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Pipeline Progress at Ionis
04/02/2018 5:00 am EST
Ionis Pharmaceuticals (IONS) recently reported its fourth quarter 2017 results with strong Spinraza sales and also provided pipeline updates; we continue to see potential for substantial value creation from the company’s platform, explains biotech sector specialist John McCamant, editor of The Medical Technology Stock Letter.
Spinraza is used to treat spinal muscular atrophy. The $52 million of Q4 Spinraza royalties translates into approximately 14% of the $363 million in sales reported by Biogen (BIIB). Spinraza beat the consensus of $328 million and was driven by ex-U.S. growth.
2018 is an important year for the company with two potential approvals and multiple data readouts expected. IONS has started its commercial launch preparations for both inotersen and volanesorsen.
IONS has a priority review and a PDUFA date of July 6 for inotersen. The company is already preparing for the launch as they have recently said that an FDA AdCom will be unlikely. Thus, IONS will be ready to launch even sooner than July as the approval could come before then.
Importantly, IONS management confirmed on the call that they have not seen any cases of severe platelet declines in the inotersen treated patients nor do they see a need to adjust dose based on patient weight as is proposed with volanesorsen.
On the call, the company noted that the U.S. sales team is already out in the field and the build-out of the medical affairs team is largely complete. This progress has ‘raised the bar’ in terms of what potential partners must bring to the table and the list is narrowing with the potential for a partnership shortly.
Preparation for the volanesorsen global launch continue as IONS aims for a mid-2018 commercialization. Marketing applications are now accepted in the U.S., E.U. and Canada.
IONS continues to execute at a high level and is poised for two significant approvals in 2018. The approvals have the potential to serve as stock catalysts as they would demonstrate the broad potential and further de-risk the deep and progressing IONS pipeline.
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