GlaxoSmithKline (GSK) announced that its cervical cancer vaccine, Cervarix with a two-dose schedule has received approval from the European Commission (EC). The EC approved the vaccine for use in girls between 9 to 14 years for the prevention of premalignant genital lesions including cervical, vulvar and vaginal and cervical cancer causally related to certain oncogenic Human Papillomavirus types.
The EC approval was based on data from two studies (HPV 048 and HPV 070). In the studies it was found that the use of Cervarix (two-dose schedule) in girls between 9 to 14 years showed comparable benefits in terms of immunogenicity and safety to the three-dose schedule of the drug in girls/women aged between 15 to 25 years.
The approval was not surprising considering that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion on Cervarix last month.
Currently, a three-dose schedule of Cervarix is available in the EU for the above mentioned indication in girls above 9 years.
Glaxo carries a Zacks Rank #3 (Hold). We are concerned about the loss of revenues in the third quarter due to investigation in China regarding fraudulent behavior and ethical misconduct. We are also disappointed with pipeline setbacks for two late stage candidates (drisapersen and darapladib). Meanwhile, Glaxo continues to face challenges in the form of EU pricing pressure and generic competition. We expect recent approvals, restructuring and cost-cutting efforts to offset some of the negatives.
Some better-ranked stocks include Vanda Pharmaceuticals, Inc. (VNDA), Jazz Pharmaceuticals (JAZZ) and Forest Laboratories Inc. (FRX). All three carry a Zacks Rank #1 (Strong Buy).
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