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

Written by: | no-reply@reuters.com | Dated: Tuesday, October 27th, 2015

London-listed pharma firm Shire 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. regulators early next year.

Shares in Shire jumped more than 6 percent after it announced the positive results of the study on Tuesday. They were trading up 5 percent at 4,838 pence at 1305 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 at least $1 billion a year by 2020, in the first quarter, and if approved it could be launched later in 2016.

“We have a very attractive package to refile with the FDA,” he told Reuters on Tuesday.

The randomized study had delivered “pretty amazing data” that showed the product worked within 14 days, he said, and if approved, it would make available a new class of drug to treat a condition that affected about 29 million Americans.

A submission in Europe would follow, he said, and the company was also looking at the Canadian and Japanese markets.

Analysts at Jefferies said the new study – the fifth in total for the medicine – would boost the likelihood of approval, a development which justified around a 5 percent uptick in the stock price.

They said the FDA had indicated that the only other prescription drug on the market for the condition – Restasis – had only marginal efficacy, setting a relatively low bar for approval.

The news on the drug – the most significant in Shire’s push into ophthalmic medicine – would help Shire’s attempt to buy U.S. rare disease peer Baxalta, Ornskov said.

The appeal of Shire’s all-share proposal has been tarnished by an around 24 percent drop in the value of its paper since it revealed its interest in striking a $30 billion deal in August.

Shire’s stock has been hit by uncertainty over the Baxalta bid and a wider rout in drug company shares driven by investor worries about political pressure on U.S. drug prices.

“Today the equity story for Shire has been strengthened and what could have been seen as potential large uncertainty on the part of Baxalta shareholders must have been somewhat diminished today with this data,” Ornskov said.

 

(Editing by Sarah Young and Adrian Croft)

Source: Reuters Health

http://www.reuters.com/article/2015/10/27/us-shire-fda-new-study-idUSKCN0SL1I120151027

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