Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Akela Pharma, an integrated drug development company, has announced that Finnish regulatory authorities have granted approval to initiate a Phase III clinical study with Fentanyl Taifun. Further approvals are expected in the near future.
Subscribe to our email newsletter
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.