* Wyeth says vaccine protects against more bacterial forms
* Says on track to seek approval for adults next year
* Glaxo wins European approval of rival product (Adds analyst comment, updates shares)
By Ransdell Pierson
NEW YORK, March 31 (Reuters) - Wyeth said (WYE.N) on Tuesday it had asked U.S. regulators to approve a more-protective form of Prevnar, its blockbuster pneumococcal vaccine to prevent infections among infants and children.
The experimental product, called Prevnar 13, is designed to protect against 13 serotypes, or forms, of a bacterium called streptococcus pneumoniae (pneumococcus) that can cause an array of diseases, ranging from ear infections to pneumonia and meningitis.
Prevnar, which was introduced in 2000 and had 2008 sales of $2.7 billion, currently protects against seven serotypes that account for about 80 percent of potential infections. Wyeth has said the new product, now awaiting approval in Europe, could broaden protection against perhaps 92 percent of potential infections in infants and toddlers.
Wyeth, slated to be acquired later this year by Pfizer Inc (PFE.N), on Tuesday reaffirmed it expects to seek regulatory approvals in 2010 to market Prevnar 13 to adults.
Herman Saftlas, an analyst with Standard and Poor's, said the improved form of the vaccine could eventually boost annual sales of the Prevnar franchise to $4 billion.
"This drug could move Pfizer much more aggressively into the vaccine area, and once they muscle in, they do things in a big way," Saftlas said.
Even as Wyeth sought U.S. approval for Prevnar 13, a rival vaccine sold by GlaxoSmithKline Plc (GSK.L) (GSK.N) was cleared by European regulators.
But Glaxo CEO Andrew Witty in February said Glaxo was unlikely to seek U.S. approval for its product, called Synflorix, which is active against 10 types of streptococcus pneumoniae.
Prevnar is not currently approved to protect adults, but sales of Prevnar 13 for that population segment could eventually top $1.5 billion, Wyeth has said.
Pneumonia caused by the pneumococcal organism is one of the biggest causes of death in older individuals and its incidence begins to increase when one is about 50 years old, and increases rapidly thereafter as the immune system weakens.
The mortality rate for adults with that form of pneumonia averages 10 percent to 20 percent even in developed countries, according to Wyeth, and can exceed 50 percent in high-risk patients.
Prevnar is Wyeth's second-biggest selling product, and is still among the company's fastest-growing products due to continuing launches around the world.
Glaxo's shares rose 4 percent in afternoon activity on the New York Stock Exchange, while shares of Wyeth and Pfizer were little changed. (Editing by Gunna Dickson and Maureen Bavdek)
No comments:
Post a Comment