With two years to go before biosimilars of its blockbuster Soliris are expected to hit the European market, Alexion is working hard to backstop sales with successor drug Ultomiris. One little complication: A competitor in the wings is touting new Soliris-topping data in an ultra-rare disease, and it could endanger Alexion’s plan.
Apellis Pharmaceuticals’ Apl-2, a late-stage candidate for paroxysmal nocturnal hemoglobinuria (PNH), topped Soliris in improving patients’ hemoglobin levels at 16 weeks, according to phase 3 head-to-head data released Tuesday.
“The majority of patients with PNH currently receiving treatment with (Soliris) have continuing anemia,” said Peter Hillmen, an investigator in the head-to-head study. “The … results show that (Apl-2) has the potential to become a new standard of care for patients with PNH.”
But, so far, analysts don’t seem very concerned with Apellis’ results.
With Alexion’s gung-ho switching campaign to Ultomiris running ahead of plan, the Apl-2 results fall “short by a wide margin” in positioning the drug as a Soliris competitor and should breathe a “sigh of relief” for concerned investors, Piper analyst Christopher Raymond said.
“We see little in these data to indicate any meaningful threat to (Alexion’s) dominance in this space,” Raymond wrote.
Even if Apellis’ positive data does represent a future hit to Soliris’ sales, that impact would likely be “incremental” given Alexion’s “solid execution” in its switching campaign, J.P. Morgan analyst Cory Kasimov said in a note.
“The magnitude of hemoglobin improvement … looks impressive, and we assume much of the debate will now come down to where pegcetacoplan may be positioned in the market,” Kasimov wrote. “Nevertheless, even if there’s a material loss of share in this setting (a small overall segment for ALXN), the impact on our numbers appears rather modest.”
Kasimov put the possible impact in 2025 at around 6% of Soliris’ sales in the worst-case scenario, equivalent to around $500 million.
SVB Leerink analyst Geoffrey Porges was even more scathing of Apellis in his review, saying in a note that Apl-2’s case as a Soliris competitor was “largely overstated” and is “more likely to be effectively offset by the substantial durability of Soliris and Ultomiris.”
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