Following a May 15, 2014, meeting with the U.S. Food and Drug Administration (FDA), Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical company, announces today that it intends to submit a New Drug Application for lifitegrast as a treatment for the signs and symptoms of dry eye disease in adults in the first-quarter 2015, as we complete remaining chemistry and manufacturing work. In parallel to preparing for the NDA submission, Shire will be assessing the need for gathering additional clinical data in support of the U.S. and potential international regulatory submissions.
"As we prepare for the FDA submission, we will also form an Ophthalmics Business Unit (BU) that will focus on the commercialization of our ophthalmic pipeline products," said Flemming Ornskov, M.D., CEO, Shire. "This BU will be led by Robert Dempsey, who we recently hired from Bausch & Lomb. Bob has more than 20 years of experience in eye care and has been instrumental in the launches of several well- known eye care products. As we build out the BU, Bob will report to Perry Sternberg, Head of the Neuroscience BU, who also has 10 years of ophthalmology experience. Additionally, on our clinical development team, we have hired Reza Haque, M.D., Ph.D., as Therapeutic Area Head for Ophthalmology, also from Bausch & Lomb. Reza will be responsible for overseeing the lifitegrast and the phase 2 retinopathy of prematurity (ROP) clinical development programs, and any future programs in ophthalmics. Reza brings to Shire more than 20 years of experience in ophthalmics.
"Shire is focused on driving and delivering innovation for the betterment of patients. We're fortunate to have Lifitegrast and our compound for ROP as two potential innovative ophthalmology treatments, and we have every intention of complementing these compounds with additional pipeline products to address significant unmet patient need in ophthalmics," Dr. Ornskov said.
Lifitegrast is an investigational treatment that has been studied in a large clinical development program of more than 1,800 patients. The compound, a small-molecule integrin antagonist, was designed to treat dry eye disease, and is a preservative-free topical eye solution. Lifitegrast is believed to work by reducing inflammation through inhibition of lymphocyte function-associated antigen 1 (LFA-1) and preventing its binding to intercellular adhesion molecule-1 (ICAM-1) that influences T-cell activation and cytokine (protein) release. The interaction between these two proteins plays a key role in the chronic inflammation associated with dry eye. T-cells are important components of the immune system that help control the body's response to a foreign or harmful substance or stimuli.