) 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 £1.5
billion in the first half of 2013, approximately 11% of the total
product sales of the company.
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Glaxo's vaccine pipeline comprises several late-stage candidates
including MAGE-A3 for melanoma and non small cell lung cancer and
RTS,S for the prevention of malaria.
Data from a phase III study on RTS,S showed that the vaccine is
effective in preventing malaria up to 18 months after vaccination
of young children and infants. Additional data from a follow-up
study at 32 months and the impact of a fourth booster dose
administered 18 months after the initial three doses are expected
Glaxo plans to submit a regulatory application for RTS,S to the
European Medicines Agency (EMA) in 2014 with an application for
the Committee for Medicinal Products for Human Use's (CHMP)
scientific opinion. A positive CHMP opinion on RTS,S will make it
easier for Glaxo to submit marking applications in African
countries. A final regulatory decision from the European
Commission (EC) is expected in 2015.
Its crucial for Glaxo to get RTS,S approval in African countries
as approximately 660,000 children die every year in sub-Saharan
Africa due to malaria.
Glaxo, a large cap pharma company, carries a Zacks Rank #3
(Hold). We are pleased with Glaxo's pipeline development efforts.
A number of pipeline-related news is expected in the coming
quarters including the U.S. Food and Drug Administration's (FDA)
decision of UMEC/VI (PDUFA date: Dec 18, 2013). Given the
declining sales due to generic competition, we believe Glaxo's
pipeline is under pressure.
Other large-cap pharma stocks such as
) currently appear to be more attractive. While Roche carries a
Zacks Rank #1(Strong Buy), Bayer and Allergan carry a Zacks Rank