From the 10Q Aug 2014 estimated revenue of Arikayce
Our lead product candidate, ARIKAYCE, or LAI, is a once-a-day inhaled antibiotic treatment engineered to deliver an anti-infective directly to the site of serious lung infections. There are two key components of ARIKAYCE: the liposomal formulation of the drug and the nebulizer device through which ARIKAYCE is inhaled via the mouth and into the lung. The nebulizer technology is owned by PARI, but we have exclusive access to this technology, which is specifically developed for the delivery of our liposomal encapsulation of amikacin, through our licensing agreement with PARI. Our proprietary liposomal technology and the nebulizer are designed specifically for delivery of pharmaceuticals to the lung and provides for potential improvements to existing treatments.
We believe that ARIKAYCE has potential usage for at least two orphan patient populations with high unmet need: patients who have NTM lung infections and CF patients who have Pseudomonas lung infections.
We estimate the combined global market potential for these two orphan indications to be approximately $1 billion.
The following comments from the press release are encouraging and indicate that the potential for positive catalysts may not be that far down the road:
"We have already made extensive preparations for both trials, including design of the protocols and identification of CROs (clinical research organizations). Given the encouraging results of the previous trial, clinicians are keen to work with us to enroll patients quickly. We look forward to continuing to work with the FDA on the regulatory review and to sharing INTERIM DATA from these studies in a timely fashion."
Hmm....interim data on the short trial which ends in the first half of 2016 means that we will probably get the interim data in short order, probably in less than a year from now. What would happen to the stock price if more positive comments from patients emerge on the NTM forums? There could be a run-up in anticipation of confirmatory results.
The market is clear for NTM and the revenues will be significant. But the most important aspect for treatment of this disease will be the fact that people with chronic NTM (like the poster who has had M. abscessus for years) will be treated straight away with Arikayce and not have to endure inferior treatments for those initial years. This direct use of optimum treatment will also preclude exacerbations. I believe this company is going to expedite their efforts to get approvals all over the world. The positions they are recruiting and the cash they just raised suggests strongly that they intend to be a stand alone company in the future. I think 2016 will be the year.
----------- shoot the messenger- catalysts? repost
Insmed has no real catalyst ( but risk) until next year. They are 3 ++ years from revenues ( if approved) in the US which as Wainwright wrote "is where most the company value (Wall st) lies." There is risk in their EMA filing.
So where's the catalyst ? If you are holding out for a Billion dollar takeover- poor investing.
One of the silliest comments is that Cohen and others are "not here not to make money" duhhh, and like those that swallowed up the 10 dollar offering last year and then went onto make a ton, (and not $10 to the 11.25 amount of the current one) they will profit - no matter what happens to Insmed and their drug.
The FDA contrary to popular opinion is also a political entity, the FDA gets a lot of money from large pharmas to run a govt agency responsible for 20% of the US GDP. The manipulators of Wall street and Insmeds competitors won just as I've been posting to the real thrashers of this board.
The golden days of 2013 are over and Insmed remains a $ 1.30 cent stock. Good Luck
There is a reason that I keep the fringe element on both sides on "ignore." Both deny the principles of medicine for emotional reasons or ignorance. Arikayce will have a huge market for NTM because there are no treatments that are predictably effective. The Phase IIb study, which got marginal results was conducted on patients who had been treated for years with therapies that did not work (i.e., were not efficacious in eliminating NTM). Now they have a treatment that got rid of the infection in more than 50% of the patients who were previously "incurable" (cure = no NTM on culture). What medicine tells practitioners is that if you have a better therapy and use it sooner, the patients will benefit. What were the words of the chronic NTM (M. abscessus patient?) I think I could get rid of the infection if I had further access? He is correct. But lets us see if the Phase III included patients that have not had to endure the treatments that are ineffective. Any doctor would tell a patient, the earlier we get you on the best treatment, the lower the risk and the better the chances for efficacy.
INSM will replace the COO in short order, but they do not have to replace the CMO in a hurry. They are not even advertising for a CMO. Why, Dr. Kenneth Olivier. He is the key to NTM and the next two years of INSM progress. The path forward is clear for anyone experienced in FDA regulatory submission or the principles of medicine.
Sorry terry, you are among the ignorant here and the "posse" has you pegged.