The US launch of Pentacel is proving to be a problematic process for Sanofi. Unlike competing products, particularly GSK’s Pediarix, Pentacel’s composition does not match current US vaccination recommendations, which may hinder its uptake until changes in the immunization schedule have been made. The FDA’s recent decision is further delaying the approval of Pentacel in the crucial US market.
Pentacel, Sanofi Pasteur’s combination vaccine against diphtheria, tetanus, pertussis (DTP), polio and as well as Haemophilus influenzae type B (Hib) is currently marketed in nine countries including the UK and Canada, where Pentacel was first registered in 1997. By April 2006, over 13.5 million doses had been distributed in a four-dose injection schedule vaccinating children at two, four, six and 18 months of age.
However, gaining approval for Pentacel in the US has proved difficult for Sanofi, the market leader in the DTP vaccines sector with sales totaling $1.1 billion in 2006. The first submission for Pentacel was made in 2005, followed by an FDA recommendation for pediatric approval in January 2007. The recent FDA announcement to delay a decision on the vaccine until November comes as a result of Sanofi’s decision to shift the control assays for Pentacel’s pertussis component from the company’s Canadian to its US facilities.
The delay in approval is not the only issue associated with the US launch of Pentacel. Although Sanofi’s vaccine would be the first DTaP-based combination product for infants in the US that includes both polio and Hib components, its commercial uptake will be limited by the current national immunization schedules: at this stage, US authorities do not recommend a concomitant vaccination of children under the age of 12 months against DTaP and Hib.
Under the existing regulations, the use of Pentacel would be limited to the fourth DTP booster shot administered at 18 months of age, significantly restricting its initial market uptake. GSK, Sanofi’s strongest competitor in the DTP sector, has avoided this issue by omitting the Hib component from its own DTP combination Pediarix (DTP/polio/HepB), which has become firmly established in the US market following its launch in 2003.
Thanks to the FDA’s decision, GSK will continue to enjoy a leading position at least until the end of the year. Once approved, Pentacel will not emerge as a significant competitor until the CDC amend the current guidelines to recommend concomitant DTaP-Hib vaccination in children aged younger than 12 months.
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