Alexion aims for best-ever Soliris launch with new myasthenia gravis indication

Alexion's Soliris won an indication in generalized myasthenia gravis in October.

SAN FRANCISCO—Alexion’s rollout of Soliris in generalized myasthenia gravis (MG) won’t be just any launch for the rare-disease product. The company thinks it can make the kickoff its best ever.

“We expect that the MG opportunity and launch will be at or above” the company’s launches for Soliris in paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), CEO Ludwig Hantson, Ph.D., told investors on Monday at the J.P. Morgan Healthcare Conference.

So far, Alexion is “very pleased with physician and patient enthusiasm” around the first-in-class treatment for the muscle weakness condition, and it’s also amped about its label—which is broader than industry watchers expected—and initial payer coverage, which Hantson said mirrors the company’s phase 3 study population.

And while starting some patients on treatment has taken a little longer than usual with “the holidays impacting scheduling and timing of funding,” Hantson said, “we do expect acceleration of treatment initiation as we enter the beginning of the year.”

RELATED: Alexion's Soliris wins $1B myasthenia gravis approval with broader-than-expected label

To help that process along, the company is relying on its OneSource support program, which already has 160 patients enrolled. Through that program, nurse case managers can assist patients and physicians with benefit verification, vaccination options and other hurdles related to starting up with Soliris.

When all is said and done, some analysts think Alexion may just have a blockbuster indication on its hands; Leerink Partners’ Geoffrey Porges, for one, has pegged Soliris' 2022 gMG sales at $1.2 billion.

The company could use that boost, considering that fellow launch med Kanuma is still struggling. The lysosomal acid lipase deficiency product, acquired through Alexion’s $8.4 billion buyout of Synageva, racked up just $31 million in U.S. sales through the first nine months of 2017. “The team is really working hard and also smart in order to upgrade Kanuma’s launch trajectory,” Hantson said.

Meanwhile, Alexion is looking beyond Soliris with ALXN1210, a longer-acting follow-up to its leading moneymaker. The company expects phase 3 studies in PNH to read out in the second quarter, and it’s plotting regulatory submissions in the U.S., Europe and Japan for the second half of this year.

“We are on a strong path to raise the bar in PNH and aHUS with ’1210,” Hantson said.