The February investor presentation is on the Insmed website today.
There is more detail given regarding the In Vitro study at Oregon State regarding the effect of arikace on MAC and M. abscessus. Interestingly arikace had better In Vitro activity against these pathogens then free liquid amikacin did.
Regarding the NTM trial, under the key takeaway section, Insmed highlights the potential for an accelerated path to approval.
In addition there is a footnote regarding TOBI. Apparently at the September meeting of the FDA - Anti Infective Drugs Advisory Committee meeting, a presentation was given where the FDA now contends that resistance to TOBI has risen by 50% since 1999. Achieving non inferiority in the ongoing Cystic Fibrosis trial is nearly a given taking available information into account. And yes, we all know that superiority, not non inferiority over TOBI is necessary to have a quick and widespread switch from TOBI to arikace upon approval.
On the subject of competitive drugs to Arikace it's worth noting Rehdvm's ploy of pretending to believe that NTM is the biggest opportunity for Arikace.
The reason Rehdvm persists with that lie - despite having it pointed out to him that (just like NTM) the Non-CF bronchiectasis population also does not have approved access to any inhaled antibiotics, and is over eight times larger - is that Rehdvm is hoping to promote the fallacy that Arikace will only be approved as a Cystic Fibrosis therapy initially, and will have serious competition from the established therapies in that space.
It suits Rehdvm's agenda to misrepresent the argument of the shareholders who use this forum, by claiming we have been predicting a permanent maintenance therapy for chronic pseudomonas infection in Cystic Fibrosis and Non-CF bronchiectasis involving Arikace only.
But he knows full well we are aware of the necessity of antibiotic rotation in any permanent therapeutic regimen.
However, compelling Phase III data from the ongoing EU Arikace study will, imo, render TOBI therapy as virtually obsolete - and leave the alternative therapies such as Cayston fighting for use as a rotational drug to Arikace.
Antibiotic rotation is designed to minimise the potential of drug-resistant strains developing (as indeed appears to have happened following prolonged TOBI monotherapy). If the Phase III data due in Q2 do evidence far greater efficacy for Arikace compared with TOBI, Arikace will surely displace TOBI as the gold-standard therapy for pseudomonas infection in Cystic Fibrosis. And a physician looking for a rotational drug to use in the Arikace off-therapy period of the cycle will surely look for a drug which isn't (as TOBI is) another aminoglycoside.
It's also worth noting the reluctance of "regulatory expert" Rehdvm to discuss the suggestion that Insmed has been planning all along to submit a 505(b)(2) "Rapid Approval" New Drug Application for Arikace.
The 505(b)(2) pathway is designed for scenarios where a more effective way has been discovered of using a drug already approved by the FDA. In this case Arikace is clearly a more effective use of injected amikacin (the "reference drug" under the 505(b)(2) pathway). It's a "Rapid Approval" pathway by virtue of the fact that the FDA deems included in the NDA all of the efficacy and safety data from the clinical studies of the reference drug.
In the case of amikacin, that efficacy and safety data were adequate to support the following approved uses of injected amikacin -
"the treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter (Mima-Herellea) species."
And the only four Gram-negative bacteria named in the legislation signed last year as examples of pathogens having the potential to pose a serious threat to public health were "multi-drug resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species".
When one factors in the mandate given to the FDA under the new legislation of pathogen-focused antibacterial drug development as a proactive measure against these potential threats to public health, perhaps it shouldn't come as any great surprise if the FDA approves Arikace for -
"the treatment of serious pulmonary infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, Klebsiella-Enterobacter-Serratia species, and Acinetobacter (Mima-Herellea) species."
Rehdvm - isn't it about time you stopped avoiding this topic?