The European Commission today approved Novartis’ meningitis B vaccine Bexsero® for patients two months of age and older—the first time a vaccine has been approved against meningococcus B bacteria.
The EU’s decision allows member states to begin evaluating Bexsero for potential inclusion into their national immunization and reimbursement programs. Novartis said in a statement it is already engaging with governments interested in early adoption of the vaccine.
“Novartis is committed to making Bexsero available as soon as possible,” the company said in the statement, without detailing how soon.
MenB accounts for up to 90% of meningococcal disease cases in Europe and more than 80% of meningococcal cases among infants in Canada. The sooner Bexsero reaches the market, the sooner Novartis can generate the near-blockbuster sales expected for the meningitis vaccine. Estimates range from the $700 million in revenues by 2020 projected by Tim Anderson of Sanford C. Bernstein & Co., to the $1.45 billion by 2016 foreseen by Olav Zilian of Helvea.
Those numbers are expected to enhance the financial health of Novartis’ vaccine and diagnostics division. The division finished 2011 with a $249 million loss on $1.996 billion in revenue, down from the $612 million profit on $2.918 billion in revenue racked up in 2010 following the previous year’s H1N1 flu pandemic. However, when one-time H1N1 revenue was excluded, the division grew 22%, driven especially by vaccines against meningitis; FDA expanded Menveo’s approvals in ’11 to allow children ages 2–10 to take the vaccine.
Bexsero has been in development some 20 years. The EU gave marketing approval to the meningitis vaccine less than a week after The Lancet published favorable results of a pivotal Phase III clinical trial first presented in 2010 at the 17th International Pathogenic Neisseria Conference.
According to the trial results, Bexsero showed both a protective immune response and an acceptable safety profile when given to patients as a three-dose primary series along with routine vaccines. A fourth dose administered at 12 months may contribute to extended protection, researchers found. The clinical trial involved 3,630 infants from two months of age.
Novartis developed Bexsero in the mid-1990s after Rino Rappuoli, Ph.D., global head of research for Novartis Vaccines and Diagnostics, convinced J. Craig Venter to sequence the genome of N. meningitidis. Novartis scientists mined the sequence data to discover dozens of novel proteins that could serve as potential antigens. While no single antigen alone could protect against the diversity of meningitis B strains, investigators found a combination of antigens were essential for the bacterium’s survival, function, or ability to cause infection, and could be found in most MenB strains circulating globally. The four antigens in Bexsero are:
- Neisserial adhesion A (NadA), a protein that promotes invasion of the bacterium and adhesion to human epithelial cells.
- Factor H binding protein (fHbp), which binds with the common blood protein Factor H, enabling the bacterium to evade attack by the host immune system.
- Neisseria heparin binding antigen, which also helps MenB survive in human blood and is present in nearly all strains of meningococci.
- Por A, a protein found in some highly virulent strains of MenB.
“This meningitis B vaccine is the most important medical breakthrough in the 30 years since I lost my son to the disease,” Meningitis U.K. Founder Steve Dayman, MBE, said in a statement.