- Global Phase 3 ARIKAYCE™ study advancing. 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 caused by Mycobacterium avium complex (MAC) (CONVERT™ or INS-212 study). The CONVERT study is taking place in 16 countries and more than 115 sites. The company continues to expect to achieve its enrollment objective in the second half of 2016.
- EMA regulatory review of ARIKAYCE progressing. The company submitted its responses to the
European Medicine Agency's(EMA) Committee for Medicinal Productsfor Human Use (CHMP) 120-day questions in December 2015and expects to receive the CHMP's 180-day list of outstanding issues (LOI) in the first quarter of 2016. Insmedanticipates responding to the LOI and participating in an oral hearing with the CHMP in the second quarter of 2016 to address the LOI on the company's marketing authorization application (MAA) for ARIKAYCE. The company continues to expect the CHMP to render an opinion on its MAA around the middle of 2016.
- Phase 1 clinical study of INS1009 underway.
Insmedis conducting a phase 1 study of INS1009 in healthy subjects. INS1009 is the company's nebulized treprostinil prodrug. The company believes INS1009 may offer a differentiated product profile with therapeutic potential in rare pulmonary disorders such as pulmonary arterial hypertension (PAH), idiopathic pulmonary fibrosis (IPF), sarcoidosis, and severe refractory asthma.
- INS1009 patent issued. The
U.S.patent and trademark office issued U.S.patent no. 9,255,064 (the '064 patent) on February 9, 2016. The ‘064 patent, entitled "Prostacyclin compounds, compositions and methods of use thereof" is the first patent to issue with claims reciting INS1009. Other treprostinil prodrugs are also claimed and described in the patent. Methods of using treprostinil prodrugs, including INS1009, are described in the patent. The ‘064 patent provides exclusivity for INS1009 until October 24, 2034.
Fourth Quarter Financial Results
For the fourth quarter of 2015,
Research and development expenses were
General and administrative expenses for the fourth quarter of 2015 were
Balance Sheet Highlights and Cash Guidance
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