* Lifitegrast hits one goal in trial, misses second
* Mixed clinical data leaves path to market unclear
* Shares down 2.2 percent
By Ben Hirschler
LONDON, Dec 6 British drugmaker Shire,
whose shares have stormed ahead this year, disappointed
investors on Friday with clinical trial results of a new dry eye
drug that left the product's future unclear.
Lifitegrast did reduce patient-reported symptoms of eye
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.
Shares Britain's third biggest drugmaker fell 2.2 percent by
0820 GMT on the news.
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, which is expected to have sales of around $900 million
this year - 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 lifitegrast with regulatory
authorities, such as the U.S. Food and Drug Administration
Analysts, however, were sceptical about the drug's future.
"Given these equivocal results and FDA's typical need for
two supportive trials, we see an uncertain approval path,"
Jefferies analysts said in a note.
"Our modest $400 million peak (sales forecast) at 50 percent
probability already fairly reflects this, but we see risk to
others' more optimistic estimates."
Shire obtained lifitegrast after buying U.S. biotech firm
SARcode Bioscience for $160 million upfront in March - plus
undisclosed payments upon achievement of certain drug
development and commercial milestones - marking a sizeable bet
on the ophthalmology space by the group.
Shire has been hoping to launch lifitegrast in the United
States as early as 2016.