) 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
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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
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
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
Some better-ranked stocks include
Vanda Pharmaceuticals, Inc.
Forest Laboratories Inc.
). All three carry a Zacks Rank #1 (Strong Buy).