FDA

Alexion bags a blockbuster new approval for its cash cow Soliris. Now what?

Alexion $ALXN has won approval to sell its mainstay therapy Soliris for another batch of patients suffering from an ultra-rare condition — an OK that could well be worth north of a billion dollars.

Ludwig Hantson

Last night the FDA came through with an OK for a subset of patients suffering from myasthenia gravis, setting the stage for a new sales effort that Leerink’s Geoffrey Porges believes will rack up $1.2 billion in sales 5 years from now. That’s close to a fifth of the revenue he’s projecting from Soliris — one of the world’s most expensive therapies — for 2022.

That’s a big win for CEO Ludwig Hantson and the new team at Alexion. Over the past year the biotech has undergone a sea change, punting the previous CEO and CFO in the wake of a sales scandal and ushering in a new regime that is entirely focused on remaking the pipeline at Aexion as they move the company from Connecticut to Boston’s Seaport district.

Alexion, though, is dangerously dependent on Soliris for its future, at a time a number of small biotechs are taking a shot at overturning its blockbuster franchise and carving out market share. This new approval increases the drug’s importance at Alexion as the new crew seeks to diversify, likely through a slate of upcoming deals after rolling out its recent plan to shake up the pipeline.

At $542,640 a year, Soliris remains one of the 10 most expensive therapies on the planet.

Geoffrey Porges

The OK from the FDA is for anti-AchR antibody-positive gMG, which covers about 5% to 10% of the total for that condition. Porges noted this morning:

Based on our recent MEDACorp physician interactions, we believe most of the doctors treating gMG patients have already earmarked a subgroup of patients for whom Soliris is appropriate and intend to begin treatment within the next weeks-month. We believe that recent consensus was still discounting Soliris’ approval and/or commercial opportunity in gMG based on sales estimates (LP $5.3bn vs consensus $4.7bn in 2022). We estimate that gMG will provide an incremental $1.2bn global revenue for Soliris in 2022, representing ~23% of our total $5.3bn projected sales for Soliris in the same year.

“This is a landmark day for the members of the U.S. myasthenia gravis community, who have not seen a therapy approved for generalized myasthenia gravis in more than 60 years,” said Nancy Law, the CEO of the Myasthenia Gravis Foundation of America. “It is particularly significant that this approval of Soliris will provide a new option for those with gMG and especially for those who do not respond adequately to or cannot tolerate standard treatment options.”


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