Synageva BioPharma Corp. GEVA announced that it has submitted the New Drug Application (NDA) for Kanuma (sebelipase alfa) to the Ministry of Health, Labour and Welfare in Japan for the treatment for patients suffering from lysosomal acid lipase deficiency (LAL deficiency).
We note that the candidate enjoys orphan drug designation in Japan. Hence, the NDA will receive priority review for marketing authorization, and, if approved, Kanuma would enjoy 10 years of market exclusivity for LAL deficiency. Kanuma would also be the first approved therapy for these patients upon its approval.
Currently, Synageva has no approved products in its kitty. Kanuma is also under regulatory review in the U.S. and Europe for the treatment of LAL deficiency. The company expects a response from the FDA regarding the approval status of Kanuma by Sep 8, 2015. A regulatory decision in Europe is expected in the second half of 2015.
Kanuma enjoys an orphan drug designation in the U.S. and Europe. Additionally, it has received fast track designation and breakthrough therapy designation from the FDA for LAL deficiency in infants.
The company was in the news recently earlier in the month when Alexion Pharmaceuticals, Inc. ALXN announced that it will acquire Synageva for approximately $8.4 billion net of Synageva’s cash. Share prices of Synageva doubled on the news. The deal is expected to close in mid-2015.
Synageva currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care space include Valeant Pharmaceuticals VRX and Gilead Sciences GILD. Both carry a Zacks Rank #1 (Strong Buy).
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