February 25, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Pfizer Inc. was on the rise in early trading Wednesday, after it said a recent Phase II study had shown its Trumenba meningitis B vaccine had met its goal for children ages 10 to 12 and was showing safety and tolerability in a further Phase III trial for patients ages 10 to 25.
The news may help it pull ahead in a race with Novartis AG , which has a similar meningitis B vaccine, Bexsero. That drug is part of a portfolio of vaccines being bought en masse by GlaxoSmithKline and has already received the fast-track approval designation from regulators.
The U.S. Food and Drug Administration (FDA) gave Pfizer accelerated approval for Trumenba in October to be used as an active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25. Pfizer said Wednesday that the recent data was further proof that Trumenba was an increasingly safe and viable option for clinicians looking to combat these diseases.
“These Phase III data add to a growing body of evidence that support TRUMENBA as a well-tolerated vaccine,” said William Gruber, senior vice president of Vaccine Clinical Research and Development for Pfizer Inc. “Further, the results observed in our Phase II study of TRUMENBA co-administered with other routine and recommended adolescent vaccines provide important evidence that we’ve shared with the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices to review as they consider recommendation of meningococcal B vaccination for adolescents and young adults.”
The first study followed 2,600 healthy 10- through 12-year-olds who were gibe Trumenba along with FDA-approved, routine meningococcal (groups A, C, Y and W) (MCV4) and single-dose tetanus, diptheria and pertussis (Tdap) vaccines. The second studied 5,600 healthy patients ages 10 through 25.
In the U.S. meningitis affects around 500 patients under 25 annually, with about 160 cases of meningitis B in 2012. Vaccines have already be developed for the A, C, Y and W strains.
BioSpace Temperature Poll
Analyst Mark Schoenebaum, a biotech and pharmaceuticals analyst and medical doctor for ISI Group Evercore, has been running a Best Hair in Biopharma contest for several months now. So far, the candidates are Bristol-Myers Squibb Company‘s John Elicker, Receptos’ Chief Executive Officer Faheem Hasnain, Celgene‘s Vice President of Investor Relations Patrick Flanigan and Acorda Therapeutics’ Ron Cohen.
We want to know what our BioSpace community thinks: Who do you believe actually has the Best Hair in BioPharma?
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