Insmed Provides Interim Update from Two-Year, Open-Label Extension Study of ARIKACE to Treat Pseudomonas aeruginosa in Cystic Fibrosis Patients
Initial 12-Month Data Demonstrate Long-Term Safety and Durability of Effect
MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)-- Insmed Incorporated (Nasdaq GS:INSM), a biopharmaceutical company focused on developing an inhaled anti-infective to treat patients battling serious lung diseases in orphan indications that are often life-threatening, provides an interim update from the Company's CLEAR-110 study, an ongoing, two-year, open-label extension study of once-daily ARIKACE®, or liposomal amikacin for inhalation, to treat Pseudomonas aeruginosa (Pa) in cystic fibrosis (CF) patients. These data are from 98 patients who have completed the first 12 months (six cycles) of the CLEAR-110 extension study. The data were collected as part of a scheduled data safety monitoring board (DSMB) review of the CLEAR-110 extension study. The data showed that ARIKACE was well tolerated, and there was a sustained improvement from baseline level in Forced Expiratory Volume in One Second (FEV1). These patients also experienced a sustained reduction in density of Pa sputum while on treatment.
On February 10, 2014, Insmed Incorporated (the “Company”) entered into a Contract Manufacturing Agreement (the “Agreement”) with Therapure Biopharma Inc. (“Therapure”) for the manufacture of the Company’s product ARIKACE TM , liposomal amikacin for inhalation, (“Arikace”). Pursuant to the Agreement, the Company and Therapure will collaborate to construct a production and quality control area for the manufacture and testing of Arikace in Therapure’s existing manufacturing facility in Mississauga, Ontario, Canada. Therapure will manufacture Arikace for the Company on a non-exclusive basis.