Press release
Insmed Provides Update on ARIKAYCE® (amikacin liposome inhalation suspension) U.S. Launch
BRIDGEWATER, N.J., April 8, 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 8, 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 provided an update on the U.S. launch of ARIKAYCE® (amikacin liposome inhalation suspension), including preliminary net product sales for the first quarter of 2019. ARIKAYCE was granted accelerated approval by the U.S. Food and Drug Administration (FDA) 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. \n\"We continue to be very pleased with the U.S. launch progress of ARIKAYCE and the positive feedback received from the refractory MAC lung disease community,\" said Will Lewis, Chairman and Chief Executive Officer of Insmed. \"Six months into launch, we continue to see steady increases in patients initiating therapy as well as strong support from payers. We remain very encouraged by the early trends in our first two quarters of launch, while carefully monitoring metrics such as patient dropout rates and duration of therapy. We look forward to providing more information and additional guidance on the U.S. launch during our first quarter earnings call in early May.\" \nThis update will be discussed as part of the Company's presentation at the H.C. Wainwright Global Life Sciences Conference today, Monday, April 8, at 5:50 a.m. ET (10:50 a.m. BST). \nPreliminary Q1 2019 Net Product Sales\nBased on preliminary financial information, the Company expects total net product sales of ARIKAYCE to be approximately $21.9 million for the quarter ended March 31, 2019, comprising U.S. net product sales of $21.0 million and ex-U.S. net product sales of $0.9 million. The ex-U.S. net product sales are comprised of $0.8 million from the Temporary Authorization for Use (Autorisation Temporaire d'Utilisation or ATU) program in France and $0.1 million from the named patient program in Germany, both compassionate use programs. \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 ...