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GSK Jumps Ship as Ionis Prepares for Key Commercialization of New Drug

Ionis Pharmaceuticals has been dropped by its big pharma partner, GlaxoSmithKline, just before the Carlsbad drugmaker was about to file for marketing approval of a new drug.

Ionis announced Aug. 11 that it has regained full rights for a drug called inotersen, which just wrapped up Phase 3 trials in May. The drug is meant to treat a rare, crippling nerve condition called familial polyneuropathy (FAP), which has no available treatments in the U.S.

GlaxoSmithKline dumped the drug, along with another experimental drug Ionis is developing for an eye disease. The departure from the partnership is likely due to the global pharmaceutical company’s pivot away from rare disease programs. GSK’s new CEO Emma Walmsley laid out plans late last month to cull more than 30 programs from the company’s pipeline, and apparently Ionis is one of many companies to be affected.

GSK’s jilt comes at a critical time for Ionis, which is preparing to ask the U.S. Food and Drug Administration for marketing approval on inotersen. The company is in a race with another drugmaker, Alnylam Pharmaceuticals, to be the first company to bring the nerve drug to market. Although Ionis has already completed Phase 3 trials (while Alnylam is still wrapping up its Phase 3 trial), the Carlsbad company needs to stay a step ahead to scoop the commercial market.

Now, Ionis will have to either go at commercialization alone or line up a new commercial partner ASAP. Ionis said in a company statement that it’s in discussions with new partners to replace GSK, and may decide to form a subsidiary to help sell inotersen in North America.

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