Want to know what Sharoky saw in the Transave merger?
Arguably the most encouraging comment from Lewis in his latest investor presentation was this -
"This is very likely GAIN Act, and Orphan, in terms of its status with the FDA".
He made that observation in the part of the presentation which covered the ongoing Arikace NTM clinical trial. But if Lewis is indeed correct in his expectation that the FDA sees Arikace as a potential weapon in the war against pathogens which "have the potential to pose a serious threat to public health" it will be surprising if the FDA doesn't take an enlightened approach to the Arikace label it issues on the strength of the data from the ongoing EU Cystic Fibrosis clinical trial - when one considers that said data will reflect the ability of Arikace to kill a pathogen on the FDA's Most Wanted list - Pseudomonas -
"(4) DESIGNATION PRIOR TO REGULATIONS-
..... The Secretary shall designate drugs as qualified infectious disease products under subsection (d) prior to the promulgation of regulations under this subsection, if such drugs meet the definition of a qualified infectious disease product described in subsection (g).
'(g) Qualified Infectious Disease Product- The term 'qualified infectious disease product' means an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by--
..... '(1) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or
..... '(2) qualifying pathogens listed by the Secretary under subsection (f).'.
'(f) Qualifying Pathogen-
..... '(1) DEFINITION- In this section, the term 'qualifying pathogen' means a pathogen identified and listed by the Secretary under paragraph (2) that has the potential to pose a serious threat to public health, such as--
.......... '(A) resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, and vancomycin-resistant enterococcus;
.......... '(B) multi-drug resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species;
.......... '(C) multi-drug resistant tuberculosis; and
.......... '(D) Clostridium difficile."
The following article is excellent - a must-read for INSM investors. It supports my expectation that the FDA will exercise its new mandate in deeming the data from the ongoing CF study as adequate to support approval of Arikace for all pulmonary bacterial infections for which amikacin injection is already FDA-approved -
GAIN Act, FDA stance only first steps to refilling antibiotic pipeline in U.S.
Sharoky and the former BOD doubtless anticipated the regulatory changes which now make the Transave acquisition look even more impressive than their FOB venture.
One suspects that Insmed always intended to submit a 505(b)(2) Rapid Approval NDA for Arikace, on the basis that Arikace is effectively amikacin with a new method of delivery. Perhaps that's why Lewis didn't mention the GAIN Act until he reached the NTM part of the presentation, as the approved uses of amikacin injection do not include NTM infection -
"Amikacin Sulfate Injection, USP is indicated in the short-term 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."