Despite COVID-19 and safety woes, Novartis still eyes blockbuster sales for Beovu

Novartis’ newly launched wet age-related macular degeneration med Beovu was hit by a double whammy: the negative impact of COVID-19 on the overall ophthalmology market and a new safety flag. But the Swiss pharma still sees it as a future blockbuster.

Beovu sold $68 million in the first quarter, against the backdrop of Novartis’ ophthalmology franchise being “clearly the one that’s most affected by COVID,” Novartis pharma chief Marie-France Tschudin said on a Tuesday conference call.

Clinic visits and prescriptions for eye therapies dropped week by week in March and April, Tschudin said. Beovu and Roche-partnered Lucentis, both anti-VEGF drugs, are administered by physicians, and elderly patients with the retinal disease are already vulnerable to infections, she explained.

Total anti-VEGF scripts in the U.S. declined 15% sequentially in the four weeks ending April 10, as new-to-brand scripts fell 12%, Tschudin said, citing IQVIA data.

Nevertheless, Beovu’s Q1 haul beat industry watchers’ expectations by about 70%. That’s probably because analysts already held very low expectations from the med, what with a surprising new safety problem.

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In February, the American Society of Retina Specialists warned its members of occlusive retinal vasculitis that can lead to vision loss with Beovu use. After an analysis of post-marketing safety reports, Novartis confirmed the adverse event findings in early April and is updating the drug’s label to include language about potential vision loss.

CEO Vas Narasimhan stressed that the incidence is very rare, with about 1 to 2 cases in 10,000 injections. The company’s now working with retina experts to understand the root cause and to figure out ways to mitigate the safety concerns. Specialists are “really keen” to help with that effort, which Tschudin attributed to the drug’s efficacy. She did acknowledge the process may take some time, “but we also have a long exclusivity in the U.S. and EU, so we will play the long game on this one.”

“We still believe that this product will be a blockbuster,” Tschudin said. According to her, only about half of healthcare centers continue to order Beovu, though it's unclear how much of that step back is the pandemic’s doing.

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Outside of ophthalmology, sales from spinal muscular atrophy gene therapy Zolgensma hit $170 million in the first quarter, 15% below the Street’s consensus. In the drug’s current indication of children less than 2 years old, it’s treating around 100 patients per quarter in the U.S., Narasimhan said. But the coronavirus did dampen the Q1 performance, as fewer patients are coming in switching from Biogen’s Spinraza.

Novartis is working with the FDA to resolve a clinical hold on testing the high dose of an intrathecal formulation of Zolgensma, which could allow it to reach older patients. It’s on track to meet with the agency in the second quarter to understand the data required for a filing, Narasimhan said. Previously, the company had said it believes it can apply with just the low-dose results.

COVID-19-related drug stocking helped drive Sandoz sales up 9% to $2.5 billion, even though price erosion cost it 4 percentage points. Antitrust scrutiny recently forced Novartis and India’s Aurobindo Pharma to ditch their U.S. oral solids and dermatology transaction. Now, the generics unit’s sales are expected to suffer about 1 percentage point in 2020, the Swiss pharma figures.

Overall, Novartis’ Q1 haul totaled $12.28 billion, up 13% at constant currencies, with an estimated $400 million contribution from forward purchasing that’s expected to reverse for the rest of 2020. The company has maintained its full-year guidance, projecting sales to grow by a mid- to high-single-digit percentage.