Ono Pharmaceutical Co., Ltd. and Astellas Pharma Inc. announced the launch of Recalbon tablets 50mg (Ono) /Bonoteo tablets 50mg (Astellas) (generic name: Minodronic Acid Hydrate) in Japan on September 16, 2011. The once-per-four-week oral drug has been jointly developed by the two companies for the treatment of osteoporosis and its Japanese marketing approval was granted on July 1, 2011.
Minodronic acid hydrate is an oral bisphosphonate that has been discovered by Astellas and has been co-developed by Ono and Astellas. This drug increases bone mineral density and strength by inhibiting osteoclastic bone resorption. Recalbon tablets 1mg /Bonoteo tablets 1mg, a once-a-day formulation of this drug, demonstrated significant efficacy in bone fractures prevention and was launched in Japan during April 2009.
In a phase 2/3 study in Japan, Recalbon tablets 50mg / Bonoteo tablets 50mg, once –per-four-week formulation of this drug, demonstrated non-inferiority to the daily formulation 1 mg in average bone mineral density change in lumbar spines, the primary endpoint. Furthermore, in the safety evaluation of the phase 2/3 study, once-per-four-week formulation 50 mg appeared to be safe, while the incidence of side-effects was low and comparable to the 1mg daily formulation. Based on the results of the study, the once-per-four-week Recalbon tablets 50mg /Bonoteo tablets 50mg has an equivalent effect in bone fractures prevention to the daily formulation and improves the patient’s convenience by reducing the dose frequency.
Since the launch of Recalbon tablets 1mg / Bonoteo tablets 1mg in Japan, Ono and Astellas have contributed to the improvement of the quality of life for patients suffering from osteoporosis through the prevention of bone fractures. Both companies expect that the once-per-four-week Recalbon tablets 50mg / Bonoteo tablets 50mg will provide a new therapeutic option to the current osteoporosis treatment in addition to Recalbon tablets 1mg / Bonoteo tablets 1mg, and expect the tablets to contribute further to patients’ wellbeing.
Both companies anticipate that peak sales of Recalbon and Bonoteo 50mg/1mg altogether may reach 32.0 billion yen(based on NHI drug price)in FY2015.