Lilly Says FDA Rejects New Use of Schizophrenia Drug (Update1)
Bloomberg News
October 7, 1998, 10:15 a.m. ET
Lilly Says FDA Rejects New Use of Schizophrenia Drug (Update1)
(Adds stock price in 5th paragraph.)
Washington, Oct. 7 (Bloomberg) -- Eli Lilly & Co., maker of
the top-selling depression drug Prozac, said the U.S. Food and
Drug Administration won't approve a new use for its schizophrenia
drug Zyprexa at this time.
The FDA sent the Indianapolis-based drugmaker a so-called
non-approvable letter for the new indication. Lilly, the world's
10th biggest drugmaker, was seeking FDA approval to sell the
drug, already in wide use for treating schizophrenia, for
expanded use in treating bipolar disorder, or manic depression.
The company said it's already conducting additional studies
that could help it win FDA approval of the new use.
''While we are disappointed with the FDA's decision, we
remain committed not only to treating the disease state of
bipolar disorder, but also looking at additional clinical
benefits of Zyprexa,' said August Watanabe, executive vice
president for science and technology at Lilly, in a statement.
Lilly fell 2 1/2 to 75 in early trading. Zyprexa has
been one of Lilly's top growth products, bringing in $327.9
million in the second quarter. It competes against drugs such as
New Brunswick, New Jersey-based Johnson & Johnson's Risperdal in
the schizophrenia market.
The FDA's ruling on the new application won't affect the
drug's use in schizophrenia, Lilly said.
''The bipolar market is big, but Zyprexa is still growing
fast enough for schizophrenia,'' said Alex Zisson, an analyst
with Hambrecht & Quist who has a ''neutral'' rating on Lilly.
Zyprexa had $730 million in 1997 sales, its first full year
on the market. It could have 1998 sales of $1.4 billion, Zisson
said.
--Kristin Jensen in Washington (202) 624-1843 and Kerry Dooley in |
