisqali last year drummed up $687 million, a 45% increase at constant currencies, Novartis said in its 2020 annual report (PDF). Kymriah sales clocked in at $474 million, growing 68% year over year.
One Novartis med that's not carrying big commercial expectations? Egaten, which bears a value of $0 by Evaluate’s account. Then again, the drug wasn't intended to be a big seller. Also known as triclabendazole, the drug has been used for years to treat parasitic infections in animals. Novartis scored triclabendazole its first FDA approval in February 2019. The drug is cleared to treat fascioliasis, or liver fluke infection.
Novartis has been donating the drug to the World Health Organization since 2005 but suggested its U.S. approval could “facilitate drug licensing and import to these countries, helping ensure sufficient and prompt availability of the drug when needed.”
Meanwhile, Novartis’ eye drug Beovu is still reeling from a vision-threatening safety flag that arose early last year. Thanks to that setback, coupled with a COVID-19 blow to the overall ophthalmology market, things haven't been looking great for Beovu. The drug generated $190 million in 2020 after its 2019 approval. Evaluate analysts say it's worth about $2.47 billion at net present value. Novartis is looking to push the drug into diabetic macular edema, where safety data appeared better in a recent trial.
As for the rest of Novartis' clutch of new offerings, their value is largely consistent across products. With the exception of Egaten, no other new Novartis approvals carry values below $1 billion. Many carry current values of $2 billion or more.
Breast cancer drug Piqray stands out with a net present value of $4.3 billion, trailed by oncology compatriot Lutathera at $2.77 billion. Meanwhile, sickle cell disease drug Adakveo boasts a value of $2.67 billion, while Mayzent and Xiidra are worth $2.25 billion and $2 billion, respectively, Evaluate analysts said. Bringing up the rear are Rydapt and Tabrecta, worth $1.16 billion and $1.6 billion, respectively.