Common use of Phase 3 Clinical Program Clause in Contracts

Phase 3 Clinical Program. The Phase 3 study will be a non-inferiority trial versus Forteo® to be conducted in postmenopausal women with osteoporosis at risk of fracture. The Phase 3 study will be a randomized, double-blind study with a primary endpoint of proportion of patients with one or more new vertebral fractures. The tentative plan for this study is to assess a more convenient dosing regimen of BA058 (e.g. 4-6 months of daily SC injections) versus a 12-month treatment regimen with Forteo®. After completion of the study, an observational post-treatment follow up study will be conducted to assess whether patients continue to benefit from prior treatment with study medication. Title: Effects of BA058 in the Treatment of Postmenopausal Women with Osteoporosis Protocol Number: BA058-05-003 Title: Extended Follow-Up of Patients in BA058 Clinical Trials Protocol Number: BA058-05-004 The primary objective of the study is to: · Demonstrate a reduction in the proportion of patients with new vertebral fractures following treatment with study medication. The secondary objectives of the study are to: · Establish the safety of chronic administration of BA058 in postmenopausal women with osteoporosis. · Compare the effects of chronic administration of BA058 with calcium and vitamin D versus Forteo® with calcium and vitamin D on lumbar spine and hip BMD in postmenopausal women with osteoporosis. · Assess the effects of chronic administration of BA058 on biochemical markers of bone formation and resorption. · Assess the durability of response by following patients in a long-term post-study observational period. A total of 3200 eligible patients will be enrolled and randomized to one of the two treatments below: *Assumes a ratio of BA058: Forteo of 1:1.

Phase 3 Clinical Program. The Phase 3 study will be a non-inferiority trial versus Forteo® to be conducted in postmenopausal women with osteoporosis at risk of fracture. The Phase 3 study will be a randomized, double-blind study with a primary endpoint of proportion of patients with one or more new vertebral fractures. The tentative plan for this study is to assess a more convenient dosing regimen of BA058 (e.g. 4-6 months of daily SC injections) versus a 12-month treatment regimen with Forteo®. After completion of the study, an observational post-treatment follow up study will be conducted to assess whether patients continue to benefit from prior treatment with study medication. Title: Effects of BA058 in the Treatment of Postmenopausal Women with Osteoporosis Protocol Number: BA058-05-003 * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. Title: Extended Follow-Up of Patients in BA058 Clinical Trials Protocol Number: BA058-05-004 The primary objective of the study is to: · Demonstrate a reduction in the proportion of patients with new vertebral fractures following treatment with study medication. The secondary objectives of the study are to: · Establish the safety of chronic administration of BA058 in postmenopausal women with osteoporosis. · Compare the effects of chronic administration of BA058 with calcium and vitamin D versus Forteo® with calcium and vitamin D on lumbar spine and hip BMD in postmenopausal women with osteoporosis. · Assess the effects of chronic administration of BA058 on biochemical markers of bone formation and resorption. · Assess the durability of response by following patients in a long-term post-study observational period. A total of 3200 eligible patients will be enrolled and randomized to one of the two treatments below: *Assumes a ratio of BA058: Forteo of 1:1.