Protocols: Did Ionis set out to exclude side effects? Merck takes another step forward with Lantus biosimilar
Biotech’s most feared reporter, Adam Feuerstein, has not been a big fan of Ionis. And it’s unlikely that there’s much love lost these days at the antisense RNA company. This morning, Feuerstein published a slide that the company mistakenly included in a batch sent out to analysts, which included a few key strategic moves it made in the wake of its troubles with Kynamro. The list begins: “Reduce focus on eliciting side effect reports in Phase 2/3.” And it goes on to suggest not soliciting reports on injection site reactions and flu-like symptoms, better “guidance” on that and fewer lab chemistries. “One troubling interpretation of this slide suggests Ionis, learning from the painful Kyanamro experience, intended to under-report side effects of its other antisense drugs in mid- and late-stage clinical trials,” Feuerstein reports. The company denies it intended any such thing, but this is the kind of reporting that can come back and haunt a biotech after the next big setback.
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