Pfizer Inc.’s pneumonia vaccine met the goals of a study that was required by U.S. regulators when the therapy was approved for patients at least 50 years old.
The clinical trial called Capita showed the vaccine worked against a first episode of vaccine-type community-acquired pneumonia in patients 65 and older, Pfizer said today in a statement. The Food and Drug Administration approved Prevnar 13 for adults 50 and older in December 2011 on an accelerated basis with the condition the New York company prove the shot protects against pneumonia in post-clearance studies.
The vaccine is expected to generate $4.4 billion in revenue this year, according to the average of three analysts’ estimates compiled by Bloomberg. Prevnar 13 competes with Merck & Co.’s Pneumovax 23, approved about 30 years ago.
The vaccine’s use in adults is expected to contribute $1 billion to sales, Mark Schoenebaum, an analyst with ISI Group, said in a note today.
Pfizer rose 1.7 percent to $31.99 at the close in New York. The company has gained 17 percent in the past 12 months.
The FDA approval was based on studies that showed patients taking Prevnar 13 had comparable or higher antibody levels than those taking Pneumovax 23. The results indicated the vaccine was reasonably likely to produce clinical benefit, which is what Pfizer sought to prove in the Capita trial.
Pfizer plans to share detailed results from the trial at a conference in India on March 12, according to the statement.
Prevnar 13 was approved in the U.S. in 2010 for children 6 weeks to 5 years old.