Good news flowed in at Alexion Pharmaceuticals, Inc. (ALXN) from Europe regarding its drug Soliris (eculizumab). The company recently received clearance from the European Commission (EC) to market Soliris for treating children and adults suffering from atypical hemolytic uremic syndrome (aHUS), an ultra-rare genetic disorder, in the European Union (EU). The disorder often leads to heart attack, stroke or kidney failure, any of which can be fatal.
We note that Soliris, Alexion’s sole marketed product, is already marketed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) — a rare genetic blood disorder.
The successful label expansion of Soliris in the EU does not surprise us since in September 2011, the European Committee for Medicinal Products for Human Use had backed the approval of Soliris for the additional indication in the EU.
Following the EU approval of the drug for the new indication, Alexion intends to enter into discussions with the relevant authorities in major European nations regarding the reimbursement procedure. Moreover, the drug is expected to be launched in major European nations in 2012/2013.
We note that Soliris is already available in the US for treating children and adults suffering from aHUS. The US Food and Drug Administration (FDA) cleared Soliris for the aHUS indication in September this year.
As was the case in the US, Soliris is the first and only drug to be cleared in the EU for the aHUS indication. Consequently, Soliris will target a market with a huge unmet need. The successful US and EU label expansion of Soliris is a major achievement for the company which would boost its top line significantly.
Our Recommendation
Currently, we have an Outperform recommendation on Alexion in the long-run. Our optimism is reflected for the short run too, for which the stock carries a Zacks #2 Rank (Buy rating).
