Update on Alexion’s Soliris

Zacks

Alexion Pharmaceuticals, Inc.'s (ALXN) growth prospects are tied to its sole marketed product Soliris. The drug has been recording strong sales in both its approved indications – paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). However, the drug is very expensive. It is the high price of the drug which has led UK’s National Institute for Health and Clinical Excellence (NICE) to seek clarification from Alexion. The information has been sought by the NICE through the draft guidance produced by its new highly specialised technologies program.

We note that Alexion is seeking approval to sell its highly successful drug in the UK. However, the biopharmaceutical company has been waiting for UK approval for quite a few years now. The NICE, while acknowledging that Soliris was a very effective drug for treating aHUS – a rare blood disorder, has asked Alexion to clarify the high price associated with the drug (£34,200 per adult). The NICE said that Soliris therapy for aHUS patients in the UK would cost £57.8 million to the National Health Service in the first year (assuming approval). The acknowledgement of the efficacy of Soliris for treating aHUS is in line with the positive recommendations issued by the advisory group for national specialised services (AGNSS) and NHS England on the same.

Due to the high cost, the independent advisory committee has asked for additional information from the company such as its research and development costs on Soliris. NICE also intends to seek clarifications from NHS England on the treatment costs before issuing a final guidance to the latter.

Soliris is already available in markets such as the U.S., Japan and the EU for aHUS. Approval of Soliris for aHUS in the UK would further boost the drug’s sales potential. We expect investor focus to remain on updates from the UK on Soliris.

Alexion carries a Zacks Rank #1(Strong Buy). Stocks such as Gilead Sciences (GILD), Alkermes (ALKS) and Biogen Idec (BIIB) carry the same rank as Alexion.

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