We are greatly encouraged by the string of positive news at Alexion Pharmaceuticals, Inc. (ALXN). In September 2011, Alexion Pharma received good news from both the US and European regulatory authorities regarding its drug Soliris (eculizumab).
While the US Food and Drug Administration (FDA) cleared Soliris for the atypical hemolytic uremic syndrome (aHUS) indication, the European Committee for Medicinal Products for Human Use (CHMP) backed its approval for the same indication in the European Union (EU).
We note that Soliris is already marketed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). This is a rare genetic blood disorder characterized by the onset of severe hemolytic anemia, chronic fatigue and intermittent episodes of dark colored urine, known as hemoglobinuria.
The FDA cleared Soliris for treating children and adults suffering from aHUS – an ultra-rare, genetic disorder. The disorder often leads to heart attack, stroke or kidney failure which can be fatal. Soliris is the first and only drug to be cleared in the US for the aHUS indication. The successful US label expansion of Soliris, Alexion’s sole marketed product, is a major achievement for the company which would boost its top line significantly. The drug is expected to be launched in the US by year-end for the aHUS indication.
There was further encouraging news for Alexion last month when Soliris fared well in a mid-stage study which evaluated the drug in another indication. The study involved patients suffering from severe and refractory generalized myasthenia gravis (gMG). Encouraged by the positive results, the company intends to evaluate Soliris for the gMG indication further.
The string of good news justifies our Outperform rating on the stock. We believe that the current price represents an attractive entry point for long-term investors.
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