Therapure Biomanufacturing, an integrated contract development and manufacturing organization (CDMO) and a division of Therapure Biopharma Inc. (Therapure or the Company), today announced approval for the manufacturing of Insmed Incorporated's ARIKAYCE® at its Mississauga facility by the U.S. Food and Drug Administration (FDA).
FDA granted accelerated approval of Insmed's ARIKAYCE (amikacin liposome inhalation suspension) on September 28, 2018, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options.
As one of the key manufacturing partners for ARIKAYCE, Therapure has built a custom manufacturing suite and is responsible for scale-up, commercial aseptic formulation and fill/finish manufacturing, under an agreement signed by the two companies in 2014.
ARIKAYCE is the first and only treatment approved by the FDA specifically for patients with Mycobacterium avium complex lung disease, a chronic and debilitating condition that can significantly increase patient morbidity and mortality. ARIKAYCE manufactured by Therapure is expected to be available in select specialty pharmacies in the coming weeks.
Nick Green, Therapure's President and Chief Executive Officer, said: "We are privileged to partner with Insmed in the commercial manufacturing of this important therapy that leverages innovative drug delivery technology to address previously unmet but 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 that make a difference in patients' lives."
Gabriel de Alba, Chairman of Therapure and Managing Director and Partner at The Catalyst Capital Group Inc., concluded, "Following much hard work and dedication by the Therapure team, as well as support from Catalyst, Therapure's advanced manufacturing capabilities have been proven again. Complex biological therapeutics and innovative drug delivery technology can improve people's lives, and we look forward to continuing to work with important partners like Insmed to bring these opportunities to market."