Shire dry eye drug has mixed results in pivotal trial

LONDON Fri Dec 6, 2013 2:46am EST

LONDON Dec 6 (Reuters) - British drugmaker Shire, whose shares have performed strongly this year, reported mixed results with a key new drug for dry eye disease on Friday, leaving the future of the product unclear.

Lifitegrast did reduce patient-reported symptoms of dryness in a late-stage trial - the first drug to do so in a Phase III setting - but it missed a second target that measured signs of the disease based on corneal staining.

The findings from the latest trial contrast with those of an earlier Phase III one that found an improvement in disease signs, but not in symptoms.

Lifitegrast - a potential competitor for Allergan's Restasis - is viewed as a key new product for Shire as it seeks to diversify its product line-up.

Shire Chief Executive Flemming Ornskov said the company would now examine the totality of the data across the clinical trials and discuss the future of the lifitegrast programme with regulatory authorities.

Shire obtained lifitegrast after buying U.S. biotech firm SARcode Bioscience for an initial $160 million in March, marking a sizeable bet on the ophthalmology space by Britain's third biggest drugmaker.

Shire has been hoping to launch lifitegrast in the United States as early as 2016.

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