Ionis Pharmaceuticals, Inc. reported that the Company has retained all rights to inotersen and IONIS-FB-LRx. As part of a reprioritization of its pipeline and strategic review of its Rare Diseases business, GSK declined its options on both drugs. Ionis plans to file for marketing authorization for inotersen this year to support a commercial launch of inotersen in 2018. Inotersen is a drug designed to treat patients with TTR amyloidosis (ATTR). The first indication Ionis is pursuing for inotersen is to treat patients with polyneuropathy due to hereditary TTR amyloidosis (hATTR-PN).
“We are pleased to move forward these two important drugs ourselves. We are prepared to independently advance inotersen and remain on track to file for marketing approval of inotersen in the U.S. and EU this year,” said B. Lynne Parshall, chief operating officer of Ionis Pharmaceuticals. “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.”
Ionis completed the Phase 3 NEURO-TTR study of inotersen in which the drug demonstrated significant benefit on both primary clinical endpoints of neurological disease progression and quality of life in patients with hATTR-PN.
“Our goals for inotersen are to maximize its commercial success and optimize our commercial participation. 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. We have substantial interest from potential partners and are in discussions with several parties. We believe that, together with the right commercial partner, we can maximize the commercial success of the drug worldwide,” said Sarah Boyce, chief business officer of Ionis Pharmaceuticals.
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