SmithKline Diabetes Pill May Get FDA Action Tomorrow [Tuesday]
Bloomberg News
May 24, 1999, 4:34 p.m. ET
SmithKline Diabetes Pill May Get FDA Action Tomorrow (Update1)
(Adds closing share price)
Washington, May 24 (Bloomberg) -- SmithKline Beecham Plc's
Avandia pill for type-2 diabetes, a competitor to Warner-Lambert
Co.'s Rezulin, could win approval from the U.S. Food and Drug
Administration by tomorrow.
The FDA must act on the Avandia new-drug application by
tomorrow or face a financial penalty, according to agency
guidelines. Analysts expect the agency to accept the advice of an
expert FDA panel, which recommended approval of the drug last
month.
Avandia and Takeda Chemical Industries Ltd.'s still-
unapproved Actos are expected to overtake Rezulin, which has been
linked to cases of liver failure and death. Analysts said the two
new drugs could each achieve sales of more than $1 billion a year
in what could become a $5-billion-a-year market for diabetes
drugs.
Though the FDA is expected to require that Avandia and Actos
carry some of the same precautions that Rezulin does, analysts
said the new drugs appear to be safer than Rezulin, which had
$748 million in sales in 1998.
SmithKline, Europe's fifth-biggest drugmaker, is looking to
Avandia to bolster growth as sales for older drugs begin to
decline.
''SmithKline is looking for new products, and Avandia could
be a big one,'' said Alex Zisson, an analyst with Hambrecht &
Quist, after a panel of advisers recommended the drug for
approval.
Avandia is a treatment for type-2, or adult-onset, diabetes,
a form of the disease that affects more than 14 million
Americans.
SmithKline's American depositary receipts fell 2 3/16 to 61
3/16.
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