Drug Development

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.

The FDA has accepted Merck’s NDA for MK-1293, its biosimilar of Sanofi’s big diabetes blockbuster Lantus (insulin glargine), which was developed in partnership with Samsung Bioepis. Merck looks to follow up with a European approval this year followed by a green light in the U.S. next year. Lilly was the first to come up with a knockoff of Lantus.

Seattle-based Aptevo Therapeutics has come up with a $35 million loan, grabbing the first $20 million on Thursday.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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