MISSISSAUGA, Ontario, April 29, 2014 (GLOBE NEWSWIRE) -- via PRWEB - Therapure Biomanufacturing, a division of Therapure Biopharma Inc., announced today the signing of an agreement with Insmed Incorporated for the manufacture of ARIKAYCE, liposomal amikacin for inhalation.
Therapure Biomanufacturing is an integrated contract development and manufacturing organization (CDMO) focused on biologic and high value therapeutics that can provide new options for patient care. Under this agreement, Therapure will be responsible for the construction of a custom manufacturing suite for scale-up, commercial aseptic formulation and fill/finish manufacturing of Insmed's ARIKAYCE at the Therapure facility in Mississauga, Ontario. Innovative technologies, such as the proprietary liposomal encapsulation process utilized in ARIKAYCE, are complementary to Therapure's capabilities in the cGMP manufacturing of complex therapeutics.
Mr. Nick Green, Therapure's President and Chief Executive Officer, said: "We are delighted to partner with Insmed to assist with the advancement of this innovative technology for serious and life-threatening pulmonary diseases. Therapure prides itself on its development, clinical and commercial cGMP manufacturing expertise providing solutions for biologic therapeutics and innovative drug delivery technologies, which make a difference in patients' lives."
"Insmed looks forward to working with Therapure for the commercial supply of our key drug candidate ARIKAYCE. Therapure's proven cGMP manufacturing capabilities and expertise with aseptic formulation will support the planned global commercial launch of ARIKAYCE," said Dr. Peter Clarke, Insmed's Vice President of Technical Operations.
This was not announced by Insmed - Therapure instead. Maybe Historian is correct that Insmed is in a quiet period? Either way. this is another step towards the PLAN (wonder if they needed a "nod" from the FDA or EMA to move forward? Both could think this is presumptuous.
Rook. The FDA might think this is presumptious, but they know there are many sufferers of NTM, and are in need a treatment for this unmet medical condition. Maybe this is like the "Field of Dreams", If you build it, they will use it!