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Novartis gets EU approval for Bexsero meningitis B shot

Offers protection for all ages above two months

Novartis day

Novartis got a major boost to its vaccines division yesterday after winning EU approval for Bexsero, its much-anticipated new meningitis B vaccine.

A green light from the European Medicines Agency (EMA) makes Bexsero the first meningococcal group B vaccine licensed to protect all age groups, including infants aged over two months, in the EU.

Type B meningococcal infections are the largest case of bacterial meningitis in industrialised countries, a devastating infection that can lead to death within 24 hours and cause serious life-long disability. Despite current vaccination programmes meningitis still carries a death rate of around 10 per cent.

Novartis is already vying to get Bexsero included on national immunisation programmes across Europe and says some governments are already interested in early adoption of the vaccine.

Novartis chief executive Joe Jimenez has said in the past that Bexsero is the critical product that could bring its vaccines division - bolted on via the $7.5bn acquisition of Chiron in 2008 - back to profitability after a series of loss-making quarters.

Predictions of the product's annual peak sales potential have ranged as high as $1bn-plus, although analysts polled by Reuters in the wake of EU approval have taken a slightly more conservative stance, putting it in the $700m to $800m range.

As well as Bexsero, Novartis already markets the meningitis vaccine Menveo, which is used to protect against meningitis groups A, C, W135 and Y, and says it can now protect against all five main serogroups of  meningococcal bacteria that "cause the majority of cases around the world".

"This meningitis B vaccine is the most important medical breakthrough in the 30 years since I lost my son to the disease," said Meningitis UK founder Steve Dayman.

"The vaccine must be made widely available through the immunisation schedule as soon as possible - any delay could mean lives lost," he added.

In the US, Bexsero's development was delayed by negotiations with the FDA about the design of phase III trials to support approval, and specifically how to develop a reliable surrogate for efficacy. Novartis has previously suggested that it may bypass development of Bexsero as a standalone product in the US and instead combine it with Menveo into a single jab.

Pfizer is also working on a meningitis B vaccine called MenB rLP2086 but is some way behind Novartis. Last year it said it hoped to start phase III trials of its candidate by the end of 2012.

23rd January 2013

From: Sales, Healthcare



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