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Shire Files Marketing Application for Lifitegrast in Europe

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Shire plc (SHPG - Free Report) announced that it has submitted a Marketing Authorization Application (MAA) for lifitegrast for the treatment of dry eye disease in Europe. In fact, the application has been validated by the UK as the Reference Member State, involved in the Decentralized Procedure (DCP).

If approved, lifitegrast will be the first and only treatment among a new class of drugs. Consequently, it will give a significant boost to Shire’s efforts to build an ophthalmology unit. Notably, the MAA for the drug was supported by data from five clinical trials, including 2,500 patients.

Shares of the company have declined 13.3% compared with the Zacks classified industry’s fall of 2.4% on a year-to-date basis.

It is to be noted that Lifitegras was launched in August 2016 in the U.S. under the brand name Xiidra.  In fact, Shire received a major boost when the FDA approved its Xiidra 5%, a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease (DED) in adults.  

Per the company, Xiidra is the only prescription eye drop indicated for the treatment of both signs and symptoms of this condition. Approximately 16 million adults in the U.S. are diagnosed with dry eye disease, underscoring significant need for treatments in this field. Xiidra also strongly competes with Allergan plc’s (AGN - Free Report) eye care drug Restasis.

Meanwhile, the company has a deep pipeline in ophthalmology comprising early-, mid- and late-stage candidates gained through organic growth and strategic acquisitions. Also, it remains committed to continued innovation in ophthalmics, where there are opportunities to address unmet need, and improve the lives of patients.

Zacks Rank & Stocks to Consider

Shire currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in health care sector include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) and Sanofi (SNY - Free Report) . While Alexion sports a Zacks Rank #1 (Strong Buy), Sanofi holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Alexion Pharmaceuticals’ earnings per share estimates have moved up from $4.55 to $4.77 for 2017 and from $5.49 to $6.43 for 2018 over the last 30 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 12.26%. The share price of the company has increased 10.6% year to date.

Sanofi’s earnings per share estimates have increased from $3.20 to $3.31 for 2017 and from $3.36 to $3.38 for 2018 over last 30 days. The company pulled off positive earnings surprises in three of the trailing four quarters, with an average beat of 5.10%. The share price of the company has increased 18.3% year to date.

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