Positive CHMP Opinion on Glaxo's Vaccine

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GlaxoSmithKline (GSK) 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 2013.

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 include Actelion Ltd. (ALIOF), Jazz Pharmaceuticals (JAZZ) and Bayer (BAYRY). While Actelion and Jazz Pharma carry a Zacks Rank #1 (Strong Buy), Bayer holds a Zacks Rank #2 (Buy).

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