AAA has entered into a distribution agreement for Lutathera in Japan with FUJIFILM RI Pharma, Co., LTD («FRI»), a leading in-country distributor of nuclear medicine and diagnostic imaging products. Lutathera is currently in a pivotal Phase III trial, both in the US and EU, with results expected in Q3.
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.
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 by its subsidiary AAA International to FRI.
In Europe’s five key markets and the US, AAA’s plan is to build complete and dedicated commercial structures in each country to support the launch and promotion of Lutathera and Somakit, Lutathera’s companion diagnostic, for which a New Drug Application (NDA) will soon be submitted to the FDA. Our plans are to continue implementing selected distributorships such as our agreement with FRI, in countries where we have not planned a direct presence.