(GSK) GlaxoSmithKline’s Flu Vaccine Approved

GlaxoSmithKline(GSK) recently announced the receipt of marketing authorization for its four-strain seasonal influenza vaccine in Germany and the UK. The vaccine will be marketed as Influsplit Tetra in Germany and Fluarix Tetra in the UK.

The vaccine Influsplit Tetra/Fluarix Tetra helps in the prevention of influenza in adults and children (three years and older) caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine. In Europe, it is the first four-strain influenza vaccine to get approval. It is expected to be launched in the flu season of 2013/2014.

The vaccine gained US Food and Drug Administration (FDA) approval in Dec 2012. The approval was based on three studies, namely, Fluarix-US-005, FLU-056 and Fluarix-062. Moreover, Glaxo is currently seeking approval in Australia, Switzerland and Taiwan. The market also has products like Novartis AG’s (NVS) Aggripal and Sanofi’s (SNY) Vaxigrip and Fluzone.

We note that Glaxo boasts of a strong vaccine portfolio which includes vaccines like Infanrix/Pediarix, Rotarix, Synflorix and Cervarix.

A few days back, Glaxo received a complete response letter (CRL) from the FDA for its influenza vaccine candidate, Q-Pan H5N1 (pandemic influenza A virus monovalent adjuvanted vaccine). 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, a large cap pharma stock, carries a Zacks Rank #4 (Sell). The company that currently looks better-positioned is UCB (UCBJF) which carries a Zacks Rank #1 (Strong Buy).
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