Novartis is highlighting six products as key engines for the company’s mid-term growth. Among them, new multiple sclerosis drug Kesimpta and relatively slow-ramping breast cancer med Kisqali earned a special call-out from CEO Vas Narasimhan.
Kesimpta sales in the second quarter reached $239 million, up 24% over the first quarter. The challenger to Roche’s blockbuster Ocrevus got its FDA go-ahead two years ago and has now treated more than 20,000 patients outside clinical trials, Narasimhan said during an investor call Tuesday.
Compared with Ocrevus’ twice-a-year infusion, Kesimpta is a monthly self-administered injection. So far, 77% of patients who have taken Kesimpta remain on therapy at 12 months, “which demonstrates the medicine’s impact as well as its ease of use for patients,” Narasimhan said.
U.S. demand for Kesimpta increased by 18% quarter over quarter. Outside of the U.S., Novartis is still in reimbursement talks in Europe and Canada. The company would expect to start to see more significant sales contributions from ex-U.S. territories in the second half of the year and next year, the chief executive said.
In Asia, where MS rates are lower, a monthly under-the-skin patient-administered treatment option is also very attractive, Narasimhan said, given infrastructure there around infused medicine may not be as well-established as the Western countries, and the opportunity to “deload” the hospital system could be a plus.
While Kesimpta is off to a strong start, CDK4/6 inhibitor Kisqali had been struggling. First approved more than five years ago, Kisqali sales finally hit $308 million in the second quarter, versus $239 million in the first.
Kisqali has had a hard time eating into the large market share held by Pfizer’s Ibrance despite the Novartis drug having shown it could extend patients’ lives in newly diagnosed metastatic breast cancer. By comparison, Ibrance has repeatedly failed to show a survival benefit in several clinical trials.
Most recently, a final analysis of the PALOMA-2 trial showed that the addition of Ibrance to Novartis’ hormone therapy Femara couldn’t prolong lives among frontline patients. Some experts project the latest trial disappointment could cost Ibrance additional market share, but few—if any—think there will be a physician exodus from the CDK4/6 market leader. Besides, Ibrance’s better tolerability profile has also been named as a differentiator among CDK4/6 inhibitors
Novartis is starting to see a “positive trend” on new-to-brand share, Narasimhan said. In the U.S., Kisqali’s new script gains are mainly coming from Ibrance. What’s more, breast cancer diagnoses have just returned to pre-COVID levels, which represents an opportunity for Kisqali to grab market share, he added.
All eyes are now on Kisqali’s NATALEE trial in the post-surgery adjuvant setting. Eli Lilly’s rival drug Verzenio enjoyed fast growth after an expanded approval in certain high-risk early breast cancer patients. Kisqali is eyeing a broader patient population that also includes people with medium-risk diseases.
Data from NATALEE are largely expected toward the end of 2023 unless the trial hits its goal at either of the two planned interim analyses, Narasimhan said. The trial is using invasive disease-free survival as its primary endpoint and measures the proportion of women who are alive and free of invasive breast cancer.
Elsewhere among Novartis’ six growth pillars, heart drug Entresto pulled off a 33% year-over-year growth at constant currencies to $1.13 billion and Cosentyx brought in $1.28 billion in sales after a 12% growth over the same period last year.
Spinal muscular atrophy gene therapy Zolgensma saw sales jump 26% at unchanged exchange rates, with Novartis citing expanded access outside the U.S.
PCSK9 cholesterol drug Leqvio represents another closely watched product. In the second quarter, Leqvio generated $22 million in sales. Novartis said that the drug’s launch will take several years, and the initial focus will be on laying the groundwork for access and education.
Within six months of Leqvio’s launch, 65% of U.S. patients have coverage that aligns with the drug’s label, better than relevant competitor brands including PCSK9 antibodies and other recent anticholesterol launches, Narasimhan said.
Overall, those six drugs together constituted 32% of Novartis’ $10.5 billion innovative medicines sales, which grew 5% at constant currencies but decreased 1% on a reported basis in the second quarter, no thanks to a strong U.S. dollar.
As for Sandoz, the generics deport also enjoyed a 5% sales increase at constant currencies. Novartis slightly dialed up its full-year sales projection for the unit from broadly in line to low-single digit growth. The company reconfirmed that it’ll decide on whether to separate the generics franchise by year-end.