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Pfizer reports progress with meningitis vaccine

Race to US market heats up

Pfizer headquartersPfizer will present new data on its meningitis B (menB) vaccine candidate rLP2086 this week as it tries to close the gap with rival Novartis.

Pfizer is in a race to market in the US with Novartis for its menB vaccine, although the latter’s Bexsero is already available in Europe, Canada and Australia and picked up this year’s UK Prix Galien in the Innovative Product category.

New phase II data to be presented this week at the IDWeek annual meeting in Philadelphia shows that rLP2086 is safe and effective when administered alongside Merck & Co’s human papillomavirus (HPV) vaccine Gardasil to children aged 11 to 17. There was no impact on the effectiveness or tolerability of Gardasil, according to Merck.

The data – which is important as a new vaccine must be shown to be compatible with others used in immunisation programmes if it is to be adopted for routine use – backa up earlier phase II trials of rLP2086 that showed it could elicit an effective immune response against Neisseria meningitidis serogroup B, the bacteria responsible for menB.

Pfizer – which is in the midst of a large-scale phase III programme for rLP2086 that kicked off in November 2012 – filed a marketing application for its vaccine in the US in June, on the same day that Novartis submitted Bexsero to the FDA.

Both vaccines have also been awarded breakthrough status by the US regulatory authority, setting up a head-to-head review and placing them on track to reach the market by early 2015 and possibly earlier.

The majority of invasive meningococcal disease cases worldwide can be attributed to five Neisseria meningitidis serogroups (A, B, C, W and Y), but menB accounts for around 40% of all cases in the US, according to Pfizer.

In the UK, around 90% of all cases of meningococcal disease in the UK are now caused by group B meningococcal bacteria since the introduction of a vaccine for menC in the late 1990s resulted in a dramatic reduction in the number of people exposed to that form of the infection.

Novartis will shortly be handing Bexsero over to GlaxoSmithKline (GSK) as part of an asset swap deal agreed earlier this year.

Phil Taylor
9th October 2014
From: Research
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