Akela Pharma Inc, a drug development company focused on developing therapies for the inhalation and pain markets, announced that Finnish Regulatory Authorities have been the first one to grant approval to initiate a phase-3 clinical study with Fentanyl Taifun. Further approvals are expected in the near future.
This approval triggers the first in a series of three milestones to be paid by Janssen Pharmaceutica NV in relation to the initiation of the Fentanyl Taifun phase-3 programme. 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, announced the initiation of its clinical development program in Japan. Teikoku Seiyaku is now conducting phase-2 and phase-3 studies that are essentially similar to AKELA's European development program, amended to reflect local regulatory requirements and treatment practices.
Akela Pharma is an integrated drug development company focused on developing therapies for the growing multi-billion dollar inhalation and pain markets.