* Prevnar 13 was key product acquired from Wyeth
* Vaccine advisers recommend new shot
* Pfizer shares gain 0.8 percent
(Recasts; Adds details on price, analyst comment, closing
By Lisa Richwine
WASHINGTON, Feb 24 Pfizer Inc's (PFE.N) new
version of a blockbuster vaccine that fights pneumonia,
meningitis and other infections won approval from U.S. health
officials on Wednesday.
Government vaccine advisers recommended the new Prevnar 13
shot for infants who have not been immunized with the original.
They also urged one dose for children up to age 5 who already
received all four doses of the earlier vaccine.
Prevnar 13 was the most important experimental product
Pfizer acquired in last year's purchase of Wyeth. It fights 13
strains of Streptococcus pneumoniae bacteria, or pneumococcus.
The original Prevnar, which targeted seven strains, was
introduced in 2000 and has annual sales around $3 billion.
Infections caused by pneumococcus greatly declined after
the original Prevnar was launched. At the time, the seven
targeted strains accounted for 80 percent of invasive
pneumococcal infections in young children in North America.
By 2007, cases had dropped 99 percent in children younger
than 5 years old, according to the Food and Drug Administration
Studies also showed disease rates fell in unvaccinated
people, especially the elderly.
"Although the rates of invasive pneumococcal disease have
declined dramatically, there are still children in the United
States who are suffering with this serious illness," Dr. Karen
Midthun, acting head of the FDA's unit that reviewed Prevnar
13, said in a statement.
The new version "will help prevent pneumococcal disease
caused by" the six additional strains, she said.
Pfizer has estimated that the added protection could reduce
deaths from pneumococcus by an extra 9,800 over 10 years.
The new vaccine targets a strain called 19A that has
emerged as the most common cause of pneumococcal infection in
the United States. That strain is becoming harder to treat as
it develops resistance to antibiotics, said Dr. Emilio Emini,
Pfizer's chief scientific officer for vaccine research.
Deutsche Bank analyst Barbara Ryan said approval of Prevnar
13 "was expected, and is an incremental opportunity for the
current $3 billion Prevnar franchise."
She said sales of the vaccine could grow to $4.5 billion a
year if Prevnar 13 is approved for adults. Pfizer hopes to
apply for approval for adult use by year's end, Emini said.
Pneumonia caused by the pneumococcal organism is one of the
biggest causes of death in older people and its incidence
begins to increase after age 50.
The FDA approved the four-dose Prevnar 13 for infants and
children ages 6 weeks through 5 years for preventing invasive
diseases caused by the 13 strains. It also approved the vaccine
for preventing ear infections caused by the original seven
In studies in children, potential side effects were similar
in Prevnar 13 and the original shot and included tenderness at
the injection site and irritability.
Pfizer will charge private providers $108 for Prevnar 13,
company spokeswoman Kristen Neese said.
Leerink Swann analyst Seamus Fernandez said the pricing was
higher than he had expected and reiterated his "outperform"
rating on Pfizer shares.
GlaxoSmithKline Plc (GSK.L) has a rival vaccine called
Synflorix that is active against 10 strains. Synflorix is
approved in Europe and some other markets, but not in the
Merck (MRK.N) also sells the Pneumovax 23 vaccine, which
fights 23 types of pneumococcus and is the only vaccine of its
type that is FDA-approved for adults.
Pfizer's shares rose 0.8 percent to close at $17.81 on the
New York Stock Exchange.
(Reporting by Lisa Richwine, Maggie Fox and Ransdell Pierson,
editing by Gerald E. McCormick, Toni Reinhold and Carol