) announced that the European Medicines Agency's (EMA) Committee
for Medicinal Products for Human Use (CHMP) has rendered a
positive opinion on its cervical cancer vaccine, Cervarix.
Glaxo is looking to get a two-dose schedule of Cervarix approved
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. Glaxo submitted a Marketing
Authorisation Application (MAA) to the EMA for the same in Aug
The MAA was based on data from a phase III study, in which the
use of Cervarix (two-dose schedule) in girls between 9 to 14
years demonstrated comparable benefit in terms of immunogenicity
to the three-dose schedule of the drug in girls aged between 15
to 25 years.
Currently, a three-dose schedule of Cervarix is approved in the
EU for the above mentioned indication in girls above 9 years.
Meanwhile, a few days back, Glaxo's pandemic Influenza A (H5N1)
virus monovalent vaccine, adjuvanted (Q-Pan H5N1 influenza
vaccine) received approval from the U.S. Food and Drug
Administration (FDA). The FDA approved the vaccine for
immunization of adults for the prevention of disease caused by
the influenza A virus H5N1 subtype present in the vaccine.
Influenza A (H5N1) virus monovalent vaccine, adjuvanted, is also
approved in Europe under the trade name Pumarix.
We note that Glaxo boasts of a strong vaccine portfolio, which
includes vaccines like Infanrix/Pediarix, Rotarix, Synflorix and
Cervarix. Glaxo has a strong vaccine segment, which generated
sales of £2.5 billion in the first nine months of 2013,
approximately 12.5% of the total product sales of the company.
Glaxo carries a Zacks Rank #3 (Hold). Some better-ranked stocks
). While Actelion and Jazz Pharma carry a Zacks Rank #1 (Strong
Buy), Bayer holds a Zacks Rank #2 (Buy).
ACTELION LTD (ALIOF): Get Free Report
BAYER A G -ADR (BAYRY): Free Stock Analysis
GLAXOSMITHKLINE (GSK): Free Stock Analysis
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
To read this article on Zacks.com click here.