Biotech Values

[DewDiligence]

Booster shot of NVS’ Bexsero (f/k/a 4cMenB) enhances efficacy in toddlers:

http://www.novartis.com/newsroom/media-releases/en/2011/1522283.shtml

This Phase III, open-label immunogenicity and tolerability extension analysis included more than 1,500 toddlers who had been administered a three-dose primary series of Bexsero at 2, 4, 6 months. Toddlers were randomized to receive either a fourth (booster) dose of Bexsero concomitantly with measles, mumps, rubella, and varicella vaccine (MMR-V), or Bexsero at 12 months followed by MMR-V at 13 months. Immunogenicity was measured using the hSBA assay and was assessed one month post booster dose.

This study met all primary endpoints. The data show Bexsero to be highly immunogenic in this age group against all vaccine antigens in all MenB strains tested (H44/76, 5/99, NZ98/254), with 11-19 fold increases in hSBA titers.

The PR above also reports data from two other Bexsero studies. Some analysts are predicting blockbuster status for this meningitis-B vaccine, which is a separate product from NVS’ Menveo.