Pharmacia Wins FDA Approval for Aromasin Cancer Drug
Peapack, New Jersey, Oct. 22 <A
HREF="aol://4344:30.bloombrg.389091.602536905">(Bloomberg)</A> -- Pharmacia &
Upjohn Inc. said it won U.S. Food and Drug Administration approval for
Aromasin, a new drug to treat advanced cases of breast cancer.
Also today, Pharmacia said it filed applications with the FDA for approval of
its potent new antibiotic, Zyvox, for use in a range of tough infections. The
FDA has agreed to review the drug in six months, rather than the year it
usually takes to approve or reject a drug.
Shares in Pharmacia fell 1 5/16 to close at 51 11/16.
Aromasin tablets were approved for use in treating post- menopausal women
with advanced breast cancer that stops responding to treatment with
tamoxifen. A widely used cancer- suppressing drug, tamoxifen is sold as
Nolvadex by AstraZeneca Plc.
The FDA decision makes Aromasin the second Pharmacia & Upjohn drug in two
months to win approval for treating breast cancer. In September, Pharmacia
won approval for its Ellence breast cancer drug for women in early stages of
the disease.
The application for Zyvox comes earlier than some analysts had expected, and
well ahead of Pharmacia's own goal of filing by the end of the year. The
company, which also makes the antibiotic Vantin, has said it expects to file
for European approval in 1999.
And with a priority review from the FDA, the drug could be approved as early
as April. The drug will likely be used mostly in hospitals and nursing homes,
where the toughest strains of bacteria evolve by infecting older and sicker
patients.
The drug, also called linezolid, is the first in a new class of drugs
designed to be effective against infections which have grown resistant to
most drugs. It likely won't be a blockbuster like antibiotics used for common
infections, such as SmithKline Beecham Plc's Augmentin, which records about
$1.5 billion in annual sales.
Still, Zyvox could have 2003 sales of $275 million, according to SG Cowen
estimates. And along with follow-up and next-generation drugs in the same
class, Zyvox could one day generate sales of $1 billion for Pharmacia,
according to Credit Suisse First Boston Corp. estimates.
Oct/22/1999 17:33
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