Shire Meets FDA for Lifitegrast - Analyst Blog

Shire SHPG announced that it plans to submit a New Drug Application (NDA) for pipeline candidate lifitegrast in the first quarter of 2015, following a meeting with the U.S. Food and Drug Administration (FDA).

Shire is evaluating lifitegrast for the treatment of dry eye disease in adults. In addition, Shire plans to assess the need for collecting additional clinical data in support of other potential international regulatory submissions.

We note that the acquisition of SARcode Bioscience in 2013 added the phase III candidate lifitegrast to Shire's pipeline. The news was encouraging as lifitegrast did not meet one of its prespecified co-primary endpoint (the sign of inferior corneal staining score) in a phase III study, OPUS-2, in Dec 2013 even though the other prespecified co-primary endpoint for the patient-reported symptom of eye dryness was achieved.

Meanwhile, Shire plans to form an Ophthalmics Business Unit (BU) that will focus on the commercialization of its pipeline products in ophthalmology.

Shire has another ophthalmology candidate in its pipeline. We remind investors that the acquisition of Premacure AB in 2013 added a potential protein replacement therapy, premiplex, for the prevention of retinopathy of prematurity ROP to Shire's pipeline. The candidate is currently in a phase II study.

Shire holds a strong position in the attention deficit hyperactivity disorder ADHD market driven by key drugs like Vyvanse, Intuniv and Adderall XR. In a bid to strengthen its portfolio of rare disease drugs, Shire acquired ViroPharma in Jan 2014.

We are impressed by Shire's efforts to develop an ophthalmology portfolio as well. The successful development and commercialization of lifitegrast will diversify Shire's business portfolio and boost the top line as well.

Shire currently carries a Zacks Rank #2 (Buy). Investors looking for better-ranked stocks may consider companies like Allergan AGN, Gilead Sciences GILD, and Alexion Pharmaceuticals, Inc. ALXN. While Allergan and Gilead Sciences carry a Zacks Rank #1 (Strong Buy), Alexion Pharma carries a Zacks Rank #2 (Buy).

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