NewsWednesday, 23. September 2009
PARI’s Altera Delivers Gilead’s Cayston, Approved by European Commission to Treat Cystic Fibrosis
Cayston, aztreonam lysine 75 mg powder and solvent for nebuliser solution, is a new antibiotic that received conditional marketing approval from the European Commission as a suppressive therapy for cystic fibrosis patients, 18 years and older, who have chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) infection.
The pairing of Cayston and Altera is a significant advance in drug and device optimization. PARI Pharma contributed to the development of Cayston’s drug formulation by optimizing the formulation for administration via a specifically customized nebuliser system based on eFlow Technology (trade name: Altera). Altera delivers Cayston in two to three minutes, as evidenced in multiple clinical trials, whereas other first-line therapies require 15 to 30-minute treatment times per dose.
"We are extremely pleased that Cayston has been approved by the European Commission and that the Altera Nebuliser System will be used to deliver the drug. Altera and Cayston offer significant advances to cystic fibrosis patients that speak to the future of nebulised drug delivery. Treatments under three minutes, with strong safety and efficacy, can only be achieved by optimizing the drug formulation and device together. It is worth taking the time and effort to develop such advanced inhaled therapies when you see the difference it can make in patients’ lives," said Martin Knoch, president of PARI Pharma.
Cayston is approved only for use with the Altera Nebuliser System or with the Altera Nebuliser Handset (including the Altera Aerosol Head) connected to a universal eFlow Technology controller (e.g. eBase Controller or eFlow rapid Control Unit). Altera Nebuliser Systems and Handsets will be made available in certain countries of the European Union, subject to the requirements of national approval for Cayston, beginning early 2010.
About the Altera Nebuliser System and
Cayston is delivered via the Altera Nebuliser System, which has been optimized specifically for Cayston. Altera Nebuliser Systems are consistent with the specifications of the customized nebuliser systems based on eFlow Technology that were used exclusively in all Cayston clinical trials. The Altera Nebuliser System uses eFlow Technology to enable highly efficient aerosolization of medication via a vibrating, perforated membrane that includes thousands of small holes producing the aerosol mist. Compared to other nebulisation 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. Combined with its quiet mode of operation, small size (it fits in the palm of the patient’s hand), light weight, and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments. The Altera Nebuliser System and eFlow Technology are proprietary to PARI Pharma.
About Cystic Fibrosis
CF is a chronic, debilitating genetic disease. A major characteristic of CF is production of abnormally thick, sticky mucus in the lungs, trapping bacteria and predisposing patients to lung infections, which continually damage their lungs.
Pulmonary infection with Gram-negative bacteria, particularly pulmonary P. aeruginosa, represents the single greatest cause of morbidity and mortality among CF patients. Currently there is no known cure for CF, and the goal of CF therapy is to control symptoms and prevent further lung damage.
About PARI Pharma
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. Based on PARI’s 100-year history working with aerosols, PARI Pharma develops treatments for pulmonary and nasal administration customized with advanced delivery platforms, such as eFlow (lower respiratory) and Vibrent (upper respiratory) Technologies. PARI Pharma partners with pharmaceutical companies to develop new or improved therapies. PARI Pharma has several clinical development programs ongoing, either partnered or on its own, for cystic fibrosis, asthma, COPD, respiratory syncytial virus (RSV) infection, and treatments for lung transplant patients among other indications. PARI Pharma, a PARI Medical Holding company, is located in Munich, Germany with a major presence in the United States. Online at www.paripharma.com
Additional information on eFlow is available by contacting Kirsten Ayars at 805-452-7909 or Geoff Hunziker at 831-372-3580 in the United States or Andreas Schmitt at +49 (0)89 742846-55 in Europe.