European regulators grant positive opinion for Novartis' MenB vaccine Bexsero

Novartis announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval of its vaccine Bexsero against meningococcal serogroup B (MenB) disease. The company noted that, if approved, Bexsero would be the first broad coverage MenB vaccine to help protect all age groups, including infants.

Novartis reported that the vaccine's tolerability profile and immunogenicity was established through a clinical programme including data from Phase II/III clinical trials involving almost 8000 infants, children, adolescents and adults.

Sanford C. Bernstein & Co. analyst Tim Anderson noted that "Novartis has pinned much of its vaccine division's future prospects on the commercial success of Bexsero." He forecasts the vaccine generating annual revenue of about $700 million by 2020, while Helvea's Olav Zilian predicts sales of $1.45 billion in 2016. However, Anderson suggested Novartis may struggle to win recommendations from public-health agencies to include Bexsero in routine paediatric vaccination schedules because the incidence of MenB has been waning for years. "If the disease occurs only rarely, then it may not make sense to administer the vaccine broadly as a preventive measure," he said.

Earlier this year, Novartis CEO Joe Jimenez indicated he was confident Bexsero would achieve regulatory backing and make the company's vaccines division successful, but added "if that doesn't happen, then obviously we have to rethink that, because we’re not going to continue to accept losses in the division." According to Barclays analyst Michael Leuchten, failure may have led the company to restructure or sell the business.

For further analysis, read ViewPoints: Novartis looks for Bexsero to validate its vaccine offering.

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