Press release
United Therapeutics Issues Statement In Response To Meritless Lawsuit
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., April 17, 2019 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) was named as a defendant,
About this update from United Therapeutics Corporation
[{"type":"text","content":"SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., April 17, 2019 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) was named as a defendant, along with Smiths Medical ASD, Inc., in a lawsuit filed in federal court by Sandoz Inc. and RareGen, LLC on April 16, 2019. The lawsuit alleges that United Therapeutics engaged in anticompetitive conduct in connection with plaintiffs' efforts to launch their generic version of Remodulin® (treprostinil) Injection. United Therapeutics issued the following statement in response to the lawsuit:\n\"We are disappointed by these meritless claims against us and expect to ultimately prevail. United Therapeutics was founded with the goal of serving patients with pulmonary arterial hypertension (PAH), and that remains our focus today. In 2015, Smiths Medical publicly announced that it was discontinuing the CADD-MS®3 system, which is used by many patients to deliver Remodulin®, a continuously infused form of treprostinil manufactured by United Therapeutics. In response, we made a significant investment under an agreement with Smiths Medical that ensured the CADD-MS®3 system would continue to be available to deliver Remodulin® for a period of time. Absent United Therapeutics taking this action, thousands of very sick PAH patients may not have been able to access necessary therapy. Meanwhile, we doubled-down on our efforts to innovate and develop new and improved systems to deliver this therapy. \nThis lawsuit stems from Sandoz's and RareGen's failure to take similar steps to ensure availability of a system to deliver their product, despite having eight years from filing Sandoz's Abbreviated New Drug Application (ANDA) to do so. Sandoz and RareGen now seek to make us responsible for their failure to properly plan to serve their prospective patients. We expect the litigation to vindicate our efforts to protect our PAH patients.\" \nAbout Remodulin (treprostinil) Injection\nIndicationRemodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connect...