Ionis Pharmaceuticals Inc. will retain all rights to inotersen and IONIS-FB-LRx.
"We are pleased to move forward these two important drugs ourselves," B. Lynne Parshall, chief operating officer of Ionis Pharmaceuticals, said in a statement. "We are prepared to independently advance inotersen and remain on track to file for marketing approval of inotersen in the U.S. and E.U. this year. We want to thank our collaboration team at GSK for their support and commitment to patients with TTR amyloidosis, and their efforts to work closely with us to ensure a smooth transition so that this important medicine can be available to patients as planned."
GlaxoSmithKline Pharmaceuticals Ltd. (GSK) declined the option it previously held on both drugs, opting to instead prioritize other projects in its rare diseases business pipeline. Ionis will now work toward filing for marketing authorization for inotersen. The company hopes for a commercial launch of inotersen in 2018.
"Our goals for inotersen are to maximize its commercial success and optimize our commercial participation,” Sarah Boyce, chief business officer of Ionis Pharmaceuticals, said. “ To achieve these goals, we are actively considering forming a commercial subsidiary to commercialize or co-commercialize inotersen in North America, as well as other options. Our recent experience building a commercial subsidiary has prepared us for this opportunity.”