Your Daily Pharma Scoop: Achaogen Mixed Ad Com, Esperion Mixed Results, InVivo Up On Old Data
Summary
- 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 mid-2018, and in EU probably no later than early next year. If dilution occurs before then - which is a distinct probability - the stock may see some bearish movement. Overall, I like this stock for new entry at well below $10. Above that, and I find it speculative.
Stocks in News: Analysis of ESPR, NVIV
Discussion: Esperion Therapeutics (NASDAQ:ESPR) announced results from its second pivotal Phase 3 study assessing the bad cholesterol-lowering effect of bempedoic acid in high-risk patients with atherosclerotic cardiovascular disease. The trial met its primary efficacy endpoint, but there were 13 deaths in the treatment arm compared to 2 in the control arm. This has spooked investors, taking the stock down considerably. NDA will be filed no later than Q1 2019, but whether these deaths were treatment-emergent needs to be figured out.
InVivo up 69% on previously reported INSPIRE results
Discussion: InVivo (NVIV) is up on huge volume after it announced six-month data from a phase 3 study in spinal cord injury patients assessing its neuro-spinal scaffold. This data was actually announced in January, but was presented at AANS yesterday. The company also readied an equity offering last month.
In other news
Centene (CNC) has priced a stock offering at $107.5 for a total of $2.6bn. Closing date is today.
Akorn (AKRX) has been accused by Fresenius of intentionally submitting fraudulent azithromycin data to the FDA in 2012. The stock is down 8% as this new dimension in the breach of contract suit between the two parties opens up.
Cellectar Bio (CLRB) has been granted a Rare Pediatric Disease Designation for its CLR 131 PET imaging agent for neuroblastoma. The RPDD means issuance of a high value priority review voucher.
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