Insmed Incorporated (INSM) provided an interim update from the ongoing two-year, open-label extension study - CLEAR-110 - on Arikace. The study is evaluating once-daily Arikace for the treatment of pseudomonas aeruginosa (Pa) in patients suffering from cystic fibrosis (CF).
The data from the study suggested that Arikace was well tolerated. Additionally, sustained improvement from baseline level in Forced Expiratory Volume in One Second (FEV1) and a sustained reduction in density of Pa sputum during treatment was also observed.
We remind investors that in Jul 2013, Insmed reported encouraging results from a phase III study on Arikace for the treatment of Pa in CF patients, when compared to twice-daily Novartis’ (NVS) TOBI (tobramycin inhalation solution). Insmed plans to submit marketing applications for Arikace in the EU and Canada by mid-2014.
Insmed is also conducting a phase II study evaluating Arikace in patients suffering from lung infections caused by non-tuberculous mycobacteria (:NTM). The company completed enrollment for the study in Oct 2013.
Arikace enjoys orphan drug designation for the CF indication both in the U.S. and the EU. The U.S. Food and Drug Administration (:FDA) has also granted orphan drug designation to Arikace for the treatment of NTM lung infections.
We are pleased with the progress in Arikace’s development program as it could be the first product offering once-daily administration for both CF and NTM lung infections and would, therefore, provide patients with a more convenient treatment option.
You mean you do not know that they compared the SOLUTION from Novartis that is being replaced by the portable podhaler?-A Powder? in a device that is PORTABLE! and does not need refrigeration?
Arikace doesnt stand a chance. The podhaler is approved around the world and Arikce? 2 years to go and in Canada and Europe?
This was for our new good friend zake the flake...what a character..
GET INFORMED! BEFORE YOU MAKE A FOOL OF YOURSELF