I understand why Lewis is not allowed to initiate discussion on the use of Arikace in any indication apart from Cystic Fibrosis and NTM.
But it seems highly suspicious to me that not a single analyst participating in the quarterly calls and investor presentations has ever acknowledged the wider potential of Arikace. It seems to me that it would be really convenient for institutional investors if the shares were still significantly undervalued when the Company conducts its next share offering prior to commercialisation.
CDC statistics indicate that in 2009 1.1 million people in the United States were hospitalized with pneumonia.
In 2019, how many people in the US hospitalised with pneumonia are likely to be treated with an Insmed antibiotic?
Useful reading for newbies -
Aerosolized Antibiotics for the Treatment of Nosocomial Pneumonia (Klepser 9 Nov 2012)
Rising Threat of Infections Unfazed by Antibiotics (New York Times)
GAIN Act, FDA stance only first steps to refilling antibiotic pipeline in U.S. (BioCentury)
"In connection with the FDA's decision to lift the clinical hold for all disease indications, we agreed to conduct a 9 month dog inhalation toxicity study of ARIKACE. In late January 2013, we concluded the 9 month dosing phase of the dog inhalation toxicity study.
Consistent with the design of the study, we conducted a review of the lung and kidney tissues in the first group of dogs upon completion of the 9 month dosing. Additionally, a group of dogs designated for the recovery period of the study continue in the off drug observation period.
As agreed with the FDA, an unaudited interim report of the findings from the first group of dogs that completed 9 months of dosing was recently submitted to the FDA. In summary, this report stated that the lung macrophage response in the first group of dogs was similar to that seen in our previous 3 month dosing dog study, and there was no evidence of neoplasia, squamous metaplasia or proliferative changes.
We also informed the FDA that we are planning the recovery period to be 3 months as there were no findings of note at the end of the 9 month dosing phase."
"You highlighted an excellent point, though, more broadly, which is that in the anti-infective space generally, what we're seeing is a real engagement on the part of regulatory authorities where there is efficacy and safety to find a pathway forward to get these drugs onto the market, whether it's through breakthrough therapy, QIDP designation or, indeed, just evaluation of final data outcomes, has been seen with other products as well.
There's just a real need for anti-infectives generally and any arrow in the quiver is going to be welcomed by the regulatory authorities, we believe, both here and in Europe."
Hmm ... "or, indeed, just evaluation of final data outcomes". Something like ... if Arikace is safe and kills Pseudomonas, it should kill the other three gram-negative public health threat pathogens - E.coli, Klebsiella and Acinetobacter?
For anybody who missed the implication - why would anybody even consider treating a pulmonary infection with an antibiotic administered by tablet or injection if that antibiotic was also available in an inhaled liposome formulation?
Lipid build-up in the lungs seems likely to be a non-issue over a course of treatment of just one or two weeks. And would a therapy which costs less necessarily work out cheaper in the long run?
ECCMID April 2012 -
"The addition of a short-course of high-dose aminoglycoside to initial antipseudomonal beta-lactam therapy can improve the treatment of healthcare-associated pneumonia by shortening the length of hospital stay, researchers said here at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
Limited treatment options and delays in empiric therapy for multidrug resistant gram-negative organisms (MDR-Gn) are said to be largely to blame for the unsettling rise in such infections, causing increased lengths of stay, costs, and mortality resulting with infections.
Healthcare-associated pneumonia has been shown to be associated with particularly resistant pathogens, and a combination therapy in which aminoglycoside is added to antipseudomonal beta-lactam has been suggested to improve treatment and resolve symptoms faster than monotherapy.
In testing the efficacy of the combination therapy, researchers evaluated a group of 227 geriatric patients with nursing home acquired pneumonia, in which 104 patients received a combination therapy of antipseudomonal beta-lactam plus aminoglycoside and 123 received beta-lactam therapy without an aminoglycoside between 2009 and 2010.
The results showed that the combination aminoglycoside therapy group had a mean length of stay that was 1.83 days shorter than the non-combination therapy group, resulting in lower overall inpatient costs."
"But it seems highly suspicious to me that not a single analyst participating in the quarterly calls and investor presentations has ever acknowledged the wider potential of Arikace..."
Really?!? Just how MANY analyst are following Insmed with coverage, anyway? Up until very recently, we only had one/Webush, right?!
Fud,,If you're truly amazed that no one has acknowledged the wider scope of indications by INSM
in a conference call, why don't you call, and ask the question? Maybe we would all be better served
if you where to do so. It would certainly lower the level of banter and ponderonce that exists here, and
give you and us a level of understanding by how the question is either answered or not...I will look
forward to hearing your question Monday morning,,,if you don't mind revealing your true identity.
Zake, that brings up a good point. I have often wanted to ask a question on the calls, but really don't want my identity to be known to everyone - do you think I would get in any trouble if I "changed" my name when I call in Monday?
My question would be about the dog trial. I was told yesterday that Insmed was likely told to contact the FDA if certain outcomes materialized, but to just submit it when and if they file their NDA if those outcomes did not occur. The dog trial was such a big deal that I have been waiting for an 8k, but maybe I should stop waiting.
Dorian - that would be of more comfort to me if I knew for sure Lewis has been playing for our team.
1. "On September 10, 2012 ... William Lewis was appointed as the Company's new President and Chief Executive Officer ..."
2. "As previously disclosed in a Form 8-K filed on September 28, 2012 Insmed Incorporated (the "Company") completed a registered direct financing with three investors on that date pursuant to which the Company issued 6,304,102 shares of common stock. The price at which the common stock was sold in the financing was $4.07 per share, equal to the closing bid price for the Company's common shares on the day prior to the issuance. On October 5, 2012, the Company received telephonic notice from its outside counsel on the transaction that the Staff (the "Staff") of The NASDAQ Stock Market LLC ("Nasdaq") had informed such counsel of the Staff's belief that the sale of the shares did not comply with Nasdaq Listing Rule 5365(d). The Staff's concern was based on the fact that the shares were sold at a price that was below the book value per share of the Company as reflected in the Company's Form 10-Q for the quarter ended June 30, 2012. As a result, it was the Staff's belief that, pursuant to the Nasdaq Listing Rules, the Company was not permitted to issue 20% or more of the Company's outstanding common shares, even though the sales price per share was equal to the market value per share on the date immediately preceding the issuance.
Following communications by the Company with the Staff, on October 12, 2012, the Company received a Letter of Reprimand from the Staff pursuant to Listing Rule 5810(c)(4), based on its noncompliance with Listing Rule 5635(d)."
From Insmed's United States Patent Application 20130028960 -
"In a further embodiment, the present invention relates to the aforementioned method, wherein the aerosolized pharmaceutical formulation is administered at least once per week. In a further embodiment, the present invention relates to the aforementioned method, wherein the antiinfective is selected from the group consisting of antibiotic agents, antiviral agents, and antifungal agents. In a further embodiment, the antiinfective is an antibiotic selected from the group consisting of cephalosporins, quinolones, fluoroquinolones, penicillins, beta lactamase inhibitors, carbepenems, monobactams, macrolides, lincosamines, glycopeptides, rifampin, oxazolidonones, tetracyclines, aminoglycosides, streptogramins, and sulfonamides. In a further embodiment, the antiinfective is an aminoglycoside. In a further embodiment, the antiinfective is amikacin, gentamicin, or tobramycin."