MOUNTAIN VIEW, Calif., Feb. 22 /PRNewswire-FirstCall/ -- Aerogen, Inc. today announced that it has received Fast Track Designation from the U.S. FDA for the Combination Product: Amikacin Pulmonary Delivery System for Ventilator-Associated Pneumonia (VAP). The product is Aerogen's lead drug/device combination product incorporating Aerogen's OnQ(R) Aerosol Generator technology adapted for high efficiency aerosol delivery to patients on mechanical ventilators.
The Fast Track Designation program was created to facilitate the development and expedite the review of a new product that is intended for the treatment of serious or life-threatening conditions, and demonstrates the potential to address unmet medical needs for such conditions. The FDA stated that it granted Combination Product: Amikacin Pulmonary Delivery System Fast Track designation for the following reasons:
1. VAP is a significant cause of morbidity and mortality in the intensive
care unit (ICU), with an associated mortality rate of up to 50%.
Patients with VAP have significantly longer duration of mechanical
ventilation, ICU stay and hospital stay.
2. While Gram-negative organisms associated with VAP can be treated with
aminoglycosides intravenously, parenteral delivery results in poor
penetration of drug into the respiratory secretions and can cause
significant adverse systemic effects. Targeted delivery of amikacin
directly to the lungs takes advantage of the concentration-dependent
killing of aminoglycoside antibiotics and has the potential to hasten
resolution of the infection. The combination of high antibiotic
concentrations at the infection site with low serum levels offers the
possibility of reducing systemic toxicity.
"We are excited about the potential to significantly improve the treatment of patients with VAP using Aerogen's aerosolized amikacin product and are delighted with FDA's decision to grant Fast Track Designation for our program," said Dr. Robert Fishman, Vice President of Scientific Affairs.
Aerogen, a specialty pharmaceutical company, develops products based on its OnQ Aerosol Generator technology to improve the treatment of respiratory disorders in the acute care setting. Aerogen has presented the results of its first Phase 2 clinical study evaluating delivery of aerosolized amikacin for the treatment of ventilator-associated pneumonia; an additional Phase 2 study is currently underway. Following amikacin, additional drug products targeting improved respiratory therapy in the acute care setting are in the feasibility and pre-clinical stages of development. Aerogen's Aeroneb(R) Professional Nebulizer System is marketed world-wide for use in hospitals. Aerogen's Aeroneb(R) Go Nebulizer for home use is currently marketed in the U.S., Japan and certain European countries. Aerogen also has development collaborations with pharmaceutical and biotechnology companies for use of its technology in the delivery of novel compounds that treat respiratory and other disorders. Aerogen is headquartered in Mountain View, California, with a campus in Galway, Ireland. For more information, visit http://www.aerogen.com/.
To the extent any statements made in this release relate to information that is not historical, these statements are necessarily forward-looking. As such, they are subject to the occurrence of many events outside of Aerogen's control and other uncertainties, and are subject to various risk factors that could cause Aerogen's actual results to differ materially from those expressed in any forward-looking statement. The risk factors include, without limitation, the need for additional funding, the inherent risks of product development, clinical outcomes, regulatory risks and risks related to proprietary rights, market acceptance and competition, and are described in Aerogen's reports and other filings with the U.S. Securities and Exchange Commission, including Aerogen's Annual Report on Form 10-K for the year ended December 31, 2003, filed with the Securities and Exchange Commission ("SEC") on April 14, 2004 and Aerogen's Quarterly Report filed on Form 10-Q for the quarter ended September 30, 2004 filed with the SEC on November 15, 2004. Aerogen does not undertake any obligation to update forward-looking statements.