High uptake for Novartis’ meningitis B vaccination programme

Novartis’ first-in-class meningitis B vaccine Bexsero has seen high uptake for the first regional vaccination programme in the world, which is taking place in Canada.

The vaccine is one of the drugs heading to GlaxoSmithKline (GSK) in early 2015 as part of the major deal announced in April in which Novartis and GSK are set to swap key product portfolios for further development, to the benefit of both companies. Such good uptake bodes well for future sales in this arena, although Pfizer is keen to take a share of the market, with its rLP2086 candidate filed for approval at the US FDA in June.

Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) is helping to protect against meningitis B in the Saguenay-Lac-Saint-Jean region, which has had the most cases of the disease in Québec.

A total of 81 per cent of the target population has been vaccinated in the first three months, encompassing more than 45,000 infants, young children and adolescents from two months to 20 years of age.

“A high level of uptake through a public vaccination programme is critical to achieving community-wide protection against a devastating and unpredictable disease like meningitis B,” said Andrin Oswald, division head, Novartis Vaccines. “Thanks to the decisive leadership and urgency with which the public health officials in Québec have acted, lives will likely be saved. We are committed to continuing to work with health authorities globally to ensure public access to Bexsero.”

Meningitis B caused 94 per cent of Québec’s invasive meningococcal disease cases in those aged from one to 24 years old between 2009 and 2011. The decision to implement this vaccination campaign in the region was based on experts’ recommendations, following Bexsero’s approval in Canada in December 2013 for use in individuals aged from two months to 17 years. Second doses of Bexsero will be available in the autumn and the programme will conclude on 31 December.

Bexsero is the first broad coverage vaccine to help protect against meningitis B. Since its launch in 2013, over half a million doses have been shipped worldwide.

It was also recently provided in the US to students at Princeton University and the University of California, Santa Barbara (UCSB) under a treatment Investigational New Drug (IND) designation from the US FDA in response to local meningitis B outbreaks on both campuses.

In June, Novartis submitted a Biologic Licence Application (BLA) to the FDA for US marketing approval of Bexsero, which initiated a rolling submission process, following the receipt of a Breakthrough Therapy designation in April 2014.

Meningitis B is a rare but aggressive disease and is the leading cause of meningococcal disease and septicemia in the developed world. It can kill or cause serious, life-long disabilities within 24 hours of symptom onset, leaving little time for intervention. Vaccination is therefore the best defence against this devastating disease.

Meningococcal disease is most commonly caused by one of the five main serogroups of meningococcal bacteria (A, B, C, W-135 and Y). Prior to the development of Bexsero, vaccines were only available for four of these serogroups, and a vaccine to protect against serogroup B was the remaining piece needed to provide populations with broad-spectrum protection against all five serogroups, which together cause the majority of cases.

Bexsero is approved in 34 countries, including the European Union, Australia and Canada.


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