"The problem is we don't know exactly which
issues have been raised. We <br>only know it is not a
safety issue, which is good news," said Birgit
<br>Kulhoff at Lombard Odier. <br><br>She said Roche told
analysts it can respond to the issues by "summer," so
<br>the best-case scenario is still for a rollout late
this year and the worst <br>case is the second quarter
of 2002. <br><br>Denise Anderson at Bank Julius Baer
said Roche must have known all along <br>that some
issues were still open or else it would have not have
forecast a <br>fourth-quarter launch for a drug expected
to get FDA approval by May. She <br>stuck to her
forecast the drug would generate 900 million francs in
sales <br>by 2004. <br><br>It is the latest in a series
of late-stage problems for Roche drugs. <br><br>It
halted developing a promising Alzheimer's drug in 1999
when some <br>patients had liver problems during
trials. In 1998 it had to pull heart <br>drug Posicor and
sharply restrict sales of Parkinson's drug Tasmar amid
<br>concerns about side effects. <br><br>"If it's a company
where everything is going along more or less OK, a
<br>well-oiled machine, something like this is frankly part of
doing <br>business," Anderson said. <br><br>"If you
have a company like Roche where this is a vital launch
-- if this <br>launch doesn't go well the company is
totally dead -- then there is a lot <br>of psychological
impact." <br><br>But she said the problem did not put more
pressure on Roche to do a big <br>deal unless the drug
flops when it is launched. <br><br>Kulhoff said the
focus now was on data Roche is set to present in May on
<br>the efficacy of Pegasys in combination with
ribovirin. This is important <br>because Schering-Plough
Corp is already on the market with its monotherapy
<br>pegylated interferon and has already filed combination
data. <br><br>"With this delay Roche has a chance to
get meaningful market share only if <br>the
combination data are good," she said. <br><br>07:25 04-27-01
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