Alexion ($ALXN) has had a win-some, lose-some year, what with a pricing challenge in the U.K. and a series of recalls for its only marketed drug. But that drug, Soliris, just keeps on surging. Sales grew 39% for the third quarter, hitting $555 million, and profits amounted to $177 million of that.
So, obviously the wins have outweighed the losses. One of those wins: A reimbursement deal in France that not only boosted sales potential going forward, but included $88 million in retroactive payments. That was enough to prompt an 18% hike in the company's earnings forecast for the year.
It was a nice comeback from a smackdown at the U.K.'s cost-effectiveness watchdog, the National Institute for Health and Care Excellence. The agency challenged Alexion's pricing--Soliris topped FiercePharma's recent list of the world's most expensive drugs--for patients with atypical hemolytic uremic syndrome (aHUS), an indication approved in the EU in 2011.
NICE eventually backed Soliris, because aHUS is a rare and serious malady, and the drug can prevent organ damage, making it a "significant breakthrough," agency chief Andrew Dillon said at the time. But the agency imposed some unusual restrictions on use of the drug. An "expert center" will monitor diagnoses and Soliris dosages, and collect data on the potential for lower doses and even halting therapy.
Originally approved in 2007 for the rare disease paroxysmal nocturnal hemoglobinuria (PNH), Soliris won its new indication in aHUS in 2011 in the U.S. and E.U., and 2013 in Japan. The company says Soliris is attracting new patients in both indications around the world.
Alexion has had some trouble with manufacturing, however. The company has recalled Soliris lots three times in recent months, because of particles found in drug vials. Supplies weren't constrained by the problems, but the company has taken charges of more than $10 million to cover the cost of replacing lost inventory.
- read the Alexion release
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