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Shire to resubmit dry-eye disease drug to FDA with new study data

Reuters - UK Focus

LONDON, Oct (HKSE: 3366-OL.HK - news) 27 (Reuters) - London-listed pharma firm Shire (Amsterdam: QB8.AS - news) said its dry-eye disease drug lifitegrast significantly improved patient symptoms in a new study, supporting a re-submission of the potentially block-busting medicine to U.S (Other OTC: UBGXF - news) . regulators early next year.

Shares (Berlin: DI6.BE - news) in Shire (Xetra: S7E.DE - news) jumped more than 6 percent after it announced the positive results from the study on Tuesday. They were trading up 5.1 percent at 4,845 pence at 1154 GMT.

The U.S. Food and Drug Administration declined to approve lifitegrast earlier this month, saying it wanted more data from an additional clinical study.

Shire's Chief Executive Flemming Ornskov said the company would resubmit the drug, which it has said could have sales of $1 billion by 2020, in the first quarter of next year, and if approved it could be launched later in the same year. (Reporting by Paul Sandle; editing by Sarah Young)