Incyte's eczema cream Opzelura off to 'very successful' launch despite FDA warning: CEO

When Incyte's Jakafi sister med Opzelura entered the atopic dermatitis market with unexpected FDA safety warnings, industry watchers worried doctors would balk at prescribing the cream. But early results suggest that’s not the case, and one analyst figures the drug could double the Street's 2022 sales expectations.

So far, the launch of Opzelura has been “very successful,” Incyte CEO Hervé Hoppenot said Tuesday. After an official rollout in mid-October, the topical eczema drug reached nearly 19,000 patients in the fourth quarter, which translated into $5 million in sales, he said.

While the $5 million figure came below Wall Street’s prior expectations of $7 million, the rate of patient on-boards suggests Opzelura could reach $148 million in total 2022 sales, well above current consensus estimates of $73 million, RBC Capital Markets analyst Brian Abrahams said in a Tuesday note.

Incyte has ambitious plans for Opzelura: Hoppenot projected the drug could reach $1.5 billion in U.S. eczema sales alone despite a classwide boxed warning about serious infections, death, cancer, heart-related events and blood clots that affects several JAK inhibitors. That outlook seems slightly more achievable recently after Novartis capped its rival topical JAK inhibitor CEE321 after phase 1 data.

As Abrahams sees it, patient uptake is more important than sales numbers during a drug's initial launch period. In January, nearly 11,000 units of Opzelura tubes were shipped from wholesalers to pharmacies, he noted. This data closely reflects prescriptions given the low level of inventories retailers typically hold for specialty dermatology therapies, Barry Flannelly, Incyte’s general manager of North America, said during an investors’ call Tuesday.

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In the few months that Opzelura has been on the market, the drug has already captured 10% new-to-brand post-steroid market share, edging ever closer to the 13% held by Pfizer’s rival Eucrisa cream, which has been on the market for five years, Flannelly said, citing IQVIA data. Sanofi and Regeneron’s blockbuster injection Dupixent continued to lead the space with a 44% share.

Doctor feedback also suggested an increased willingness to use Opzelura. In a recent survey, U.S. doctors said they would start prescribing Opzelura to 6.9 patients on average in February, up from 3.7 in January, according to an Incyte presentation.

On the reimbursement front, Incyte has signed base rebate deals with two of the three largest commercial pharmacy benefit managers covering 55% of patients managed by the two systems, Flannelly said. The company is now working with the two PBMs to remove coverage limitations for the rest of their patients, and with the one remaining PBM on an agreement.

Initial Opzelura sales appeared weak partly thanks to high gross-to-net discounts, including a large effect from the company's patient support program. Incyte expects utilization of the free program to decline as Incyte negotiates coverage. The company hopes the gross-to-net rate will stabilize in the latter half of 2022, Incyte Chief Financial Officer Christiana Stamoulis said on Tuesday’s call.

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As for Pfizer's rival Eucrisa, that drug launch has been tripped up by hefty discounts and unfavorable formulary coverage. Given the large eczema market, the Pfizer topical drug was once billed as a $2 billion-plus asset at peak. But sales have gradually become negligible as the med disappeared from Pfizer’s quarterly reporting.

Meanwhile, as the launch in the large eczema indication gets underway, Incyte could hear from the FDA about Opzelura's potential expansion into vitiligo by April 18. Incyte has also initiated another phase 3 for Opzelura, seeking a standalone label for moderate to severe chronic hand eczema, which affects an estimated 4% of the U.S. population. The study could finish enrollment this year, with a data readout expected in 2023, Incyte’s chief medical officer, Steven Stein, told investors on the call.

Buoyed by the strong initial launch, Incyte now expects Opzelura and its dermatology portfolio—including an investigational JAK1 inhibitor INCB54707—to become a significant revenue driver in the future. In the fourth quarter of 2021, Incyte recorded total revenues of $813 million, up 20% year over year, mainly thanks to Jakafi sales growth.