Event - Bexsero approval would help build Novartis meningitis franchise

Potentially one of the biggest biotechnology launches of the year, Novartis’ meningitis B vaccine Bexsero, is due for a decision from European regulators soon, and approval would be a big step toward the Swiss company’s establishing its dominance in the market. With publication yesterday of complete data from the pivotal trial in babies, the first-ever inoculation for meningitis B looks likely to premiere this year.

Launch of a likely blockbuster will come in handy for Novartis, which while not as exposed to patent expiries as many of its big pharma peers still has 40% of its sales at risk in the patent cliff in the near term, particularly the loss of market exclusivity for Diovan later this year (Patent storm hits in 2012, February 8, 2012). With its multivalent vaccine Menveo already a big player in the market, launching the first meningitis B vaccine should go a long way toward establishing the leading meningitis franchise in the space (see tables).

Company Novartis
Product Bexsero
Market cap $130bn
Product NPV $3.28bn
% of market cap 3%
Event type EMA decision date
Date H1 2012

Clear field

Should Bexsero receive European approval, it will have a clear field to work with perhaps for more than two years. Pfizer, which has the world’s biggest selling vaccine in Prevnar 13, is preparing a phase III of its meningitis B vaccine PF-05212366 and Sanofi is developing Meninge B. In either case, a launch before 2015 is unlikely – Pfizer’s trial is scheduled to report at the end of December 2013, making a launch in 2015 the most likely outcome.

There is some urgency to the release of a meningitis B vaccine. Whilst the FDA estimates just 30% of US cases are caused by the B serotype, in Europe the rate is as high as 80% (Therapeutic focus – Novartis set to dominate meningitis vaccine market, November 4, 2010). A US filing is not expected until 2014.

Thus a first-mover advantage may prove vital - with data supporting its use in adults, adolescents, children and babies, Novartis is likely to draw the biggest numbers. Competitors may get a smaller share of adolescents and adults having catch-up vaccinations, and will have to compete for the ongoing market of babies undergoing normal vaccination schedules.

Underscoring Bexsero’s importance to Novartis, it is forecast to be its 10th biggest seller in 2016, according to EvaluatePharma data, with sales of $997m forecast for that year, added to the $517m in sales forecast for Novartis' multivalent vaccine Menveo. Bexsero is also worth $3.28bn to Novartis, representing 3% of the group’s market capitalisation. It will also be the second fastest growing vaccine, behind Pfizer’s Prevnar 13, a pneumonia prophylactic.

Meningococcal B vaccine pipeline
Annual WW Sales ($m)
Status Product Company Pharmacological Class Proprietary Level 2 Launch WW 2011 2016
Filed Bexsero Novartis Meningococcal B vaccine NME 31/03/2012 - 997
Phase II Meninge B Sanofi Meningococcal B vaccine NME - - -
PF-05212366 Pfizer Meningococcal B vaccine NDA 30/06/2014 - 223

Right on schedule

The data published in the Journal of the American Medical Association, from Bexsero’s pivotal phase IIb trial, demonstrated that the Bexsero can be used in conjunction with normal vaccination schedules, at either 2, 4 and 6 months of age or an accelerated schedule of 2,3 and 4 months, without interfering with the immune response from other vaccines.

The bioengineered vaccine, which uses novel antigens identified through a sequencing of the meningitis B genome, induced an effective immune response to two meningitis B strains in 99% of babies vaccinated and 79-86% in a third strain.

Given the medical need and the demonstrated efficacy, anything other than approval by European regulators would be a surprise. Additionally, as there are few clinical stage candidates, Novartis’ head-start should give quite awhile to build its dominance in the meningitis space.

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