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

Soliris
Alexion's Soliris ranks as one of the priciest drugs in the world.

It took longer than some industry watchers expected, but Alexion has another indication for lead med Soliris in the bag.

On Monday, the company said the FDA had greenlighted the product to treat refractory generalized myasthenia gravis (gMG) patients who are antiacetylcholine receptor (AChR) antibody positive—a subset broader than the population treated in Alexion’s trial, Leerink Partners analyst Geoffrey Porges pointed out in a note to clients. SunTrust’s Yatin Suneja called the label a “pleasant surprise.”

All told, Porges expects the green light to pad revenues by $1.2 billion in 2022, and he projects that total will make up 23% of Soliris’ $5.3 billion haul.

Jefferies’ Eun Yang was much more conservative, though, pegging gMG sales at just $500 million in 2025. He called consensus Wall Street estimates, which hover around $900 million, “aggressive.”

RELATED: Alexion says its top brass inappropriately pressed staff to pad Soliris sales

One reason for the lack of enthusiasm? Soliris’ usage and reimbursement “could be a hurdle, particularly ex-U.S.” if dosing puts the cost for gMG use above Soliris cost in its other indications, where it’s already plenty pricey. “We estimate annual list price to be ~$704K in the first year and ~$678K thereafter in the U.S.,” Yang wrote; those numbers put the price of maintenance about 33% higher than Soliris’ recommended maintenance dosing in paroxysmal nocturnal hemoglobinuria.

And while Suneja said he expects gMG pricing to be “similar to” Soliris’ pricing in its other indication, atypical hemolytic uremic syndrome, he also expressed some uptake doubts. “We believe Soliris will likely be reserved for the 5-10% of patients ‘who continue to suffer from severe disease symptoms and complications despite current therapies for MG’ given the drug's high price and potential payer pushback,” he noted.

The way Porges sees it, though, the breadth of the label “is likely to reduce the hurdles for access by payers and to potentially broaden the addressable patient population as well,” although “some payers will no doubt fall back on some version of the clinical trial enrollment criteria,” he acknowledged.

RELATED: Alexion under HHS investigation as part of DOJ Medicare probe

Regardless, the approval—whose at-the-deadline timing Porges called “definitely unusual for what seemed to us to be a relatively straightforward sBLA”—is a positive for Alexion, which has faced its fair share of turmoil in 2017. Multiple sales-practices investigations, executive turnover and a failed Soliris expansion play have marred the year.

“The announcement and label should be well received by investors, and they lift some recent downside risk and allow investors to look ahead to potential positive catalysts ... next year,” Porges wrote.

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