Shire Pharmaceuticals Group announced that an agreement has been signed with Bayer giving them the exclusive rights to develop, market and sell Fosrenol (lanthanum carbonate) in Japan, the world's second largest pharmaceuticals market. Fosrenol is a non-aluminium, non-calcium-based phosphate binder under registration in the US and EU for hyperphosphataemia associated with End Stage Renal Disease (ESRD). Bayer will market the drug through its wholly owned subsidiary in Japan, Bayer Yakuhin Ltd.
Shire's strategy is to continue to build its direct presence in the world's largest pharmaceuticals market, the United States as well as in Europe and the company no longer intends to create its own dedicated business operation in Japan. Instead, Shire will pursue partnering arrangements in Japan.
The total potential value of the Fosrenol deal is in excess of US$70 million, including an up-front license fee of US$12.5 million, the payment of all development costs and the achievement of various development and sales milestones during the course of the agreement. Shire will also receive double-digit royalties. Fosrenol has completed Phase I development in Japan. Fosrenol is in registration in the EU and Shire has received an approvable letter for the drug from the US Food & Drug Administration.
It is estimated1 that in excess of 200,000 people in Japan suffer from ESRD. Shire chief executive Matthew Emmens says, "In Japan, the number of patients with ESRD, the main target for Fosrenol, approaches that of the US, making the market opportunity very attractive. Out-licensing Fosrenol is in line with our new strategy of focusing our direct operations in North America and Europe and finding complementary and experienced partners in other territories around the world.
"Bayer Yakuhin is a fully integrated pharmaceutical company headquartered in Osaka, Japan, with world-class clinical development and marketing capabilities, including almost 700 medical reps in Japan. Fosrenol will be an excellent strategic fit for Bayer Yakuhin, which already has an active programme to manage renovascular disease and expects to launch another major drug in Japan that will be sold in dialysis centers one year or more ahead of Fosrenol."