Vanda's Sleep Disorder Drug Hetlioz Gains Approval in EU - Analyst Blog
Vanda Pharmaceuticals Inc. VNDA announced that the European Commission (EC) has approved Hetlioz for the treatment of non-24-hour sleep-wake disorder in totally blind adults. We note that the EC has also confirmed orphan drug designation for Hetlioz for this indication. The stock was up in after-hours trading.
The news did not come as surprise as, in Apr 2015, the European Medicines Agency’s Committee for Medicinal Products for Human Use had adopted a positive opinion recommending the approval of Hetlioz.
According to company sources, non-24-hour sleep-wake disorder affects the majority of totally blind individuals. Approximately 130,000 people in the EU suffer from the disorder.
Hetlioz was approved in the U.S. in Jan 2014 (launched in Apr 2014). It is the first and only FDA-approved treatment for non-24-hour sleep-wake disorder. The drug generated sales of $7.5 million in the first quarter of 2015, up 24% sequentially. For 2015, Hetlioz net product sales are expected to be between $40 million and $45 million.
Vanda is working on expanding Hetlioz’s label. The company plans to initiate an interventional study for the treatment of Smith-Magenis syndrome and a pediatric pharmacokinetic study by the end of this year.
Vanda Pharma carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN, AMAG Pharmaceuticals, Inc. AMAG and Avalanche Biotechnologies, Inc. AAVL. While Achillion and AMAG hold a Zacks Rank #1 (Strong Buy), Avalanche carries a Zacks Rank #2 (Buy).
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