In its announcement of fourth quarter and full year financial results for 2014, Insmed has confirmed that it filed an MAA for Arikayce liposomal amikacin inhalation solution. The company said that the EMA’s Pediatric Committee has approved the Pediatric Investigation Plan for the product, and the MAA has subsequently been validated.
Insmed also announced the appointments of Olaf Bartsch as VP, Europe – General Manager, Germany and Francois Cornu as VP, Europe – General Manager, France. In addition, according to the announcement, the company has partnered with the European Respiratory Society to establish the ERS Research Award: Innovation in Non-Tuberculous Mycobacteria Science and Medicine.
The company’s net loss for 2014 increased to $79.2 million compared to $56.1 million for the 2013 fiscal year, and R&D expenses increased to $56.3 million in 2014 from $44.3 million in 2013. In August 2014, Insmed announced a stock offering to fund continued development and commercialization of Arikayce.
Insmed President and CEO Will Lewis commented, “We remain focused on our primary goal of advancing the 212 trial, our global phase 3 study in NTM patients who failed prior standard-of-care treatment. We have activated multiple sites and we continue to expect preliminary top-line clinical results in mid-2016. We are also pleased with our progress in Europe on several fronts. The validation of our MAA filing with the EMA starts the formal review process for Arikayce, the hiring of Drs. Bartsch and Cornu to lead our operations and the partnership with ERS show our commitment to bringing Arikayce to patients with NTM lung disease and to CF patients with pseudomonas lung infections. Finally, we are encouraged by the progress we have made with INS1009 treprostinil prodrug for the treatment of pulmonary arterial hypertension (PAH), which remains on track for an investigational new drug (IND) filing and the initiation of a phase 1 clinical trial later this year.”
Read the Insmed press release.
