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 The 85,000-patient study, called CAPiTA, also showed
that Prevnar 13 prevented invasive pneumococcal disease, meaning
infections of Streptococcus pneumonia bacteria in the bloodstream
and other normally sterile sites in the body.
Wall Street analysts have predicted that success of the trial would
boost annual sales of Prevnar 13 by $1 billion or more, as doctors
steer elderly patients to the product.
"We expect the U.S. and other developed markets to broadly recommend
adult use of the product," given favorable results from the study,
J.P. Morgan analyst Chris Schott said in a research note.
Schott said he expects Prevnar 13 sales among adults of $300 million
in 2015, rising to $1.5 billion in future years as it is more widely
used for that population.
An estimated 300,000 adults aged 50 and older are hospitalized every
year because of pneumococcal pneumonia, a substantial cause of
illness and death, according to the U.S. Food and Drug
Administration.
Prevnar 13, sold under the brand name Prevenar 13 in many markets
outside the United States, is one of Pfizer's biggest products. The
drug, and an older version of the vaccine known as Prevnar 7, have
annual sales of $4.4 billion, making them the company's
second-biggest franchise.
During the trial, Prevnar 13 met its primary goal of preventing a
first episode of community-acquired pneumonia. It also met a
secondary goal of preventing a first episode of invasive bloodstream
infections, which are typically far more severe than pneumonia
without such bloodstream involvement.
Pfizer said data from the study, conducted in the Netherlands, would
be presented at a medical meeting in India next month.
The FDA in early 2010 approved Prevnar 13, to protect children
against additional strains of Streptococcus pneumoniae bacteria that
cause an array of diseases, including pneumonia, ear infections and
meningitis.
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But the U.S. health regulator in late 2011 widened the approved
use of Prevnar 13 to include adults age 50 and older, to prevent
pneumonia and invasive infections. The approval was conditioned,
however, on success of the now-completed CAPiTA study.
Favorable data from the study are expected to be added to the
package insert label of Prevnar 13, greatly boosting the
attractiveness of the vaccine to doctors with elderly patients.
Tim Anderson, an analyst with Sanford Bernstein & Co, said
relatively few adults have yet been vaccinated with Prevnar 13. He
predicted adult sales will rise to $1.3 billion in 2020 and that
total sales of the Prevnar franchise will rise to $6 billion that
year.
Pfizer shares rose 1.2 percent to $31.85 in morning trading on the
New York Stock Exchange, amid a 0.7 percent gain for the ARCA
Pharmaceutical Index of large U.S. and European drugmakers.
(Reporting by Ransdell Pierson and
Caroline Humer; editing by Jeffrey Benkoe, Bernadette Baum and
Jonathan Oatis)
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