Updated on 1 July 2015
Advanced Accelerator Applications S.A. (AAA), France-based specialist in Molecular Nuclear Medicine (MNM), has entered into a distribution agreement for Lutathera in Japan with Fujifilm RI Pharma Co. LTD (FRI), a leading distributor of nuclear medicine and diagnostic imaging products in Japan.
Lutathera is indicated for the treatment of midgut neuro endocrine tumors and is currently in a pivotal Phase III trial in 51 clinical centers in the United States and EU.
As part of the agreement, AAA will receive launch and development milestone payments, in addition to royalties on product sales. Lutathera will be manufactured by AAA in Europe and sold to FRI by its subsidiary AAA International.
AAA and FRI will work together to meet all Japanese regulatory requirements and prepare for national approval.
Stefano Buono, Chief Executive Officer of AAA said, "FRI provides important sales, marketing and distribution capabilities for Lutathera in the Japanese market as well as providing the support needed to gain regulatory clearance in Japan. We believe Asia is a significant market for Lutathera, and Japan represents an important first presence as we introduce the product into the region. Our plans are to continue implementing selected distributorships such as our agreement with FRI, in countries where we have not planned a direct presence."
Gérard Ber, Chief Operating Officer of AAA, said, "Meeting an unmet medical need, with Lutathera for gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients around the world, is a key strategic objective of AAA. As we start developing the Lutathera franchise, we look forward to additional commercialization agreements for other countries and the ability to provide cancer patients with better care on an increasingly global scale."