EMA's COMP Positive on Alexion's Soliris


Alexion Pharmaceuticals, Inc. (ALXN) recently announced that the European Medicines Agency’s (:EMA) Committee for Orphan Medicinal Products (:COMP) has rendered a positive opinion on Soliris (eculizumab) for orphan medicinal product designation for the treatment of neuromyelitis optica (NMO). Recently, the US Food and Drug Administration (:FDA) rendered orphan drug designation to Soliris for the same indication.

We note that Soliris is approved in the US, EU and many other countries for the treatment of paroxysmal nocturnal hemoglobinuria (:PNH) and atypical hemolytic uremic syndrome (aHUS). Soliris has orphan drug designation for the treatment of PNH in the US, Europe, Japan and several other countries. The drug also has orphan drug status for aHUS in the US and the EU.

Soliris is the company’s only marketed product and is yet to get approval for the NMO indication in any country.

The drug recorded sales of $1.13 billion in 2012, up 45% and $338.9 million in the first quarter of 2013, up 38%.

Alexion is working on expanding Soliris’ label into additional indications like Shiga-toxin producing E. coli hemolytic uremic syndrome and myasthenia gravis. Alexion’s pipeline also includes asfotase alfa, ALXN1102/ALXN1103 and ALXN1007.

Alexion has been in the news recently with rumors doing the rounds about the company being a potential takeover target. This led to its stock price soaring more than 12% last week. Alexion currently carries a Zacks Rank #3 (Hold). Stocks in the biopharma space, which appear to be more attractive, include Jazz Pharmaceuticals Public Limited Company (JAZZ) , Sarepta Therapeutics, Inc. (SRPT) and Medivation, Inc. (MDVN) with a Zacks Rank #1 (Strong Buy).

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