"Bottom line is that Lewis conveyed what some of us spumpers have mentioned before.... that arikace is a part of a technology drug platform, and in the future there will be other "things" wrapped around those unique liposomes."
- it's worth highlighting one or two insights which offer a compelling argument for the bashers to be wearing their brown pants every day from now on.
1. From the 10-K -
"Our current priorities are as follows.
..... Attempt to source promising late stage or commercial products that we believe are complementary to ARIKACE and our core competencies.
..... We will continue to evaluate opportunities for additional products through various business development channels."
One assumes the Company is "currently" pursuing therapies for pulmonary conditions which have outstanding potential and are suitable for delivery via inhaled liposomes. These targets wouldn't necessarily be antibiotics.
2. The addional colour from Lewis -
"Well, Robert, if you mean with respect to the underlying technology, it's probably worth commenting that while we don't draw a lot of attention to it, there are other projects that are ongoing within the company. I like to characterize for investors that the myopic focus of the company right now is securing the approval of ARIKACE in cystic fibrosis patients who have Pseudomonas lung infections and patients who have NTM lung infections. But this technology does have broader application, and there are certainly some other areas where we're seeing opportunities. And I would say, at this stage, we're quietly pursuing those. It would be important for people just from a capital use point of view to understand that should we continue to see progress in those areas, it would be our intention to partner those development efforts ..."
Interesting that he said -
"should we continue to see progress in those areas"
It's also worth noting that while particularly risk-averse investors with a near-term focus (as opposed to a five-year view) may stay on the sidelines until they know for sure the Cystic Fibrosis study has gone well, this news from the dog study may be all that was required from the point of view of certain interested parties.
It's unsurprising that the FDA originally denied Transave the 505(b)(2) route to approval. Although the duration of a normal course of antibiotics is so brief as to have been covered on the safety side by the initial toxicity studies (including, one assumes, the earlier three-month study in dogs), the long-term risks associated with prolonged or frequent use of inhaled liposomes were unknown.
The lungs were not designed to cope with the inhalation of lipids, just as they were not designed to cope with the inhalation of cigarette smoke, asbestos etc. But the data from the dogs which inhaled Arikace daily for nine months will hopefully have convinced the FDA that there is no anticipated use in humans with the potential to overload the mechanisms of pulmonary clearance.
That assurance, together with a warning on the label that rats exposed every day for two years to twice the recommended dosage developed tumours, seems likely to have made the risk/benefit profile of inhaled liposome therapy acceptable - and superior to that of any pulmonary therapy currently delivered by tablet or injection.
That issue will probably have been the only concern of an interested company with a product likely to transformed by inhaled liposome delivery.
Fud, I try to pay close attention to words, but totally missed that. Thanks. Very interesting, as the total market for pulmonary delivery drugs is several times the size of the pulmonary antibiotic market.
So, on the conference call we found out:
The dog tox study appears fine.
iPLEX could be back in play with a multi-billion cap company leading the charge.
QIDP may come by mid year.
Breakthrough dug therapy may be applied for after some NTM data is reviewed.
Those liposomes may be getting wrapped around other drugs that we are not aware of - with some success!
In April Insmed may get a check for 11 Million dollars.
Still no reason to believe the next three months and 10 days won't be really interesting.