Forest's inhaled cystic fibrosis treatment Colobreathe cleared by
EU to market Colobreathe (colistimethate dry powder for inhalation) for treating patients aged 6 years and older with cystic fibrosis (CF) and chronic lung infection caused by P. aeruginosa.
Turbospin inhaler device, will be launched "first in Germany by mid-2012 closely followed by other European countries and the UK in September."
The company noted that the EMA's decision was based on data from a trial comparing the efficacy of Colobreathe to Novartis' TOBI (tobramycin nebuliser solution for inhalation). Forest said that results showed the ability of Colobreathe "to prevent deterioration of respiratory function" in patients with CF, while demonstrating the product's "better patient acceptability" when compared to TOBI. Data also indicated that there was no emergence of antibacterial resistance with Colobreathe.
comes up when a search for "inhalation colistin antibiotic" are used as keywords. So the use of this drug through extra label prescription by physicians is also on this side of the pond. That makes it fair game for the US because of the close ties of Canadian HPB and FDA.
shows an announcement in February 2012 in NY and Dublin.
Further citations indicate the inhalation powder was approved because of "modest improvement in FEV" with "no greater side effects than TOBI."
The drug is described as a polymixin antibiotic which are among the most potent against bacteria and toxic. But the powder form in the lungs appears not to go systemic which reduces toxicity. (Note: Neosporin ointment has polymixin, bacetracin and chloramphenacol which will kill any bacteria, but can only be used topically or in the eyes).
The approval seems to be associated with powder delivery and not needing a nembulizer. The switch to tobramycin dry powder appears to be a similar attempt at improving the use of that drug. Also the Samsung study in South Korea for amikacin dry powder parallels these evolving uses of antibiotic. If only INSM had not lost more than 7 months on hold, they might be presenting their first study results. These other powdered forms must not have foamy macrophages as a side issue.
you never replied...i proved that you own no shares...so why are you here?
first you said you were making money shorting here, soon thereafter you said you were neither long or short, then you say you will be a buyer at $2.75 even tho you have not opined one positive thing about this stock
mostly i say you are full of crapola