- Global Phase 3 ARIKAYCE™ study update. Patient enrollment continues in the company's global phase 3 study of ARIKAYCE (liposomal amikacin for inhalation or LAI) in nontuberculous mycobacteria (NTM) lung disease (CONVERT™ or INS-212 study). The company has secured health authority clearance in 12 countries with CONVERT study sites and 83 sites are open. Securing regulatory clearance for a few countries in
Asiaand Europehas taken longer than expected. In addition, while patient screening is going well at many sites, the ramp of enrollment at certain centers is slower than expected largely due to administrative delays. As a result, the company expects to achieve its enrollment objective six to 12 months later than its initial expectation of enrolling the study by the end of 2015. Insmedhas taken a number of steps to accelerate enrollment, including enhancing its clinical operations team with new talent.
- EMA regulatory review of ARIKAYCE is progressing. The company remains on track to submit its responses to the
European Medicine Agency's(EMA) 120-day questions before the end of 2015. The 120-day questions are part of EMA's review of the company's marketing authorization application (MAA) for ARIKAYCE.
- INS1009 advancing toward clinical development.
Insmedrecently submitted an Investigational New Drug (IND) application and remains on track to begin a phase 1 clinical study of INS1009 before the end of 2015. INS1009 is the company's nebulized treprostinil prodrug that is being developed as a treatment for pulmonary arterial hypertension (PAH).
- Management team enhancements. The company recently made key enhancements to its senior leadership team, including the recent hire of Reinilde Heyrman, MD, senior vice president, clinical operations and development, and the promotion of
Drayton Wiseto vice president of sales and marketing. Dr. Heyrmanwill have direct oversight over the development and registration-readiness of Insmed's pipeline. Dr. Heyrmanhas 24 years of global clinical development experience at companies such as Bellerophon Therapeutics, Ikaria, Inc.( Mallinckrodt Pharmaceuticals), Daiichi-Sankyo, and Pharmacia and Upjohn(Pfizer). Mr. Wisejoined Insmedin 2014 and previously worked at Novartis, where he led the U.S. sales launch of the TOBI Podhaler®, Novartis' leading inhaled antibiotic for cystic fibrosis patients.
- Patient-focused drug development meeting hosted by
U.S. Food and Drug Administration(FDA) for NTM lung disease highlights unmet medical need. As part of its patient-focused drug development program, the FDArecently conducted a public meeting for NTM lung disease in order to obtain patients' perspectives on the impact of NTM lung disease on daily life and treatment approaches. During the afternoon's scientific workshop, Insmedparticipated on a panel with academic experts and discussed the unique aspects of developing drugs to treat NTM lung disease.
"We are making important progress advancing our efforts to support the approval and commercial launch of ARIKAYCE," said
For the third quarter of 2015,
Research and development expenses were
General and administrative expenses for the third quarter of 2015 were
Balance Sheet Highlights and Cash Guidance
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