MOUNTAIN VIEW, Calif., Nov. 8 /PRNewswire-FirstCall/ -- Aerogen, Inc. announced today that it has submitted an Investigational New Drug Application ("IND") to the U.S. Food and Drug Administration to begin a second Phase 2 study of its aerosolized antibiotic product in patients with ventilator-associated pneumonia ("VAP"). The IND is for Aerogen's proprietary drug/device combination product, which delivers a targeted dose of amikacin to the lungs of patients on mechanical ventilation. The IND contains the protocol for conduct of the Phase 2 study to be conducted in over 100 patients; this study is designed to define the effective dose of antibiotic and monitor the clinical response in patients with confirmed VAP.
"Aerogen's VAP program exemplifies our commitment to improving therapeutic options for patients in the critical care setting. We expect to initiate enrollment of this multi-center international study by the end of this year, with results targeted to be available by the third quarter of 2005," said Robert Fishman, M.D., Aerogen Vice President of Scientific Affairs.
Aerogen has completed a Phase 2 clinical study in Tours, France; results confirmed the superior efficiency of Aerogen's proprietary aerosolized technology in safely delivering amikacin to the lungs of patients on mechanical ventilation. These data were presented at the American Thoracic Society Conference in Orlando, Florida in May 2004.
Aerogen, a specialty pharmaceutical company, develops products based on its OnQ(TM) Aerosol Generator technology to improve the treatment of respiratory disorders in the acute care setting. Aerogen currently markets the Aeroneb(R) Professional Nebulizer System for use in hospitals. Following amikacin, additional drug products targeting improved respiratory therapy in the acute care setting are in the feasibility and pre-clinical stages of development. In the U.S., Aerogen has commercialized the Aeroneb(R) Go Nebulizer for home use through its commercial partner, Evo Medical Solutions, Inc. 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 the Company's control and other uncertainties, and are subject to various risk factors that could cause the Company'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 the Company's reports and other filings with the U.S. Securities and Exchange Commission, including its 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 its 424b(3) prospectus filed with the SEC on August 17, 2004. Aerogen does not undertake any obligation to update forward-looking statements.