To: Bull-like who wrote (350 ) 10/7/1998 10:43:00 AM From: Anthony Wong Read Replies (1) | Respond to of 642
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