European decentralised approval concluded for Steovess (Takeda) for Osteoporosis

Takeda Pharmaceuticals International GmbH announced that the European decentralised procedure was positively concluded for Steovess (formerly known as EX101), a once-a-week 70mg buffered effervescent alendronate for the treatment of Post-menopausal Osteoporosis. The Company submitted its application for marketing authorization in multiple countries through the DCP on 17 September 2010, with the United Kingdom (MHRA) serving as its Reference Member State (RMS). Following its evaluation, the RMS and all Concerned Member States (CMS) reached consensus that Steovess is approvable. The regulatory process will enter now into the national phase in which each of the member states shall adopt a national decision and grant national marketing authorizations. Pending those decisions, Takeda anticipates first launches in the second half of 2012. European approval will be used as the basis for submissions in key emerging markets. Takeda holds exclusive rights from EffRx Pharma, to develop, manufacture and commercialise the effervescent formulation of alendronate for the treatment of osteoporosis in all territories in the world except USA, Canada, and Japan