) recently received a complete response letter (CRL) from the US
Food and Drug Administration (FDA) regarding the company's
influenza vaccine candidate, Q-Pan H5N1 (pandemic influenza A
virus monovalent adjuvanted vaccine).
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The FDA issued the CRL due to an administrative issue. Glaxo
noted in its press release that the issue has already been
resolved and it is working with the FDA to gain approval.
Glaxo is looking to get Q-Pan H5N1 vaccine approved for active
immunization for the prevention of disease in adults who are at
increased risk of exposure to the H5N1 influenza virus subtype
contained in the vaccine.
We note that in Nov 2012, the FDA's Vaccines and Related
Biological Products Advisory Committee (VRBPAC) voted in favor of
the H5N1 vaccine unanimously (14-0). The VRBPAC found the safety
and immunogenicity data on Q-Pan H5N1 to be sufficient to support
approval in adults.
Glaxo has collaborated with the Biomedical Advanced Development
and Research Authority (BARDA) of the US Department of Health and
Human Services for the development of the H5N1 vaccine since
We note that Glaxo boasts of a strong vaccine portfolio which
includes vaccines like Infanrix/Pediarix, Rotarix, Synflorix and
Cervarix. In Dec 2012, the portfolio was further boosted by the
US approval of its influenza vaccine, Fluarix Quadrivalent, for
the prevention of influenza caused by types A and B strains in
adults and children aged 3 years and above.
Glaxo, a large cap pharma stock, carries a Zacks Rank #4 (Sell).
Large-cap pharma companies that currently look better-positioned
Eli Lilly and Company
). All three are Zacks Rank #2 (Buy) stocks.