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Your Daily Pharma Scoop: Achaogen Mixed Ad Com, Esperion Mixed Results, InVivo Up On Old Data

May 04, 2018 8:01 AM ETAchaogen, Inc. (AKAOQ)ESPR, NVIV, CNC, AKRXQ, CLRB7 Comments


  • Achaogen’s Ad Com voted yes for one indication, no for another.
  • ESPR’s bempedioic acid produced solid efficay data but too many deaths in the treatment arm.
  • InVivo is up on data it has published before.

Analysis focus: AKAO

So, the FDA Ad Com finally backed Achaogen’s (AKAO) plazomicin! While that is good that the committee voted 15-0 (1 abstain) in favor of the cUTI indication, it is not so good that they also voted 11-4 (1 abstain) that that the the data failed to provide substantial evidence of the safety and efficacy of plazomicin in bloodstream infections in patients with limited or no treatment options. So they failed on that front, which is a smaller market than cUTI, but still enough of a downer to take the stock down 30% today.

On the other hand, the BSI indication is one where there’s a large unmet need, so one can legitimately wonder about off-label usage in this area. While you cannot sell a bio stock based on its off-label usage, it is also quite possible that at some point there could be an sNDA, or the FDA could reject the Ad Com decision outright and go with an approval right now. After all, it does seem that the review committee’s main objection was the small sample size.

As we have noted before, analysts predicted between $340mn and $525mn for plazomicin sales. Even if we take the lower end of this range now based on the BSI rejection, this is quite a good number for a $516mn biotech. The company has around $150mn in cash reserves and very little debt on its balance sheet. Indeed, some analysts have pegged plazomicin revenue at $150mn in cUTI despite it being a larger market, and $300 in CRE because of the “unmet need” thing. Even if that is true, and these are baseline figures, those are still not bad numbers.

One must worry about dilution, though, given the increased spending required for sales and marketing. The drug will be in the US by

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