In an article published in The Street earlier this month, veteran biotech stock pundit Adam Feuerstein claims that “there are legitimate concerns about what [biopharmaceutical company] Ionis discloses about the safety and tolerability of its antisense drugs in clinical trials”.
According to Feuerstein, the company in 2013
emailed copies of its newly updated corporate presentation to institutional investors scheduled to meet with the company’s executives. Unbeknownst to Ionis, the presentation formatted for investors included, by mistake, information meant for internal eyes only. Three slides in the deck titled “Lessons Learned From Kynamro” summarized Ionis’ experience dealing with the Food and Drug Administration and Wall Street during the contentious clinical review of the cholesterol-lowering drug.
Ionis insisted that it was committed to the full disclosure of all side effects of drugs in its pipeline. However, after The Street published one of the slides online, some pundits in the Twittersphere remained unconvinced:
— Harlan Krumholz (@hmkyale) August 5, 2016
Feuerstein himself also struck a skeptical chord:
It’s important to remember these slides were created two months after Ionis emerged bruised from an October 2012 FDA advisory committee meeting convened to review Kynamro, a drug the company had long touted as a potential blockbuster. At that meeting, the FDA raised concerns about serious side effects and tolerability issues related to Kynamro injections. More than half of the patients enrolled in the pivotal Kynamro studies dropped out early to due to side effects. Investors first learned about the extent of Kynamro’s safety issues at the FDA meeting because Ionis and partner Genzyme had not fully disclosed results from the drug’s clinical trials. (…) Even with the Ionis denial of any wrongdoing, investors who remember the Kynamro experience and have seen this slide tell me it makes them think twice and be less trusting of clinical data reported by the company, even three years later.
In July 2015, a coalition of 85 pension funds and asset managers representing more than €3.5 trillion in assets joined the AllTrials campaign, calling on the pharmaceutical companies they had invested to set out their plans to get clinical trials, past, present and future, registered and results reported.
Feuerstein’s article was published in The Street on 5th August 2016 and can be accessed here.