Vanda Pharmaceuticals Inc.
) shares are up 25.3% on the news that the European Medicines
Agency (EMA) has accepted its Marketing Authorization Application
(MAA) for Hetlioz (tasimelteon). The company is looking to get
Hetlioz approved for the treatment of non-24-hour sleep-wake
disorder (Non-24) in the totally blind.
Hetlioz is already approved in the U.S. for Non-24 where it was
launched this April. It is the first approved drug in this
indication. Hetlioz has orphan drug designation in the U.S. and the
EU for this indication.
We remind investors that Vanda has a license agreement with
) to develop and commercialize Hetlioz. Under this agreement, Vanda
will pay up to $25 million once cumulative Hetlioz sales reach $250
million as well as royalties on net sales of Hetlioz.
According to the company, nearly 130,000 people in the EU suffer
from Non-24 sleeping disorder. This disorder mostly affects people
who are totally blind.
Meanwhile, Vanda is working on strengthening its pipeline. Under an
Eli Lilly and Company
), the company acquired an exclusive worldwide license to develop
and commercialize VLY-686. Currently, VLY-686 is in a phase II
study in patients suffering from chronic pruritus as a result of
Additionally, Vanda has plans to initiate a pediatric study on
Hetlioz for Non-24. We expect investor focus to remain on pipeline
updates as well as Hetlioz's commercialization in the U.S.
Investors looking for well-positioned stocks in the biopharma
sector may consider
Gilead Sciences Inc.
) carrying a Zacks Rank #1 (Strong Buy).
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