Alexion Pharmaceuticals’ (ALXN) Soliris was granted an orphan drug designation in the EU for the prevention of delayed graft function (DGF) after solid organ transplantation. We note that the European Commission grants orphan drug designation to those candidates that are being developed to treat, prevent or diagnose diseases or conditions that affect maximum of 5 in every 10,000 patients in the EU.
Last month a similar designation was granted to Soliris in the U.S. for the prevention of DGF in patients undergoing renal transplantation. The orphan drug designation will provide Alexion marketing exclusivity for Soliris in the DGF indication for a certain period of time following approval. Alexion intends to start a single multinational DGF registration study kidney transplant patients on Soliris later in 2014.
We also note that Soliris is currently approved in several countries including the U.S. and the EU for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). The drug is also available in the U.S., EU and other countries for the treatment of atypical hemolytic uremic syndrome (aHUS). Soliris enjoys orphan drug designation for both these indications in the U.S. and the EU.
Soliris, Alexion’s sole marketed product, recorded sales of $1.6 billion in 2013, up 37% year over year, driven by strong sales in both the indications. Alexion expects total revenues for 2014 in the range of $2.0–$2.02 billion, well over 2013 levels. The Zacks Consensus Estimate of $2.03 billion is above the guided range.
The company is also working on expanding Soliris’ label into other indications as well including the prevention of DGF in renal transplant patients. Further label expansions will boost the drug’s sales. We are encouraged by Alexion’s progress with Soliris, and expect investors focus to remain on the drug going forward.
Alexion carries a Zacks Rank #1 (Strong Buy). Some other stocks worth considering include Auxilium Pharmaceuticals Inc. (AUXL), Shire (SHPG) and Endocyte, Inc. (ECYT). All these stocks carry a Zacks Rank #1 (Strong Buy).
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