Drug Development

Shire gains a delayed FDA OK for ‘blockbuster’ dry eye drug lifitegrast

Nine months after the FDA handed Shire $SHPG a rejection for its dry eye drug lifitegrast, the biotech company says it’s bounced back with a delayed approval from the FDA. And now Shire will set out to see if it can achieve its earlier forecast of more than a billion dollars in annual sales.

Shire will be tackling a broad market including more than 16 million people who have been diagnosed with dry eye disease. The company plans to get started marketing the eye drop therapy in a few months, selling it as Xiidra.

Flemming Ornskov, CEO of Shire

Flemming Ornskov, CEO of Shire

The approval marks a clear win for CEO Flemming Ornskov, who brought a desire to develop a pipeline of new ophthalmic drugs when he took the helm at Shire, based in Dublin with an R&D heart centered in Lexington, MA. And the market loved the news, sending Shire share up 5%.

Ornskov made lifitegrast a key part of his plan to grow sales to $10 billion a year, ahead of his big acquisition of Baxalta. And he’s had some ups and downs along the way.

This approval, though, marks a signal step ahead for the company, if the drug performs on the market. Once the subject of an AbbVie takeover attempt, which was scuttled by new federal rules designed to derail tax inversions, Ornskov has remained committed to making Shire into a global biopharma force to be reckoned with.

In this case, Shire will have to contend with Brent Saunders and Allergan, which earned more than a billion dollars last year for the leading dry eye treatment on the market, Restasis (cyclosporin). The bulk of that money came from the big U.S. market.

“As Shire’s first FDA-approved medicine in ophthalmics, this significant milestone advances our goal of becoming the global leader in this category, where there are unmet patient needs,” Ornskov said in a statement. “We have a robust ophthalmics pipeline, and we look forward to leveraging Xiidra as our entrée into the space as we continue to develop additional innovative eye care treatment options.”


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RAPS Regulatory Convergence 2017