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Alexion Pharmaceuticals' Kanuma Gains Approval in Japan

Alexion Pharmaceuticals, Inc.ALXN announced that the Japanese Ministry of Health, Labour and Welfare has approved the company's enzyme replacement therapy, Kanuma (sebelipase alfa), for the treatment of patients of all ages suffering from lysosomal acid lipase deficiency (LAL-D).

Following approval, Kanuma is the first therapy to be cleared in the country for the treatment of this life threatening and ultra-rare metabolic disorder, thereby indicating an untapped market for the drug. The company expects initial patients with LAL-D in Japan to start commercial treatment with Kanuma in the third quarter of 2016.

We note that Kanuma is already marketed in the U.S. and Germany for the same indication. It gained FDA approval in Dec 2015 and was subsequently launched in the U.S. in Jan 2016. Along with this approval, the company received a rare pediatric disease priority review voucher.

EU approval came in the third quarter of 2015. Reimbursement discussions in individual countries in other major EU countries are ongoing. The company expects launches outside Germany in the second half of 2016 with additional launches to follow in 2017. Geographical expansion would boost the drug's commercial potential.

We remind investors that Kanuma became a part of Alexion's portfolio following the Jun 2015 acquisition of Synageva. We expect investor focus to remain on the commercialization and sales ramp up of Kanuma.

Alexion is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK , Actelion Ltd. ALIOF and AMAG Pharmaceuticals, Inc. AMAG . All three stocks carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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