Astellas Pharma Inc. announced that it has terminated the License Agreement with Les Laboratoires Servier regarding the anti-osteoporosis agent FK481 (development code#, generic name: strontium ranelate), which Astellas in-licensed from Servier.
Strontium ranelate, generated by Servier, is an anti-osteoporosis agent decreasing bone resorption as well as increasing bone formation and has been launched overseas under the trademark "Protelos." Astellas obtained exclusive rights to develop, manufacture and market the product for the Japanese market in 2001 from Servier, and has engaged in development of strontium ranelate for the treatment of osteoporosis in Japan.
The phase-II trials in Japan indicated an excellent efficacy and safety profile of strontium ranelate, equivalent to European Studies results. As a result of re-evaluation of the priority of its current development pipeline coupled with economic feasibility, however, Astellas has decided to withdraw from the further development of strontium ranelate in Japan. Thus, Astellas has terminated the License Agreement with Servier regarding the development, manufacturing and marketing of strontium ranelate in Japan.