* FDA panel due to discuss ocriplasmin recommendation on
* ThromboGenics remains confident
* Shares reach five-week low
(Adds analyst, company comments, share price)
BRUSSELS, July 24 ThromboGenics' main
drug, the eye treatment ocriplasmin, may have a high rate of
adverse side effects, the U.S. Food and Drug Administration said
in a preliminary report made available on Tuesday.
The report was issued two days before a panel is due to
discuss whether or not to recommend the drug for approval and
sent ThromboGenics shares down as much as 19 percent to a
"There are several adverse events which occur at a much
higher rate in ocriplasmin treated patients which raise concerns
about the drug's potential effect on the retina," the FDA said.
The FDA report added that the side effects may be transient
and cause no long-term harm, but it did not have enough data to
know for sure.
At 1410 GMT, ThromboGenics shares were down 7.6 percent at
However, KBC Securities analyst Jan De Kerpel said he was
not so concerned, adding that the FDA often used harsh language.
"Before drawing the conclusion that we have now here very
negative information in front of us, I need to see more data or
clarification," he said.
ThromboGenics itself said it believed it can demonstrate to
the FDA that the side effects are transient and remained
confident the drug will be approved.
"We have evidence that these things are all transient. There
is nothing that is really sustained. Of course, we will address
this during the discussion," said Chief Financial Officer Chris
"We are well prepared and we are very confident that this
drug will be approved, hopefully after positive advice on
ThromboGenics licensed the eye drug ocriplasmin in March to
Novartis's opthalmic division to sell outside the
United States, but it plans to market the product itself within
the United States.
(Reporting by Ben Deighton; editing by Philip Blenkinsop)