"I suggest you surf the FDA website and find Novartis' own presentation in support of TIP (podhaler)"
CF patients already burdened with two or three hours of therapy every day of their lives just love having to put a capsule in the inhaler, piercing it, inhaling, taking a few normal breaths, inhaling a second time, taking the capsule out, checking to see if all the powder's gone, putting it back in if it hasn't and inhaling again, taking it back out and checking again - and having to go through the same palaver a further seven times that day.
No WAY they're going to be interested in a once-daily antibiotic regimen.
But I digress. From Insmed's 10-K -
1. Non-tuberculous mycobacteria (NTM) lung infections - Granted orphan drug designation in Europe and the United States.
2. Pseudomonas aeruginosa lung infections in CF patients - Granted orphan drug designation in Europe and the United States.
3. Pseudomonas aeruginosa and other susceptible organisms causing lung infections in non-CF bronchiectasis patients - Granted orphan drug designation in the United States.
[ if a product which has an orphan drug designation subsequently receives EMA marketing approval for the indication for which it has such designation ... the EMA may not approve any other application to market the same drug for the same indication for a period of ten years ...
Competitors may receive marketing approval of different drugs or biologics for the indications for which the orphan product has exclusivity.
In order to do so, however, they must demonstrate that the new drugs or biologics provide a significant benefit over the existing orphan product. ]
NTM are included in the "other susceptible organisms" referred to in Item 3.
Aradigm is developing a liposomal ciprofloxacin targeting lung infections in non-CF bronchiectasis patients. Looks like they won't be able to market it unless they manage to prove it has a superior risk/benefit profile to Arikace.