Alexion Pharmaceuticals (ALXN) announced that the National Institute for Health and Care Excellence (NICE) has recommended the commissioning of Soliris for atypical hemolytic uremic syndrome (aHUS) patients in England. NICE has recommended Soliris as the first and only treatment for patients with aHUS within the National Health Service in the country.
Soliris is Alexion’s sole marketed product. The product is currently approved in the U.S., EU, Japan and other countries for the treatment of patients with paroxysmal nocturnal hemoglobinuria and aHUS. Alexion is also developing Soliris for other indications including neuromyelitis optica (phase III), myasthenia gravis (phase III) and delayed kidney transplant graft function (phase III).
Earlier this week, Alexion announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted Soliris orphan drug designation for the treatment of patients suffering from neuromyelitis optica. We note that the MHLW grants orphan drug designation to candidates being developed for treating rare diseases (affecting less than 50,000 people in Japan). Moreover, the status makes the drug eligible for 10 years of marketing exclusivity in Japan following approval. This designation also makes Alexion eligible for certain other benefits and incentives, including priority review for the marketing application of Soliris for the NMO indication.
Soliris enjoys orphan drug designation in both the U.S. and EU for the treatment of NMO. Approval for additional indications would boost the drug’s sales potential.
Alexion carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector include Biogen Idec Inc. (BIIB), AMAG Pharmaceuticals, Inc. (AMAG) and Amgen Inc. (AMGN). All three stocks carry a Zacks Rank #1 (Strong Buy).
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