The Daily Telegraph

Vernalis shares off colour after US medicine setback

- By Iain Withers

BRITISH biotech group Vernalis has been hit by a setback for one of its key cough and cold treatments, sending the Aim-listed firm’s shares down 16pc.

Vernalis told investors – which include fund manager Neil Woodford and Invesco – it had received a socalled complete response letter (CRL) from US agency the Food and Drug Administra­tion for its product CCP-08. It means the medicines regulator is not prepared to approve it at this time. Vernalis received a similar CRL for cold remedy CCP-07 in April.

Ian Garland, chief executive of Vernalis, confirmed both products had encountere­d similar difficulti­es, but said they remained “of the utmost importance” to the company. “Unfortunat­ely, the outstandin­g items that resulted in a CRL for CCP-07 could not be addressed in time to avoid the same outcome for CCP-08,” he said.

He added Vernalis was working with manufactur­ing partner Tris to iron out the issues and would resubmit both applicatio­ns “as quickly as possible”.

Julie Simmonds, an analyst at Panmure, said that she had “no expectatio­n of sales from either product in the 201718 flu season”.

Shares fell 10.5pc to 17p yesterday 16pc to 16p. They have dived more than 80pc since their 2015 peak of 86.5p.

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