Under the terms of the agreement, Endo will pay Alexza an upfront fee of $10 million, with additional payments of up to $40 million upon achievement of predetermined regulatory and clinical milestones. Endo will also pay undisclosed royalties to Alexza on net sales of the product, from which Alexza will pay for the cost of goods for the manufacture of commercial product. In the partnership, Alexza has primary responsibility for the development of the Staccato electronic multiple dose device and the exclusive right to manufacture the product for clinical development and commercial supply. Endo has primary responsibility for pre-clinical, clinical and regulatory development, and, if AZ0003 is approved for marketing, for commercializing the product in North America.
Currently in Phase I clinical development, AZ-003 is a hand-held drug device that uses Alexza’s proprietary Staccato system inhalation technology to deliver fentanyl for the treatment of breakthrough pain in cancer and non-cancer patients.
Thomas King, president and CEO of Alexza, said: “We believe Endo is an ideal partner for AZ-003. We look forward to working together with them to develop this important new technology and product for the opioid markets.”