This approval triggers the first in a series of three milestones to be paid by Janssen Pharmaceutica in relation to the initiation of the Fentanyl Taifun Phase III program. Janssen Pharmaceutica is the licensee for the product in Europe, Canada, Middle East and Africa.
At the same time Akela’s development and commercialization partner in Japan, Teikoku Seiyaku, has initiated its clinical development program in Japan.
Teikoku Seiyaku is now conducting Phase II and Phase III studies that are essentially similar to Akela’s European development program, amended to reflect local regulatory requirements and treatment practices.