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Incyte says it has added 2nd manufacturing site to remedy Opzelura production problems

Incyte’s Opzelura is off to a promising launch, as indicated by a variety of metrics the company highlighted on Tuesday, but manufacturing troubles have threatened to hold the atopic dermatitis treatment back.

Incyte has taken steps to solve those issues, and those tweaks have passed muster with regulators, the company said during its first-quarter conference call.

“We have recently received FDA approval and have implemented a new manufacturing process to improve the production of (active product ingredient) for the launch,” Incyte CEO Hervé Hoppenot said.

Incyte also has added a second manufacturing site to produce Opzelura which is “coming onboard as we speak,” Incyte’s chief medical officer, Steven Stein, M.D., said.

“Those units from that second site will—over the next couple of weeks—be out in the field and with patients,” Stein added. “We absolutely expect within the next week or so to begin the sampling program as well, given that now we have a batch made for that.”

Shortly after Opzelura was launched following its approval in September of last year, a handful of customers complained about a texture issue with the topical cream. One patient detected strands of clear crystals.

The company said the issue was caused by some API not being completely dissolved.

“That has obviously been the focus of all our efforts,” Stein said. “We implemented a recent process change via a regulatory process called a CBE30 that improves solubility.”

Sales for Opzelura came in at $90 million for the quarter. The company said that 68,000 new prescriptions have been written for the drug, with 38,000 new patients coming on board in the first quarter.

The company points to a recent survey that showed more than half of physicians expect to increase their Opzelura prescribing in the next three months and more than 60% anticipated that use will more than double over that period.

“In just six months since launch, our 12% new patient share now exceeds that of (Pfizer’s) Eucrisa and (Regeneron and Sanofi’s) Dupixent, highlighting the unmet need for more efficacious treatments for atopic dermatitis patients,” Barry Flannery, Incyte’s GM for North America, said.

Still, there are other concerns with Opzelura. As a JAK inhibitor, it comes with a black box warning.

In addition, the FDA has delayed its decision Opzelura for vitiligo by three months, pushing it to July 18. Incyte said it’s too early to speculate on what sort of market a vitiligo approval would bring.

“In the case of vitiligo, there are no effective therapies now, and as a result, the majority of patients are not currently seeking treatment,” Incyte’s chief financial officer, Christiana Stamoulis, said. “So, it’s a little bit harder to have right from the beginning a sense of how quickly that will change.”

The company reported revenue of $733 million for the quarter, a 20% increase from the same period last year but falling short of Wall Street’s expectation of $764 million.