Epilepsy and PPD just the beginning. SAGE has the potential to be a huge player in this space years from now - provided they don't get purchased before that. Reminds me of Vertex back in the late 90's (now a 30 Billion dollar company).
Non-inferior simply means that eravacycline performs as well as current standard of therapy. In this case it was compared to levofloxacin. What we'd also expect is that eravacycline would be available to use against levofloxacin resistant bacteria, providing an alternate therapy where one doesn't exist. Further, the data seemed to suggest that the responder outcomes in the ITT arm seemed to respond about 20% better to eravacycline vs levofloxacin. You couldn't ask for better phase 3 results IMO, especially with the recent focus from the FDA around fast tracking antibiotic therapy's.
Forget non-inferiority compared to levofloxacin, in many cases eravacycline appears to be superior. Today's results de-risk TTPH. This is pretty much a buy and hold for acquisition. Perhaps after the pivotal portion of IGNITE2 completes or just ahead of NDA Filing. Comments?
The design of the trial was flawed. Unsurprising that it failed. However it doesn't change how the drug performs. A trial designed to assessment cardic parameters would have succeded. I can't explain why they choose time to rehospitilation as a primary endpoint. So while a Phase 2 trial failure is never good the drug itself is just fine. This will likely be discussed in the call. There is to much interest in improving CHF outcomes to give up. That will be the theme here.
Conference in Miami.
The general sense is that Tetraphase will be bought before Phase 3 results come out. Brean's report confirmed prevailing street sentiment. Any thoughts on what a deal might look like? Prrojected sales x2 seems reasonable given what we saw with Merck and Actavis, but when you add in CRE, it seems the value may be higher. Assuming eravacycline has the potential to be a billion dollar drug (particularly given CRE efficacy), that would put us around a $74 buyout. Thoughts on who might be interested? It wasn't mentioned in Brean's report Friday, but perhaps Glaxo or Pfizer would be interested to compete with Merck's acquisition of Cubist.
Solid growth, and tremendous upside potential with new Ebola test.
Wished I'd paid closer attention. That brand new Caliber lab clearly was built as part of government contingency plan that is now being placed into effect. Looks like IBIO stands to make significant royalties.
Both the head of the NIH and HHS acknowledged that NewLink is actively manufacturing vaccine. I particularly liked hearing the head of HHS mention that they are reviewing contract proposals from NewLink. That's sounds to me like some government contract money is headed NewLinks way in the next week or so, and there is a verbal agreement to ramp manufacturing in advance. Probably explains why they have government staff onsite.
Check CSPAN video of Friedman testimony. NewLink discussion is 1:30:10 into video. Panel acknowledged that federal government is onsite as production is ramped. Also notes that HHS is working with the company on contracts with favorable terms.
I suspect they are attempting to establish efficacy of available drugs with the live Ebola cases we're seeing. Sadly today Brincidofovir (trial size n=1) failed. Zmapp had one success, as did TKM-Ebola. Perhaps they try Sarpeta's drug next. This might provide some early guidance on which drug should be stockpiled.
Unfortunately it has never been tested against a single strain of Ebola - not one study to date. It's only been used on adenovirus (AdV) and cytomegalovirus in a couple studies, while similar, they are different enough that efficacy is not certain. The Dallas patient demonstrated that today. It's very likely Brincidofovir will not prove effective in this outbreak. Investors are better off focusing on Sarpeta or Tekmira, both have drugs which have been tested in lab studies and proven effective against Ebola strains.
It's just that simple. This is starting to look like a movie script.
You'll see Big Pharma making competing offers, that will drive this well north of $100.