Bristol-Myers Halts Lobucavir Trial on Safety Concern (Update1)
Bloomberg News
February 10, 1999, 12:10 p.m. ET
Bristol-Myers Halts Lobucavir Trial on Safety Concern (Update1)
(Adds analyst comment, updates share activity.)
New York, Feb. 10 (Bloomberg) -- Bristol-Myers Squibb Co.,
the second-biggest U.S. drugmaker, said it halted tests of a
hepatitis-and-herpes drug after studies in rats revealed a tumor
risk, the company's second drug-discovery setback in two days.
Bristol-Myers said it has halted tests of the drug
lobucavir, which was in the last of three stages of testing
required to apply for U.S. approval. Yesterday, the company said
it ended an agreement to develop a much-publicized EntreMed Inc.
experimental cancer drug.
The back-to-back disappointments show the high odds
drugmakers face in bringing new medicines to the market. Earlier
this year, Merck & Co. dropped research into a compound as a
potential blockbuster depression drug.
''The chances are always better for a compound to fail than
for it to succeed,'' said Cynthia Beach, an analyst with Gerard
Klauer Mattison & Co. ''Still, the timing isn't good'' for
Bristol.
The company said rats that were given the drug as part of
''lifetime'' safety studies appear to have a higher rate of
tumors which may be drug-related.
The company halted its studies of the drug to examine all
the data, and said that there has been no link to any increased
tumors in humans. Animal findings often vary from the effects a
drug has on humans, but are an important tool in evaluating
safety and efficacy.
Sales of lobucavir could have been about $200 million by
2002, according to an SG Cowen estimate last month.
Shares in Bristol-Myers fell 3/4 to 121 3/4 in midday
trading.
Lobucavir, designed to treat chronic hepatitis B and herpes,
has been given to about 5,000 patients worldwide -- most of whom
took the drug for five days or less, the company said.
The company had reached the third of three stages of
development required for marketing clearance by the U.S. Food and
Drug Administration.
--Kristin Reed in Washington (202) 624-1858 with reporting by
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