Insmed has announced the appointment of Martina Flammer as Chief Medical Officer, effective mid-December 2019. Flammer was most recently Senior VP Customer Value at Boehringer Ingelheim and her previous positions include VP Medicine, Regulatory Affairs & Pharmacovigilance at BI Canada; VP Clinical Development & Medical Affairs of BI’s Specialty Care Business Unit; and Senior Medical Director at Pfizer.
In September 2018, the FDA approved Insmed’s amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in a limited patient population. The company said that it anticipates full-year 2019 total revenue for Arikayce of $133 million to $138 million and is investing in “buildout of an additional third-party manufacturing facility to increase long-term production capacity” for Arikayce.
Insmed said at the time of approval that it would conduct a study aimed at expanding use to all patients with NTM lung disease caused by MAC. The company now says that it “continues to advance the post-approval confirmatory clinical trial for Arikayce” and plans to conduct the study “in a frontline setting.”
Insmed Chairman and CEO Will Lewis commented, “We remain very pleased with the continued strong performance of the US launch of Arikayce amikacin liposome inhalation suspension. Insmed remains guided by our desire to have a positive impact on patients’ lives and is powered by our shared sense of purpose to deliver therapies to small patient populations experiencing big health problems. We are also progressing well with our global expansion efforts including filing for regulatory approval of Arikayce in the EU last quarter and advancing our planned regulatory filings in Japan in first half of 2020.”
Read the Insmed report.
