Alexion Pharmaceuticals, Inc. (ALXN) 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 (NMO), an ultra-rare neurologic disorder. Alexion is currently enrolling patients with relapsing NMO for a multinational, placebo-controlled registration PREVENT (Prevention of Relapses and EValuation of Eculizumab in NMO Treatment) study on Soliris.
We note that the MHLW grants orphan drug designation to candidates being developed to treat 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.
We remind investors that Soliris had received orphan drug designation in both the U.S. and EU in 2013 for the treatment of NMO.
Soliris is currently approved in the U.S., EU, Japan and other countries for the treatment of patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Alexion is also developing Soliris for other indications including myasthenia gravis (phase III) and delayed kidney transplant graft function (phase III). 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 the three stocks carry a Zacks Rank #1 (Strong Buy).
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