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Glaxo scuttles Ionis FDA-ready med as CEO sweeps out rare-disease efforts

August 11, 2017

Just three months after Ionis spelled out positive Phase III efficacy data on its top prospect inotersen, GlaxoSmithKline is sweeping their alliance on the drug out the back door, along with rights to another treatment they have rights to.

It’s a stunning 11th hour reversal for Ionis $IONS, which says it now plans to push for an FDA approval of inotersen on its own this fall as it thinks through whether it will commercialize or co-commercialize in the US on its own.

According to Ionis, GSK execs decided to abandon inotersen, designed to treat rare cases of TTR amyloidosis (ATTR), with an initial focus on polyneuropathy due to hereditary TTR amyloidosis (hATTR-PN). That drug is a closely-watched rival to Alnylam’s lead drug patisiran. Also out: IONIS-FB-LRx, now at the threshold of Phase II for dry age-related macular degeneration, as GSK turns its back on rare diseases as part of its top-to-bottom R&D revamp under new CEO Emma Walmsley.

“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.

Filing for approval and getting it are two different things, though. Ionis’ late-stage effort has also been flagged for serious safety concerns which could also hamper its quest for an OK, as well as possibly signing up a new commercialization partner. Paul Matteis at Leerink swiftly noted:

Normally in such a situation like this investors might worry that there’s some not-yet seen-element of the full data that may be problematic or disconcerting. To this point — given the well documented safety issues associated with Inotersen (i.e., thrombocytopenia), GSK’s decision may increase investor scrutiny on TTRrx’s safety profile as it is depicted in additional full data presentations this Fall (American Neurological Association, Oct. 15-17, others). Our model currently assumes a 75%/25% ALNY (MP) versus IONS split, and while we are encouraged that IONS’s plans for a YE17 MAA filing are still on track, we are a bit concerned that GSK’s decision may also put IONS behind the curve with respect to launch preparedness.

Two other alliances will continue. GSK is currently in Phase II with IONIS-HBVRx and IONIS-HBV-LRx.

CEO Stanley Crooke noted that Ionis is now “accelerating the expansion of our TTR program for patients with cardiomyopathy due to TTR amyloidosis and the development of our LICA follow-on drug. Our experience in the completed Phase 3 NEURO-TTR study provides important information to aid in design of a study in patients with cardiomyopathy due to TTR amyloidosis. We have already identified a more potent and convenient LICA follow-on and we expect development of the LICA drug to also proceed rapidly.”

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