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Shire files dry eye drug lifitegrast in Europe

Analysts predict Xiidra could become a $1bn product

ShireShire is awaiting the go-ahead of lifitegrast in the EU, seeking approval for the would-be dry eye disease blockbuster.

The Anglo-Irish company claimed approval for first-in-class LFA-1 antagonist lifitegrast under the Xiidra brand name in the US last year at the second attempt, having been knocked back by the FDA in 2015, and launched soon after.

Xiidra was brought to market with a broader label than its main rival - Allergan's Restasis (cyclosporine) - and made $96m in sales in the first half of 2017 with Shire claiming market share of more than 22%. Once fully rolled out, analysts have suggested lifitegrast could become a $1bn product for Shire within the next five years.

The drug still has a long way to go to catch up Restasis, although Allergan reported that sales of its brand slipped 25% to $645m in the first six months of the year, however it insisted volumes are stable and the decline was driven by "trade buying patterns". Shire may not have too long without additional competition in the market however, as ophthalmology heavyweight Novartis recently bought into the category, licensing phase II candidate ECF843 from Lubris in April.

Dry eye disease causes discomfort, stinging and blurry vision, and can significantly affect quality of life in some patients, impacting activities such as reading and using computers. It is one of the most common conditions seen by ophthalmologists and eye care practitioners worldwide.

The European filing is an "important milestone for lifitegrast and the millions of patients living with dry eye disease, which can impact a person's vision-related quality of life", said Shire's head of clinical development Howard Mayer.

It's also an important product to Shire's ambitions in ophthalmology as its first FDA-approved product and heads a growing pipeline in that therapeutic category, one of its strategic priorities as it tries to grow sales to $10bn a year by 2020.

Shire licensed lifitegrast from SARcode Bioscience in 2013, paying $160m upfront with undisclosed milestones for the drug and added to its portfolio with a $535m deal to license Parion's dry eye candidate P-321, currently in phase II testing.

Rather than submitting the marketing application to the EMA, Shire has filed lifitegrast using the decentralised procedure (DCP) to Denmark, Norway, Sweden, Finland, the UK, Germany, the Netherlands, France, Italy, Portugal, Spain and Greece, with the UK acting as the reference member state.

Eyecare market research firm Market Scope estimates that new drugs will help drive the dry eye market from $3.4bn in 2016 to nearly $4.5bn in 2021, with drugs taking a share alongside over-the-counter eyedrops and surgical devices.

Article by
Phil Taylor

16th August 2017

From: Regulatory

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