In this section
Development of the clinical program aimed at NTM infections was done in partnership with the
No new drugs have been assessed for NTM in a significant number of years. The sustained-release formulation of ARIKACE allows for targeting of the drug to the lungs and the site of disease.
ARIKACE™ 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 that enable penetration of the biofilm. ARIKACE is administered once daily using an optimized, investigational eFlow® Nebulizer System (
ARIKACE has been granted orphan drug status in
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. NTM lung disease is often a chronic condition that can lead to progressive inflammation and lung damage, characterized by bronchiectasis and cavitary disease. NTM infections often require lengthy hospital stays for medical management. Treatment usually involves lengthy multi-drug regimens that can be poorly tolerated and with limited effectiveness, especially in patients with severe disease or in those who have failed prior treatment attempts. According to a proprietary SDI Healthcare Database, in the U.S. in 2008, there were approximately 32,000 patients who had a physician office visit for a primary diagnosis of NTM, and about 14,400 patients who had a hospital visit with an NTM diagnosis.
About eFlow® Technology and PARI Pharma
ARIKACE is delivered by an optimized, investigational eFlow® Nebulizer System developed by PARI Pharma and optimized specifically for ARIKACE. The optimized, investigational eFlow Nebulizer System 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 to 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 it 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. PARI Pharma focuses on the development of aerosol delivery devices and comprehensive inhalation drug development to advance aerosol therapies where drug and device can be optimized together. Online at www.paripharma.com.
This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to the results of clinical trials, the development of our products, or the business strategies, plans and objectives of management, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, we may be unsuccessful in developing our product candidates or receiving necessary regulatory approvals, we may experience delays in our product development or clinical trials, our product candidates may not prove to be commercially successful, our expenses may be higher than anticipated and other risks and challenges detailed in our filings with the