According to Insmed, the US Patent and Trademark Office has issued the company a second composition of matter patent for Arikace liposomal amikacin for inhalation, US Patent No. 8,226,975. Insmed is developing the product for the treatment of cystic fibrosis and non-tuberculous mycobacteria (NTM). The company recently decided to defer a Phase 3 study of Arikace in the US while it is conducting studies in Europe.
The patent is for “A system for treating or providing prophylaxis against a pulmonary infection is disclosed comprising: a) a pharmaceutical formulation comprising a mixture of free antiinfective and antiinfective encapsulated in a lipid-based composition, and b) an inhalation delivery device. A method for providing prophylaxis against a pulmonary infection in a patient and a method of reducing the loss of antiinfective encapsulated in a lipid-based composition upon nebulization comprising administering an aerosolized pharmaceutical formulation comprising a mixture of free antiinfective and antiinfective encapsulated in a lipid-based composition is also disclosed.”
Insmed Executive VP of Development and Chief Medical Officer Renu Gupta commented, “The issuance of this second composition of matter patent expands our already extensive intellectual property position around Arikace. Our Arikace development plan is progressing well in both CF and NTM, and we are projecting top-line results in mid-2013 and fourth quarter 2013, respectively.”
Read the Insmed press release.
