By Bill Berkrot
Dec 12 (Reuters) - Pfizer Inc will pay $55 million plus
interest to settle charges that Wyeth promoted its acid reflux
drug Protonix for unapproved uses and made unproven claims about
the medicine, the U.S. Department of Justice said on Wednesday.
The infractions took place between February 2000 and June
2001, long before the world's largest drugmaker acquired Wyeth
in 2009 for $68 billion. Protonix, which belongs to a class of
widely used medicines called proton pump inhibitors (PPI), has
since gone off patent and is available in cheap generic versions
as pantoprazole.
Protonix was approved by the U.S. Food and Drug
Administration for short-term treatment of erosive esophagitis
-a condition related to gastro-esophageal reflux disease, or
GERD, that can only be diagnosed via endoscopy.
The Justice Department accused Wyeth of training its sales
force to promote Protonix for all forms of GERD, which is far
more common and likely to lead to significantly higher sales.
"Wyeth tried to cheat the system by obtaining a limited FDA
approval for Protonix, fully intending to promote this drug for
additional, unapproved uses," U.S. Attorney Carmen Ortiz said in
a statement.
In addition, Wyeth allegedly promoted Protonix as the "best
PPI for nighttime heartburn" even though there was never any
clinical evidence that it was more effective than any other PPI,
such as AstraZeneca's Nexium, for that use, the Justice
Department said.
Pfizer issued a statement saying that it was not the target
or subject of this case, but felt that settling it was in its
best interest.
"Resolving this investigation regarding Wyeth's historical
promotional practices of Protonix is the right thing to do," the
company said. "In settling, we avoid both the cost and
distraction of litigation and we expressly deny the allegations
of wrongdoing."
Pfizer shares were down 14 cents at $25.50 in midday trading
on the New York Stock Exchange.
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