Novartis ($NVS) has been wanting to get its meningitis vaccine Bexsero into the U.S. market. Thanks to an outbreak at Princeton University, that's going to happen sooner than the Swiss drugmaker thought. Ahead of FDA approval, in fact.
At the request of the college, the FDA is allowing Novartis to ship Bexsero to the U.S. for a vaccination drive on campus. Bexsero is Novartis' new immunization against meningococcus B, a strain of the bacteria that causes meningitis--a strain that isn't covered by the meningitis-prevention shots already available in the U.S.
And it's the strain implicated in Princeton's outbreak, which began in March. The university has been working with students and parents to curtail the spread of the disease, partly via education efforts, such as email messages reminding students not to share cups. But given the severe nature of the illness--it can be fatal--the university and the U.S. Centers for Disease Control and Prevention (CDC) asked the FDA for access to Bexsero, which is awaiting U.S. approval but is already cleared for sale in Europe and Australia.
The meningococcus B strain causes some 40% of meningitis cases in the U.S. and up to 80% of cases in Australia and some parts of Europe, Bloomberg reports. Though the Princeton outbreak isn't the first caused by the B strain, it's the first since Bexsero became available. "[T]his is the first time we've had an outbreak and also have had the possibility of using a vaccine that could protect against it," CDC spokeswoman Barbara Reynolds told Reuters.
The FDA approved the import request late last week. Over the weekend, Princeton trustees were considering whether to launch a vaccination campaign, spokesman Martin Mbugua told Bloomberg. Novartis says that if Princeton decides to go ahead, the vaccination campaign could begin within a month or two.
Novartis is counting on Bexsero to help boost its lagging vaccines business. Acquired along with Chiron in 2006, the vaccines unit hasn't performed up to the company's expectations--at least not yet. Bexsero could be something of a life ring for that business if it wins over doctors, patients and public-health officials in the U.S. And if Novartis should choose to dispose of the business as part of its company-wide strategic review now underway, solid Bexsero performance could help make the unit more attractive to potential buyers.
Other strains of the disease--A, C, Y, and W-135--are covered by shots currently available in the U.S., including those made by Novartis, Sanofi ($SNY), and GlaxoSmithKline ($GSK). Pfizer ($PFE) is developing its own version of a vaccination against the B strain.
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