Shire Plc recently filed a lawsuit against Allergan Plc, claiming it was involved in a scheme to prohibit physicians from prescribing a new treatment solution for dry eye disease. This disease occurs when a person’s eye produces tears improperly or the eye doesn’t produce enough. Symptoms include eye dryness, overall eye discomfort, stinging, burning, a gritty feeling and episodes of blurred vision. Failing to treat the condition can lead to inflammation, scarring and vision loss.
The complaint was filed with the federal court in Newark, New Jersey. It follows an official statement by Allergan on September 8 in which the company indicated it transferred Restasis patents to the Saint Mohawk Tribe in northern New York to limit legal challenges. The Tribe agreed to license the patents to Allergan.
Shire alleged Allergan violated antitrust laws in an effort to hang onto its 90 share in Medicare prescription drug plans for its “clinically inferior” dry eye solution, Restasis, blocking prescriptions of Shire’s competing option.
Last week, four U.S. Senators instigated a probe to determine whether the unusual move by the company was anti-competitive and made in order to keep drug prices high. Restasis is Allergan’s second best seller, next to Botox, with the company reporting sales of $1.49 billion last year. In the first six months of 2017, the drug induced profits in the amount of $676.4 million compared to Shire’s Xiidra, which brought in $96 million. Both Shire and Allergan are headquartered in Dublin, Ireland and have offices operating in several locations of the U.S.
Shire claimed in its filing, “Quite simply, Allergan has and will continue to use bundled discounts, exclusive dealing, coercion and interference to unlawfully ‘block’ Shire from competing with it, and to maintain its monopoly in the Part D market at all costs.”
Allergan spokesman Mark Marmur responded the lawsuit has no merit, and the company does comply with all Medicare procedures. “Competition in the chronic dry eye therapeutic market has driven pricing down for patients and payers in Medicare Part D and commercial plans,” he said. “Restasis continues to provide significant value to Medicare beneficiaries, providers and the Part D program.”
Shire won U.S. Food and Drug Administration approval in July 2016 for Xiidra, the first dry eye disease solution to win FDA approval since Restasis fifteen years ago. The chemical name for Restasis is cyclosporine, and for Xiidra it is lifitegrast.
Following Xiidra’s approval, Shire’s CEO Flemming Ornskov said, “The approval of Xiidra marks a new day in treatment options for patients with dry eye disease, with the only prescription eye drop approved in the U.S. specifically to treat both the signs and symptoms of the condition.” He continued, “As Shire’s first FDA-approved medicine in ophthalmics, this significant milestone advances our goal of becoming the global leader in this category, where there are unmet patient needs. We have a robust ophthalmics pipeline, and we look forward to leveraging Xiidra as our entrée into the space as we continue to develop additional innovative eye care treatment options.”