Press release
Insmed Granted Additional U.S. Patent For ARIKAYCE® (amikacin liposome inhalation suspension), Strengthening Brand's Global Patent Portfolio
BRIDGEWATER, N.J., April 9, 2019 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of
About this update from Insmed Incorporated
[{"type":"text","content":"BRIDGEWATER, N.J., April 9, 2019 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued patent No. 10,251,900 for certain uses of ARIKAYCE (amikacin liposome inhalation suspension). The claims of the patent relate in part to methods for treating Mycobacterium avium complex (MAC) lung disease via administration of ARIKAYCE to patients previously unresponsive to MAC therapy. This is the 10th patent issued by the USPTO for ARIKAYCE in MAC lung disease and the second with an expiry date of May 15, 2035. \nARIKAYCE was granted accelerated approval by the U.S. Food and Drug Administration on September 28, 2018, for the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options. \n\"We are very pleased to receive another patent for ARIKAYCE that reinforces our exclusivity in the U.S. to 2035 for methods that align closely with our approved label, further strengthening our global patent portfolio,\" said Will Lewis, Chairman and Chief Executive Officer of Insmed. \"In addition, as we advance toward regulatory filings for ARIKAYCE in Europe and Japan, we are continuing to pursue intellectual property protection in these and other major markets worldwide.\"\nThe methods described in the new U.S. patent relate in part to the treatment of MAC lung infections in patients previously unresponsive to MAC therapy, where the treatment includes achieving a negative MAC sputum culture in the patient. The methods entail administering ARIKAYCE to the patient in combination with a macrolide antibiotic and ethambutol.\nIn addition to 10 U.S. patents, Insmed's global patent portfolio includes eight issued/allowed patents for ARIKAYCE in Japan and five in Europe, with patent protection secured to 2033 and 2035, respectively. \nAbout MAC Lung Disease\nMycobacterium avium complex (MAC) lung disease is a rare and serious disorder that can significantly increase morbidity and mortality. Patients with MAC lung disease can experience a range of symptoms that often worsen over time, including chronic cough, dyspnea, fatigue, fever, weight loss, and chest pain. In some cases, MAC lung...