UPDATE 1-NicOx says key drug rejected by FDA

* FDA has not approved application for Naproxcinod -NicOx

* Recommends further trials on the drug

* NicOx to hold talks with FDA as soon as possible
(Adds detail from statement)

PARIS, July 22 (BestGrowthStock) – The U.S. Food and Drug
Administration has rejected NicOx’s (NCOX.PA: ) pain drug
Naproxcinod, recommending further trials, the French
biotechnology group said on Thursday.

NicOx, which has spent about 10 years and 100 million euros
($127.6 million) to fund the U.S. launch of its lead
anti-inflammatory drug, said it would hold talks with the FDA as
soon as possible to discuss potential next steps.

Citing a response letter, NicOx said the FDA had recommended
conducting more long-term controlled studies to assess the
safety of Naproxcinod on a cardiovascular and gastrointestinal
level.

An FDA advisory panel had already voted against approving
the drug in May, sending NicOx shares to a four-year low.
[ID:nLDE64C05Z]

NicOx Chief Executive Michele Garufi told Reuters last month
he remained hopeful for the drug, even as some analysts
questioned the group’s drug development technology.
[ID:nLDE65F295]

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(Reporting by Lionel Laurent and James Regan; Editing by David
Holmes)
($1=.7836 Euro)

UPDATE 1-NicOx says key drug rejected by FDA