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Positive CHMP Opinion on Glaxo's Vaccine - Analyst Blog

Posted: 11/29/2013 4:06:00 PM

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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