Indication. BA058 is indicated for the treatment of postmenopausal women with osteoporosis who are at high risk of fracture. BA058 is indicated to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk of fracture. Efficacy: Statistically equivalent or superior effect on BMD relative to Forteo®. Dosing: Significantly shortened dosing cycle to restore BMD (vs. 12+ months for Forteo®) when administered QD via subcutaneous administration. Alternatively, significantly shortened dosing schedule than once-daily (e.g. 3 times/week). Improved formulations that allow a significant advance in dosing convenience along with reduced pain. Safety: Absence of significant hypercalcemia with BA058 treatment.
Appears in 3 contracts
Samples: License Agreement (Radius Health, Inc.), License Agreement (Radius Health, Inc.), License Agreement (Radius Health, Inc.)
Indication. BA058 is indicated for the treatment of postmenopausal women with osteoporosis who are at high risk of fracture. BA058 is indicated to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk of fracture. Efficacy: Statistically equivalent or superior effect on BMD relative to Forteo®. Dosing: Significantly shortened dosing cycle to restore BMD (vs. 12+ months for Forteo®) when administered QD via subcutaneous administration. Alternatively, significantly shortened dosing schedule than once-daily (e.g. 3 times/week[*]/week). Improved formulations that allow a significant advance in dosing convenience along with reduced pain. Safety: Absence of significant hypercalcemia with BA058 treatment. * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission.
Appears in 1 contract
Indication. BA058 is indicated for the treatment of postmenopausal women with osteoporosis who are at high risk of fracture. BA058 is indicated to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk of fracture. Efficacy: Statistically equivalent or superior effect on BMD relative to Forteo®. Dosing: Significantly shortened dosing cycle to restore BMD (vs. 12+ months for Forteo®) when administered QD via subcutaneous administration. Alternatively, significantly shortened dosing schedule than once-daily (e.g. 3 times/week). Improved formulations that allow a significant advance in dosing convenience along with reduced pain. Safety: Absence of significant hypercalcemia with BA058 treatment. * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission.
Appears in 1 contract