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.
ABOUT DRY EYE DISEASE
As defined by the 2007 Tear Film Ocular Surface Society International Dry Eye Workshop, dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.
ROP is a potentially blinding eye disorder that primarily affects premature infants weighing less than 2 pounds (about 1kg) who are born before 31 weeks of gestation (a full term pregnancy has a gestation of 38–42 weeks). The smaller a baby is at birth, the more likely that baby is to develop ROP. This disorder, which usually develops in both eyes, is one of the most common causes of visual loss in childhood and can lead to lifelong vision impairment and blindness.
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NOTES TO EDITORS
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas.
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FORWARD - LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical facts are forward-looking statements. Forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:
and other risks and uncertainties detailed from time to time in Shire’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.