CHADDS FORD, Pa. Endo Pharmaceuticals Holdings, a drug company focused on pain management, said Thursday it signed an agreement with Alexza Pharmaceuticals to develop and bring to market Alexza's early-stage inhaled pain treatment candidate AZ-003.
Currently in Phase I clinical development, AZ-003 is a hand-held, multiple-dose inhaler designed to deliver fentanyl, a pain reliever, into the lungs. Alexza's Staccato system vaporizes fentanyl to form a condensation aerosol that quickly gets into a patient's system through inhalation. The drug device system is designed to treat breakthrough pain—pain that does not respond to other therapies.
"Early clinical data suggest that AZ-003 could potentially have a rapid onset of action comparable to intravenous administration," said Endo president and chief executive Peter Lankau.
Alexza will manufacture the product for Endo and be responsible for completing development of the device. Under terms of the agreement, Endo will pay Alexza an upfront fee of $10 million, with additional payments of about $40 million upon achievement of predetermined regulatory milestones. Endo will also pay undisclosed royalties to Alexza on sales of AZ-003.