Vernalis hit by fresh U.S. setback for cough and cold drug

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Vernalis hit by fresh U.S. setback for cough and cold drug

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LONDON (Reuters) – Shares in Vernalis <VER.L> fell 5.3 percent on Monday as the British biotech company backed by fund manager Neil Woodford and his previous employer Invesco announced a fresh setback for a key new drug in the United States. The company said its cough and cold treatment CCP-08 had received a so-called complete response letter (CRL) from the Food and Drug Administration (FDA), meaning the agency is not prepared to approve it at this time. The blow follows a similar CRL for the company’s sister product CCP-07 in April. “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,” Chief Executive Ian Garland said. Garland added that both drugs were “of the utmost importance to Vernalis” and the company was working with its partner Tris and the FDA to resubmit both applications as quickly as possible. It expects to provide an update on progress “in the coming months”.

(Reporting by Ben Hirschler; editing by Jason Neely)
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