Insmed Incorporated Appoints Myrtle Potter to the Board of Directors
Dec 15 14
Insmed Incorporated announced the appointment of Myrtle Potter to its Board of Directors. Ms. Potter is currently CEO of Myrtle Potter & Company. Ms. Potter serves as a Director of Liberty Mutual Holding Company, Rite Aid, Everyday Health and Proteus Digital Health, and as a Trustee of The University of Chicago.
Insmed Incorporated Provides Regulatory and Clinical Update on its Development Programs
Dec 15 14
Insmed Incorporated provided a regulatory and clinical update on the company's development programs. Insmed has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and is awaiting its validation. The Company has been informed by the EMA that the remaining item to be addressed prior to validation is the approval of the Pediatric Investigation Plan (PIP) by the EMA's Pediatric Committee, which is expected to be completed in the first quarter of 2015. Insmed's phase 3 pivotal trial for patients with treatment resistant nontuberculous mycobacteria (NTM) lung infections (the 212 trial) is on track. The protocol has been agreed upon following dialogue with the U.S. Food and Drug Administration (FDA) and the U.S. central Institutional Review Board (IRB) submission is complete. The company expects to begin screening patients no later than January 2015, as previously indicated. Insmed has completed a pre-investigational new drug (IND) meeting with the FDA for INS-1009, its novel formulation of a proven prostacyclin therapy for the treatment of Pulmonary Arterial Hypertension (PAH) and has clarified that, subject to final review of the pre-clinical data, it would be eligible for a 505(b)(2) approval pathway. ARIKAYCETM is a form of the antibiotic amikacin, which is enclosed in nanocapsules of lipid called liposomes. This advanced pulmonary liposome technology prolongs the release of amikacin in the lungs while minimizing systemic exposure. The treatment uses biocompatible lipids endogenous to the lung that are formulated into small (0.3 micron), charge-neutral liposomes. ARIKAYCE is administered once-daily using an optimized, investigational eFlow Nebulizer System manufactured by PARI Pharma GmbH, a novel, highly efficient and portable aerosol delivery system. ARIKAYCE is delivered by an investigational eFlow Nebulizer System developed by PARI Pharma and optimized specifically for ARIKAYCE. The optimized device uses eFlow Technology to enable highly efficient aerosolization of medication including liposomal formulations via a vibrating, perforated membrane that includes thousands of laser-drilled holes. Compared with other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size and a high proportion of respirable droplets delivered in the shortest possible period of time. eFlow Technology is not an ultrasonic nebulizer technology and is not a general purpose electronic aerosol generator nebulizer technology. Combined with its quiet mode of operation, small size, light weight and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments. Nontuberculous mycobacteria (NTM) are organisms found in the soil and water that can cause serious lung disease in susceptible individuals, for which there are currently limited effective treatments and no approved therapies. The prevalence of NTM disease is reported to be increasing, and according to reports from the American Thoracic Society is believed to be greater than that of tuberculosis in the U.S. According to the National Center for Biotechnology Information, epidemiological studies show that presence of NTM infection is increasing in developing countries, perhaps because of the implementation of tap water. Women with characteristic phenotype are believed to be at higher risk of acquiring NTM infection along with patients with defects on cystic fibrosis transmembrane conductance regulators. INS-1009 (treprostinil), the company's novel inhalation formulation of a proven prostacyclin for the treatment of pulmonary arterial hypertension (PAH), a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs. Insmed has applied its product design, drug development and sustained-release formulation expertise to advance INS-1009 with the goal of addressing current limitations of inhaled prostacyclin therapies in the treatment of PAH. INS-1009 is expected to be delivered once-daily via inhalation. It is designed to provide consistent, effective drug levels and may also reduce the acute systemic effects of current treatment options. Pulmonary arterial hypertension, or PAH, is a chronic, life-threatening form of pulmonary hypertension that is characterized by abnormally high blood pressure in the arteries between the heart and lungs. Pulmonary arteries carry blood from the heart to the lungs, where it picks up oxygen to be delivered throughout the body.
Insmed Incorporated Presents at 26th Annual Piper Jaffray Healthcare Conference, Dec-02-2014 01:30 PM
Nov 26 14
Insmed Incorporated Presents at 26th Annual Piper Jaffray Healthcare Conference, Dec-02-2014 01:30 PM. Venue: The New York Palace Hotel, 455 Madison Ave, New York, NY 10022, United States. Speakers: William H. Lewis, Chief Executive Officer, President and Director.