Takeda, Lilly Diabetes Drug Gets Faster Review at FDA (Correct)
Bloomberg News
March 12, 1999, 4:53 p.m. ET
Takeda, Lilly Diabetes Drug Gets Faster Review at FDA (Correct)
(Corrects spelling of Davis' name, adds closing shares.)
Princeton, New Jersey, March 12 (Bloomberg) -- Takeda
Chemical Industries, Japan's largest drugmaker, said U.S.
regulators will speed their review of the company's Actos
diabetes pill, which could become a rival to Warner-Lambert Co.'s
blockbuster Rezulin diabetes drug.
The U.S. Food and Drug Administration decision to give so-
called priority status to Actos -- which Eli Lilly & Co. will
help promote in the U.S. -- means agency officials hope to review
the drug in six months rather than one year. In winning the quick
evaluation, Actos enters a race to market with SmithKline Beecham
Plc's diabetes drug, Avandia, also under priority review.
Both drugs could be a safer alternative to Rezulin, which
the FDA is reviewing after the Warner-Lambert drug was linked to
liver damage and more than 30 deaths.
''It's definitely a race to the finish as far as who is
going to get there first'' and win FDA approval, said Corey
Davis, an analyst with Hambrecht & Quist. ''Good news on one or
the other will definitely affect the competition.''
Shares in Lilly rose 2 1/16 to close at 94 15/16, while
American depositary receipts in SmithKline fell 1 11/16 to 70 5/8
and Warner-Lambert shares rose 3/16 to 72 5/16.
Rezulin's risks may lead regulators to welcome drugs with
fewer side effects, and investors are already expecting
challengers, analysts said.
Safety Review
Shares in Warner-Lambert fell about 6 percent after the FDA
said it would hold a panel meeting March 26 to review the safety
of the drug. The same panel will weigh new drug applications for
Avandia and Actos April 22 and 23.
''Warner-Lambert's stock will continue to be timid until the
hearing,'' Davis said. ''A positive outcome for Warner-Lambert
would definitely be good news for the stock, with some
limitations because of the obvious competition threats from Actos
and Avandia.''
Rezulin, introduced in 1997, had sales of $748 million last
year. Analysts have estimated that sales of Avandia could exceed
$1 billion within a few years of its introduction, if it proves
safer than Warner-Lambert's drug.
As the U.S. population ages, more people will develop the
Type 2 that Rezulin, Actos and Avandia are aimed at treating.
In this form of diabetes, the body does not produce enough
of the hormone insulin to keep blood-sugar levels under control.
Rezulin works by helping the body make better use of its own
insulin and keep blood-sugar levels in check. Uncontrolled
diabetes can lead to death and severe complications, such as
amputations, stroke and blindness.
With growing need for these diabetes drugs, the FDA was
expected to grant a priority review to Actos, especially after
announcing earlier this month that there would be an April panel
meeting, Beach said.
Race to Market
The back-to-back reviews of the SmithKline and the Takeda
pills could mean that Actos might reach the U.S. market faster
than expected, Beach said.
''It tells us Actos could be approved quicker than the usual
six months,'' said Cynthia Beach, an analyst with Gerard Klauer
Mattison, who has ''buy'' ratings on SmithKline and Lilly and a
''hold'' on Warner-Lambert.
''Actos and Avandia, they're both bad news for Rezulin,''
Beach said.
SmithKline and Takeda could both begin sales of their drugs
as early as this year. In choosing Lilly as its U.S. marketing
partner, Takeda tapped one of the world's largest sellers of
diabetes medicines. Lilly sold $1.15 billion in insulin products
in 1998, making it one of the world's top sellers of diabetes
drugs. Lilly pioneered development of insulin as a drug and began
sales of it in the 1920s.
--Brian Reid in Washington (202) 624-1936, Kerry Dooley in |
