Alexion runs toward big Ultomiris goals with early Soliris switching success

Alexion has big goals for Soliris follow-up Ultomiris in paroxysmal nocturnal hemoglobinuria (PNH), and wooing patients over from predecessor Soliris is key. But so far, executives say, those aims are right on track.

As of the end of January—the first full month of the newcomer’s rollout after its Dec. 27 approval—Alexion had switched about 5% of patients over from Soliris, commercial chief Brian Goff said on the company’s fourth-quarter earnings call.

"Alexion’s early commentary about the Ultomiris launch suggests that virtually 100% of new starts for PNH are already with Ultomiris, and that significant switching of established patients is already occurring," Leerink Partners analyst Geoffrey Porges wrote in a note to clients.

All in all, the company is aiming for the 70% conversion mark in two years, and it thinks it can hit it based on "a number of operational components unique to our team," Goff said. For one, Alexion boasts "highly trained field teams" with plenty of experience in the PNH department. And Alexion is prepared: Its product supply is ready, its REMS certification is in place and payer discussions are underway, Goff added.

But most important, he said, is "Ultomiris’ strong clinical profile." And the body of data backing up the drug includes results that show patients can switch safely from Soliris "without requiring a wash-out period."

RELATED: FDA gifts Alexion quick OK for Soliris follow-up Ultomiris

Next up will be Ultomiris rollouts and switching efforts in Europe—beginning with Germany—and then in Japan, executives said. Alexion’s "global, sustainable and durable pricing strategy for Ultomiris" will be key for the drugmaker "as we expand it to new geographies," Goff said.

Of course, Alexion isn’t just looking to convert its existing patients; it’s working to bring in new ones, too. Eighteen months ago, the company had 2,500 PNH and atypical hemolytic uremic syndrome (aHUS) patients on Soliris therapy, but by the end of this year, it’s aiming to double that number to 5,000 patients on either Ultomiris or Soliris.

"In just over two years, we plan to expand our patient base by the same amount that previously required 10 years," Goff said.

Porges, for his part, expects to see a switch rate of 60% to 65% patients with PNH and aHUS—for which Alexion is currently working toward an indication—in major markets by 2021. He raised his near and mid-term revenue forecasts and his price target for the drugmaker after the fourth-quarter call, pointing to results and commentary he called "even better than expected."

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