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Roche Pulls Accutane Off Market
After Jury Verdicts
Bloomberg, June 26, 2009
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to Original Press Artricle
June 26 (Bloomberg) -- Roche Holding AG,
the world’s biggest maker of cancer drugs, is
pulling its Accutane acne medicine from the U.S. market
after juries awarded at least $33 million in damages
to users who blamed the drug for bowel disease.
Roche notified the U.S. Food and Drug
Administration today that it was withdrawing Accutane
after a “reevaluation” of its product lines
showed it faced serious challenges from generic competitors,
company officials said in a statement.
“In addition, Roche has been faced
with high costs from personal-injury lawsuits that the
company continues to defend vigorously,” according
to the statement.
About 13 million people have taken Accutane
since it went on the market in 1982. The medication
was Roche’s second-biggest selling drug before
the patent expired in 2002 and rivals started selling
generic versions. Roche’s prescription market
share of the drug is now below 5 percent, the company
said.
In April, Basel, Switzerland-based Roche
announced first- quarter sales rose 7 percent to 11.6
billion Swiss francs ($10.1 billion) from 10.9 billion
francs a year earlier. Roche completed its $46.8 billion
purchase of partner Genentech Inc. in March, gaining
access to cancer drugs such as Avastin and Rituxan.
The company faces as many as 5,000 personal-injury
claims over Accutane, said Michael Hook, a Pensacola,
Florida-based attorney. He won a $10.5 million verdict
against the drugmaker over the medicine in April 2008.
He noted that Roche has lost six cases that have gone
to trial over the drug.
“We’ve been winning the cases
with the drug still on the market, but this move certainly
isn’t going to hurt us going forward,” Hook
said in an interview today.
Some Accutane users allege the drugmaker
failed to properly warn them the medicine could cause
inflammatory bowel disease. The drug also has been linked
to birth defects and depression.
Lawyers for John Mullarkey, a 20-year-old
Monroeville, Pennsylvania, man facing murder charges
over the death of his 16-year-old cheerleader girlfriend,
said he was suffering from an Accutane-fueled depression
when the killing occurred, the Pittsburgh Tribune-Review
newspaper reported today.
Shelley Rosenstock, a spokeswoman for
Roche’s Nutley, New Jersey-based U.S. unit, said
in an e-mailed statement that the company doesn’t
break out Accutane sales.
Other Countries
The drug also has been pulled off the
market in 11 other countries including France, Denmark,
Austria, Germany, Portugal, Norway and Spain, Rosenstock
said. She couldn’t provide dates for those withdrawals.
Rosenstock said Accutane’s safety
wasn’t a factor in the decision to yank it off
the U.S. market.
“Roche stands behind the safety
of Accutane and the rigorous risk-management program
Roche developed over decades of cooperation with the
FDA,” she said in the statement.
In November, a state-court jury in New
Jersey found company officials didn’t properly
warn doctors about Accutane’s health risks and
awarded three men a total of $12.9 million in damages.
To contact the reporters on this story:
Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net;
Sophia Pearson in Wilmington, Delaware, at spearson3@bloomberg.net.
Last Updated: June 26, 2009 17:46 EDT
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