Global franchise

Following a successful USA launch of Xiidra (lifitegrast) in 2016, Robert Dempsey, the head of the Global Ophthalmics Franchise at Shire, is working to bring the blockbuster dry eye drug to a number of countries around the world, including several in Europe. Shire is a leading biotechnology company focused on bringing novel therapeutics to address unmet medical needs. Shire filed for European marketing authorisation for lifitegrast in August 2017 with a clinical evidence package similar to the one that won FDA approval a year earlier. In clinical trials it demonstrated repeatable improvement in both dry eye signs as measured by corneal staining and symptoms measured by a patient-reported eye dryness scale. “We solved the puzzle. We were the first company to get an indication for both the signs and the symptoms of dry eye disease, the high hurdle that the US FDA has asked for,” Dempsey said. The European application was submitted to Denmark, Norway, Sweden, Finland, the UK, Germany, the Netherlands, France, Italy, Portugal, Spain and Greece, with the UK leading as the reference member state. While Shire awaits word on the filing, they are building out medical and commercial teams throughout Europe. Marketing applications have also been filed in six other countries around the world. “In China alone there are more people with dry eye than the population of the US and Canada combined,” Dempsey said. He estimates there are 30 million people with symptomatic dry eye in the USA, another 30 million in Europe and more than 350 million globally. RAISING AWARENESS In the USA, Shire complemented its lifitegrast launch with a national public awareness campaign on television, in print and online, featuring actress Jennifer Aniston, who said she suffers from dry eye almost every day. Dempsey credits Shire’s activities in the space with helping to grow the overall USA dry eye market, including eye drops, pharmaceuticals and other treatments, by about 30%. Xiidra revenues were $54 million in 2016, accelerating to $96 million in the first half of 2017. Dempsey sees potential in Europe and says Shire is working with clinical societies, leading institutions and key opinion leaders to familiarise them with Shire, and has been supporting presentations, educational supplements and sponsored CME programmes. “It is critical as a new entrant in the space to share with these organisations our mission and goal of becoming an international ophthalmic player.” Dry eye is a multifactorial disease, so Shire is pursuing at least one additional dry eye treatment targeting non-inflammatory causes of dry eye disease. In May 2017, Shire entered into a collaborative agreement with Parion Sciences in North Carolina, USA, to develop a compound that blocks the epithelial sodium channel, slowing tear reabsorption. This helps maintain surface hydration and osmolarity, preventing the inflammatory cascade that leads to dry eye, which could help repair the ocular surface. The compound is in phase II clinical trials. Other drugs in Shire's ophthalmic pipeline include a combination antiseptic and antibiotic for treating bacterial and adenoviral infectious keratitis in phase III trials, and a glaucoma medication in phase I. Together with lifitegrast, these products are making a major player out of a company that only entered the ophthalmic field in 2014. “When I started I was in an office all by myself, and people didn’t know anything about ophthalmology or optometry, so we built a great team. The goal was to build the ophthalmic franchise, launch Xiidra in the US, hire and deploy an international team, and build a strong pipeline,” Dempsey said. The journey continues.

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