pays $460 million to resolve Avandia suits
was facing more than 13,000 claims alleging that it hid the diabetes drug's
P.L.C. agreed to pay about $460 million to resolve a majority of lawsuits
alleging that the company's Avandia diabetes drug can cause heart attacks
and strokes, people familiar with the accords said.
the British pharmaceutical company that has major operations in the Philadelphia
area, agreed to settle about 10,000 suits for an average of at least $46,000
apiece, the people said.
company had been facing more than 13,000 suits alleging that Glaxo hid the
drug's heart-attack risk, according to UBS AG analyst Gbola Amusa. The settlements
come as Glaxo is set to face its first Avandia trial in federal court in
Philadelphia in October.
is exceptionally good news, given the market has discounted $6 billion in
liability" for Avandia litigation, Amusa said. "We had outlined
an absolute worst-case scenario where $500,000 per case would have to be
paid." At that amount for 13,000 cases, the total would have been $6.5
is settling Avandia claims as a U.S. Food and Drug Administration advisory
panel met Tuesday to consider whether Avandia's ability to control blood-sugar
levels outweighs a possible increase in heart attacks, strokes, and deaths
from cardiovascular disease.
panel is to conclude its two-day session Wednesday. The FDA is asking the
group to untangle the mess of data that has stumped its own scientists for
more than three years.
advisers will vote on recommendations to the agency, including possible
withdrawal of the drug from the market. The FDA will make a final decision
in coming months.
a similar group of experts voted to keep Avandia on the market despite an
analysis of dozens of studies suggesting it increased the risk of heart
attack. The agency is not required to follow the group's advice, though
it often does.
Commissioner Margaret Hamburg opened the meeting by advising panelists to
"follow the science wherever it leads and the rest will fall into place."
it became clear that the FDA's own staff have reached vastly different conclusions
from the same science.
Anne Rhyne, a Glaxo spokeswoman, declined to comment about a settlement.
American depositary receipts rose 1.7 percent, or 60 cents, to $35.72 on
the New York Stock Exchange.
generated $1.1 billion in sales last year for Glaxo, only about a third
of the revenue it had before researchers linked the medicine in 2007 to
a 43 percent increased risk of heart attacks. Avandia was once the world's
best-selling diabetes pill, generating $3 billion in annual revenue.
FDA official, Dr. Rosemary Johann-Liang, said Glaxo withheld from regulators
a study showing Avandia may cause heart attacks, according to two people
familiar with her deposition in a suit against the drugmaker.
disputes Johann-Liang's contentions that it didn't turn over a 2001 review
of Avandia's health risks to federal regulators, Rhyne, the company spokeswoman,
said last week in an e-mailed statement.
Feeley and Trista Kelley - Bloomberg News
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