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GSK receives favourable FDA recommendation

GlaxoSmithKline's rotavirus vaccination drug, Rotarix, received a further boost to its implementation schedule after the Food and Drug Administration gave it a favourable recommendation.

GlaxoSmithKline's (GSK) rotavirus vaccination drug, Rotarix, received a further boost to its implementation schedule after the Food and Drug Administration (FDA) gave it a favourable recommendation.

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) reached a unanimous agreement, it was announced on February 20, that data supporting GSK's claim for Rotarix's efficacy was adequate.'

Rotavirus diarrhoea and dehydration can affect children as young as three and if the FDA gives GSK final approval for the vaccine, Rotarix could be integrated into two and four-month immunisation visits.

Dr Barbara Howe, vice president and director of North American vaccine development for GSK, said: "If approved, we believe Rotarix, which was developed to mimic the protective effects of natural infection, would offer an important option in completing rotavirus vaccination by four months of age."

Having already been successful at the Biologics License Application (BLA) stage, Rotarix could potentially generate between £1bn and £1.3bn worldwide [PMLive February 15].

Rotarix clinical and legislative progression comes at a turbulent time for the pharmaceutical industry and GSK in particular, the shares of which fallen nearly 40percent.

Shedding further light on current difficulties, Jean-Pierre Garnier, chief executive of GSK will appear in a CNBC interview on February 21 (2130 GMT) and describe how Glaxo Wellcome and SmithKline Beecham tried to avoid a merger deal.

"We didn't want to merge because we were afraid of the size of the combined company," said Garnier who explained that the two companies initially wanted to create a joint R&D institute. "We tried for six months to make this model work, which would not have been a full merger, and we realised we couldn't do it"

Garnier is due to retire as chief executive in May 2008.

21st February 2008

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