Empty Calories: Sugar Pops and Kool-Aid

NeuroPerspective and Neurogram+ readers know that we have been less than enamored with Alkermes and its handling of the ALKS 5461 program–indeed with their R&D bent in general, which tends to be derivative and incremental. It was striking and dismaying to read John LaMattina’s (usually insightful) Forbes column today, wherein he interviewed Alkermes’ CEO Richard Pops about the challenges inherent in developing new antidepressants. What was striking was Pop’s continued, unnuanced spin; what was dismaying to see was LaMattina’s willingness to partake of Pops’ ‘Kool-Aid’ without questioning a couple of the more specious assumptions:
<<So, where does this leave Alkermes and their breakthrough drug program? Pops is optimistic. First of all, FORWARD-4 showed a clear trend toward efficacy on the primary endpoint in the high dose group, and post hoc analyses achieved statistical significance for this same dose group on one endpoint (MADRS).  Then, there is the ongoing FORWARD-5 trial. As Pops said, “There’s no guarantee that FORWARD-5 will be positive.” But, if it is, he believes that the combination of this study, the data from FORWARD-4 which he described as a “near miss”, and the earlier clinical data, could prove sufficient to convince the FDA to approve ALKS 5461. As he said, “This drug has a great risk-benefit profile – it’s a benign agent”>>
Working backwards in this quote, the assertion that the drug has a ‘great risk-benefit’ profile–it’s a benign agent’ conveniently overlooks the side effects reported in Phase II (nausea (34%), vomiting (17%), and dizziness (19%)), which have been ignored by Alkermes itself, other than to state that the Phase III adverse event profile is similar to what was seen before. In other words, ALKS 5461 is no more–and indeed is less–’benign’ than the many drugs already available for depression.  Which means that predicating an unprecedented one-successful-Phase III-NDA on this risk-benefit profile is building on sand.
Pops also stated <<This is the most important depression medicine in 20 years>> No, not really. While ALKS 5461 may have some impact within days, rather than weeks, we would argue that other Rapid-Acting-Antidepressant candidates, including JNJ/Janssen’s esketamine and Allergan’s rapastinel/NRX-1074, constitute a potentially far more radical transformation of the antidepressant paradigm, offering symptom-relief within hours.
Perhaps it is not that surprising that Richard Pops offered the equivalent of biotech ‘fast food’ during the interview, hoping that the sugar and salt would obscure the lack of substance; it was more surprising that someone as experienced as LaMattina would snack on such empty calories.

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