Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical
company focused on developing orphan treatments for rare pulmonary
diseases, today reported that three ARIKAYCE™ abstracts and three
INS1009 abstracts will be presented at the American Thoracic
Society (ATS) 2015 International Conference taking place in Denver
from May 15 – 20. ARIKAYCE, or liposomal amikacin for inhalation,
is in late-stage development for the treatment of adult patients
with nontuberculous mycobacterial (NTM) lung infections caused by
Mycobacterium avium complex (MAC). INS1009, an inhaled prodrug
formulation of treprostinil, is the company’s clinical candidate
for pulmonary arterial hypertension.
Summarized below are the poster titles and presentation times.
The ATS abstracts are available online at the conference website at
http://conference.thoracic.org/2015/.
Poster Session: Preclinical Trials in Pulmonary Hypertension
Models: Novel Targets and Delivery
Date: Sunday, May 17, 2015Session Time: 9:30 AM-4:15 PMPoster
Viewing: 11:30-1:15
Abstract Title: A 14-Day Assessment of the
Tolerability and Pharmacokinetics (Pk) with a Nanoparticle
Formulation of Hexadecyl-Treprostinil, a Long-Acting Pulmonary
Vasodilator, In RatsLead Author: V. Malinin, PhDPoster Board:
#P496Publication Number: A1948
Abstract Title: Prolonged Pharmacokinetic
Profile of a Prodrug Lipid Nanoparticle Formulation of Treprostinil
in DogsLead Author: F.G. Leifer, PhDPoster Board:
#P499Publication Number: A1951
Abstract Title: Effect of a Lipid
Nanoparticle Prodrug Formulation of Treprostinil on the Cough
Reflex in Guinea PigsLead Author: R.W. Chapman, PhDPoster
Board: #P500Publication Number: A1952
Poster Session: Diagnosis and Management of Nontuberculous
Mycobacteria Infections
Date: Wednesday, May 20, 2015Session Time: 1:30 PM-3:30 PMPoster
Viewing: 1:30-2:15
Abstract Title: Subgroup Analyses of
Baseline Demographics and Efficacy in Patients with Refractory
Nontuberculous Mycobacteria (NTM) Lung Infection Treated with
Liposomal Amikacin for Inhalation (LAI)Lead Author: K.L.
Winthrop, MDPoster Board: #610Publication Number: A6294
Abstract Title: Efficacy of Liposomal
Amikacin for Inhalation (LAI) in Achieving Nontuberculous
Mycobacteria (NTM) Culture Negativity in Patients Whose Lung
Infection is Refractory to Guideline-Based TherapyLead Author:
J.A. Biller, MDPoster Board: #611Publication Number: A6295
Abstract Title: Analysis of Functional
Exercise Capacity (Via the Six-Minute Walk Test [6MWT]) and Culture
Negativity in Patients with Nontuberculous Mycobacteria (NTM) Lung
Infection Refractory to Guideline-Based Therapy Treated with
Liposomal Amikacin for Inhalation (LAI)Lead Author: S.J. Ruoss,
MDPoster Board: #612Publication Number: A6296
About ARIKAYCE
ARIKAYCE 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.
About eFlow® Technology and PARI Pharma
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.
About Nontuberculous Mycobacteria (NTM)
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.
NTM lung disease is often a chronic condition that can lead to
progressive inflammation and lung damage, and is characterized by
bronchiectasis and cavitary disease. NTM infections often require
lengthy hospital stays for medical management. Treatment usually
involves multi-drug regimens that can be poorly tolerated and have
limited effectiveness, especially in patients with severe disease
or in those who have failed prior treatment attempts. According to
a company-sponsored patient chart study conducted by Clarity Pharma
Research, approximately 50,000 patients suffering from NTM lung
disease visited physician offices in the U.S. during 2011.
About INS1009
INS1009, the company’s inhaled treprostinil prodrug 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 INS1009 with the goal of
addressing current limitations of inhaled prostacyclin therapies in
the treatment of PAH. INS1009 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.
About Pulmonary Arterial Hypertension (PAH)
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. In PAH, the pulmonary arteries constrict
abnormally. This forces the heart to pump harder to maintain
adequate blood flow, which causes blood pressure within the lungs
to rise. Common early symptoms include shortness of breath,
fatigue, weakness, chest pain and syncope (fainting), particularly
during physical activity. PAH worsens over time and is
life-threatening because the pressure in a patient's pulmonary
arteries rises to dangerously high levels, which strains the heart
and may lead to heart failure. The one-year mortality rate
among patients with PAH is 15% despite currently available
treatments. The cause of some cases of PAH is unknown and there is
no cure. PAH is considered an orphan disease, afflicting 30,000 to
40,000 people in the U.S. and 200,000 people globally.
There are several prescription medications approved by the U.S.
Food and Drug Administration (FDA) to treat the symptoms of PAH and
patients typically are treated with combination therapy including
endothelin receptor antagonists, PDE-5 inhibitors and prostacyclin
agonists. With annual sales exceeding $1 billion, prostacyclins are
the preferred choice for treating late-stage disease. Prostacyclin
formulations used to treat PAH include oral, intravenous,
subcutaneous and inhaled formulations. All existing prostacyclin
compounds have the limitation of a short half-life in the body and
require multiple dosing sessions per day for inhaled and oral
formulations, or the invasiveness of continuous infusion for
injectable formulations.
About Insmed
Insmed Incorporated is a biopharmaceutical company dedicated to
improving the lives of patients battling serious lung diseases.
Insmed is focused on the development and commercialization of
ARIKAYCE, or liposomal amikacin for inhalation, for at least two
identified orphan patient populations: patients with nontuberculous
mycobacteria (NTM) lung infections and cystic fibrosis (CF)
patients with Pseudomonas aeruginosa lung infections. Insmed is
also focused on the development of INS1009, the company’s inhaled
treprostinil prodrug 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 Incorporated:Susan Mesco, 908-947-4326Head of
Investor Relations
Insmed (NASDAQ:INSM)
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