Most recently Amgen (NASDAQ: AMGN) announced the second successful Phase III trial for Denosumab (manufactured in Longmont, CO) osteoporosis study, which met all of its primary and secondary bone mineral density (BMD) endpoints in a head-to-head comparison with Merck’s (NYSE: MRK) Fosamax® in post menopausal women. Back in December of ‘07 CLSDF set the Amgen-Denosumab table, read more (here).
In this second study, Denosumab treatment achieved significantly greater BMD gains at the total hip, hip trochanter and distal radius compared with Fosamax®. For the primary endpoint, the relative magnitude of BMD improvement at the total hip was approximately 40% greater in the Denosumab versus the Fosamax® group.
With two trials down there are five ongoing active Phase III trials:
- A Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects with Low Bone Mineral Density
- A Pilot MicroCT Study to Estimate the Effect of Treatment with Denosumab and Fosamax® in Postmenopausal Women with Low Bone Mineral Density
- A Study to Evaluate Safety and Efficacy of Transitioning Therapy from Fosamax® to Denosumab in Postmenopausal Women With Low Bone Mineral Density
- A Study to Evaluate Denosumab in the Prevention of Postmenopausal Osteoporosis
- A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months)
- A Study to Evaluate the Adherence, Preference, and Satisfaction of Denosumab and Fosamax in Postmenopausal Women with Low Bone Mineral Density
- A Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab in the Treatment of Postmenopausal Osteoporosis
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