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Ionis Retains All Rights To Inotersen, IONIS-FB-L Rx; GSK Declines Its Options

Ionis Pharmaceuticals, Inc. (IONS) Friday said that it has retained all rights to inotersen and IONIS-FB-Lrx. GlaxoSmithKline Plc (GSK.L,GSK) declined its options on both drugs as part of a reprioritization of its pipeline and strategic review of its Rare Diseases business.

Ionis said it 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 or ATTR. The first indication Ionis is pursuing for inotersen is to treat patients with polyneuropathy due to hereditary TTR amyloidosis or hATTR-PN.

Lynne Parshall, chief operating officer of Ionis, said, "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."

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.

GSK, consistent with its focus on treatments for infectious diseases, continues to advance two drugs targeting hepatitis B virus (HBV) under its collaboration with Ionis: IONIS-HBVRx and IONIS-HBV-LRx. GSK is currently conducting Phase 2 studies for both drugs.

by RTT Staff Writer

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