fizer has been boosted by the news that advisors to the US regulator have recommended approval of a new version of the blockbuster childhood vaccine Prevnar, acquired through the recently-completed merger with Wyeth.
The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted 10 to one that the data presented support the safety and effectiveness of Prevnar 13 for the prevention of invasive pneumococcal disease in infants and young children. Specifically, the company is seeking an indication for active immunisation for the prevention of invasive disease (including sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema) and otitis media (middle ear infections) caused by 13 Streptococcus pneumoniae serotypes.
The committee reviewed data from 13 Phase III studies involving more than 7,000 children and agreed that Prevnar 13’s safety profile was “adequate to support its safety”, Pfizer noted. However, a number of advisers reportedly expressed concern over data from trials showing that the new vaccine had not proved more effective than original Prevnar in certain strains, and some panelists want to see more data concerning its effectiveness to treat otitis media.
Prevnar, launched in 2000, has been a major earner for Wyeth and last year brought in $2.7 billion. The latest version received a positive opinion in late September from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The vaccine is also being studied in Phase III trials for the prevention of pneumococcal disease in adults, with regulatory submissions expected in 2010.
Neglected diseases pact
Pfizer also noted that it has signed a deal with the not-for-profit Drugs for Neglected Diseases initiative which will see the latter screen at least 150,000 compounds in the New York-based behemoth’s library against parasites to see if they are effective against African sleeping sickness, visceral leishmaniasis and Chagas disease. Sam Azoulay, senior vice president of medical & development at Pfizer’s emerging markets business unit, said the “significant resources and expertise that public-private partnerships such as this one…will accelerate and significantly increase the chances of success in the search for effective new drugs against serious infections that disproportionately affect the poor”.