PARI Pharma's Altera Delivers Gilead's Cayston, Approved By The U.S. FDA For The Improvement Of Respiratory Symptoms In Cystic Fibrosis Patients

Main Category: Cystic Fibrosis
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 24 Feb 2010 - 3:00 PDT

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Altera, which uses eFlow Technology, was cleared to market by the FDA as the first drug-specific nebulizer for use in the treatment of patients with cystic fibrosis and has been specifically developed to deliver Gilead Sciences' Cayston (aztreonam for inhalation solution) 75 mg. Cayston is a new inhaled antibiotic that received marketing approval from the U.S. Food and Drug Administration (FDA) yesterday as a treatment to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa). The safety and efficacy of Cayston have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second (FEV(1)) of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.

"Cayston delivered with the Altera offers significant advances to cystic fibrosis patients, especially since this is the first new inhaled antibiotic approved for CF in the last 10 years. By optimizing the drug and the device together, we have a new therapy that has the potential to improve patient adherence through device portability and a significant reduction in treatment time," said Martin Knoch, president of PARI Pharma.

The pairing of Cayston and Altera is a key advance in drug and device optimization. PARI Pharma contributed to the approval of Cayston by optimizing the formulation for administration via a specifically customized nebulizer system (brand name Altera) based on eFlow Technology. Altera delivers Cayston in two to three minutes, as evidenced in multiple clinical trials.

"We are excited on behalf of the CF community, because the new Altera device allows patients to take an inhaled antibiotic in under three minutes," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. "This significantly reduces patients' overall treatment burden and increases their quality of life."

"I am very excited to see novel technology from PARI Pharma put to work for CF patients. The fact that Altera will deliver this therapy in two to three minutes changes the paradigm of inhaled treatments by nebulizer. CF patients typically perform a variety of nebulizer treatments that take hours a day. This impacts their daily lives, so it is important to see that researchers are working to improve not only new drugs but also new delivery devices," said Dr. Frank Accurso, professor of Pediatrics at the University of Colorado, Denver and Children's Hospital in Aurora, Colorado.

Cayston is administered at a dose of 75 mg three times daily over a 28-day period and is delivered via the Altera Nebulizer System, a portable, drug-specific delivery device using the eFlow Technology Platform. Cayston received conditional marketing authorizations in the European Union and Canada in September 2009 and was approved in Australia in January 2010.

About the Altera Nebulizer System and eFlow Technology

Cayston is only approved for use with the Altera Nebulizer System, which has been optimized specifically for Cayston. Altera Nebulizer Systems are consistent with the specifications of the customized nebulizer systems based on eFlow Technology that were used exclusively in all Cayston clinical trials. The Altera Nebulizer 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 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. The Altera Nebulizer 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. Chronic respiratory tract infection with P. aeruginosa contributes to the decline in pulmonary function, which is often associated with 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 near Munich, Germany with a major presence in the United States.

Source: PARI Pharma

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