February 16, 2009 / 8:46 AM / 10 years ago

UPDATE 2-Ark's Cerepro drug gets "named patient" approval

* First time drug used outside clinical trial

* Was requested by French authorities

* May mean other agencies make similar requests

* Shares rise 8 percent (Adds share price, analyst reaction)

LONDON, Feb 16 (Reuters) - Gene medicine company Ark Therapeutics AKT.L said on Monday its lead drug Cerepro had been made available to a patient outside a clinical trial for the first time, sending its shares up 8 percent.

Authorities in France had requested that the brain cancer drug be made available on a so-called named patient basis, the company said.

At 0821 GMT Ark shares were up 8 percent at 47.5 pence.

The development is significant because Cerepro is a new type of gene medicine with a novel mode of action, and authorities are typically cautious when approving such medicines for use in patients.

Analysts believe that the approval could mean that the drug is made available in other territories.

“This approval may trigger other regulatory agencies, under pressure from physicians, to approve the product under the same route,” analysts at Piper Jaffray said in a note to clients.

However, KBC’s Paul Cuddon in a note cautioned that he was keeping his “sell” rating on the company until the Phase III survival data for Cerepro was made available. (Reporting by Ben Deighton, editing by Will Waterman)

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