We had it removed for your own protection.
Insmed's clinical trial didn't meet its primary endpoint - which means the clinical trial must have FAILED. Nobody is interested in secondary endpoints.
You'll just be wasting your time if you listen to the replay of Wednesday's conference call or read the information posted on the INSM board.
1. For the record the CEO finally mentioned MDR-TB as a possible future target during the Q&A session after a recent investor presentation.
2. Way2retire - yes, what should we make of the fact that not one of the biotech analysts following the stock appears to have realized the drug is better suited to the treatment of MDR-TB than anything currently available?
Because most drugs used for TB are off-label it's obvious a safe inhaled aminoglycoside will be used in place of the hazardous injected aminoglycosides currently in joint top spot in order of preference for MDR-TB - at the very least in the treatment of the estimated 31,500 in high-income countries.
You'd have THOUGHT people employed for their analytical skills would have known all along that only an inferior safety profile to amikacin injection could have closed that particular door. Even that unlikely possibility was ruled out from the moment the results of the nine-month dog study were released.
Bedaquiline was approved by the FDA and EMA, and recommended by the WHO and CDC, as a therapy for MDR-TB on the basis of sputum culture conversion during a Phase II study in infection by drug-resistant Mycobacterium Tuberculosis.
Arikace knocks the ball out of the park in the same outcome measure - converting 30 of 52 patients* to sputum culture negative during a Phase II study in infection by drug-resistant Nontuberculous Mycobacteria - and not a single analyst is capable of connecting the dots?
* Patients who had completed the Open Label phase at the point the data was captured for the recent presentation.
Interesting that the FDA recently moved the drug onto one of its fast-track approval pathways by giving it QIDP status. QIDP is supposed to be reserved for drugs which target bacteria which pose a serious threat to public health. But NTM infection is not contagious, so it could never be a threat to public health.
I think the FDA did that because it intends to use the data from the NTM study - a study which was suggested by the NIAID in the first place - to approve the drug to treat both drug-resistant NTM and drug-resistant TB.
I also found this argument about off-label use of the drug compelling:
"" The World Health Organisation reports that in 2012 there were 450,000 cases of MDR-TB globally and 170,000 deaths.
This therapy would be far safer and more effective than the current WHO-recommended course of aminoglycoside injections known to cause loss of hearing and kidney damage.
If injecting amikacin into the bloodstream to kill NTM sheltering within the pulmonary macrophages is nowhere near as effective as delivering concentrated amikacin directly to the NTM - must not the same be true of injecting amikacin into the bloodstream to kill TB sheltering within the pulmonary macrophages?
The 25% cure rate in the NTM study has confirmed that the liposomes enable the amikacin to be released within the macrophages.
If you were a doctor, and a family member became infected with MDR-TB - which of the two would you prescribe? ""
When the Company released the results of this latest study last month it said it would apply for breakthrough therapy designation. The legislation empowers the FDA to approve a product via that pathway if provisional data can be considered reasonably likely to predict a clinical benefit..
It strikes me it all hangs on the FDA's answer. How could the results warrant that designation, but not warrant approval?
Did you know about about the ITFAR connection?
The clinical trial record shows this:
Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
The NIAID is part of the NIH.
I found this on the CDC web page:
The Interagency Task Force on Antimicrobial Resistance was initiated in 1999 following a congressional hearing on the topic "Antimicrobial Resistance: Solutions to a Growing Public Health Problem." The Task Force brings together multiple federal agencies to address the complex issue of antimicrobial resistance.
Currently, representatives from twelve federal agencies participate as members of the Task Force.
Centers for Disease Control and Prevention (CDC)
Food and Drug Administration (FDA)
National Institutes of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
Centers for Medicare and Medicaid Services (CMS)
Health Resources and Services Administration (HRSA)
Department of Agriculture (USDA)
Department of Defense (DoD)
Department of Veterans Affairs (VA)
Environmental Protection Agency (EPA)
Health and Human Services/Office of the Assistant Secretary for Health
Health and Human Services/Office of the Assistant Secretary for Preparedness and Response
I wouldn't advise anybody to buy for the MDR-TB angle unless it's with a view to the medium/long term. The adoption curve is just guesswork.
From memory 95% of TB infection occurs in low and middle income countries - so in the near term the realistic target market seems unlikely to be anywhere near a hundred thousand.
Looking longer term - the WHO has set itself a target of virtually eliminating TB from the planet by 2050, which means that anybody owning a patient-friendly technology for delivering a therapy to the lungs would seem to be well-positioned for an eventual market of two billion people.
It would be useful to know when the WHO plans to make a start on that :-)
So what wasn't he telling us?
He said they already use amikacin injections for hard-to-kill mycobacteria in the lungs whether TB or non-TB.
If this new inhaled amikacin is a better way of killing non-TB why wouldn't it be a better way of killing TB?
The issue here isn't that the drug won't kill TB - but the lack of visibility on sales.
Most TB infection occurs in countries which rely upon foreign aid, where the cost of this drug would be prohibitive - whereas in places like the US, Europe and Japan the mycobacterial infection tends to be NTM rather than TB.
If funding was available for a twelve-week course of the drug for all 630,000 infected with MDR-TB each year, the Company's market valuation at four times sales would equate to over $1,000 a share.
The trick is in accurately predicting what proportion of the MDR-TB patient population is likely to be able to afford the drug any time soon.
But it's worth noting it would take only 10,000 of those 630,000 potential patients to justify the current share price - especially when considering that the analyst price targets of $30 - $40 are based on the Cystic Fibrosis and NTM opportunities alone.
When the Company announces a partner to sell the drug in China - where there is a MDR-TB epidemic and they could afford the drug - the share price will be well over $100.
" Nobody is interested in secondary endpoints. "
I am, as i've heard that it improves fingerprint scanning on the iPhone5s.
" You'll just be wasting your time if you listen to the replay of Wednesday's conference call ... "
Ah ..... another prediction of Apple's Q2 results.
So you're saying those results were NOT proof that the drug will be effective against MDR-TB?
I did wonder if that was too good to be true. An antibiotic which worked against MDR-TB without nasty side effects would be worth billions of dollars in revenue. The analysts would be shouting it from the rooftops.