THOUSAND OAKS, CA, USA and BRUSSELS, Belgium I April 1, 2017 I Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced results from the fourth year of a Phase 2 study showing the efficacy and safety of a second course of treatment with EVENITY™* (romosozumab), an investigational agent for postmenopausal women with osteoporosis. The results were presented in an oral session (OR08-1) at ENDO 2017, the Endocrine Society’s Annual Meeting in Orlando, Fla.
In the study, postmenopausal women with low bone mass (lumbar spine, total hip or femoral neck T score between -2.0 and -3.5) were initially randomized to various doses of EVENITY or placebo for 24 months and then re-randomized to receive denosumab (Prolia®) or placebo for the next 12 months (24 to 36 months), as previously reported. For months 36 to 48, all of these patients were then treated with EVENITY (210 mg) for 12 months.
In patients who initially received 210 mg of EVENITY followed by placebo and then a second course of EVENITY (n=19), the second course led to significant increases in bone mineral density (BMD) to an extent similar to the initial EVENITY treatment: lumbar spine (12.7 percent), total hip (5.8 percent) and femoral neck (6.3 percent) during months 36 to 48. In those patients who received a second course of EVENITY after denosumab, EVENITY further increased BMD by 2.8 percent at the lumbar spine, while maintaining BMD at the total hip and femoral neck.
“Since osteoporosis is a chronic condition, which may lead to debilitating fractures, the option of providing a second course of bone-building therapy may benefit some patients with severe osteoporosis,” said David L. Kendler, M.D., University of British Columbia, Vancouver, Canada and lead study investigator. “This latest study is important as it shows that the safety and efficacy of romosozumab extends from initial use to a second course of treatment.”
A similar adverse event (AE) profile was observed in the EVENITY groups, regardless of prior treatment group (placebo or denosumab). In patients treated with EVENITY for months 36 to 48, serious AEs were reported for five percent of patients who initially received EVENITY (n=7/140) and four percent who initially received placebo (n=1/27). The AEs reported by these patients for months 36 to 48 include hypersensitivity (7.4 percent, initial placebo; 7.9 percent, initial EVENITY), injection-site reactions (7.4 percent, initial placebo; 7.1 percent, initial EVENITY), malignancies (3.7 percent, initial placebo; 3.6 percent, initial EVENITY) and osteoarthritis (11.1 percent, initial placebo; 2.1 percent, initial EVENITY). There were no reports of osteonecrosis of the jaw or atypical femoral fracture.
In the same oral session, Amgen and UCB presented results from a separate analysis of the Phase 2 study (OR08-2) showing BMD gains from prior EVENITY treatment were generally maintained for two years (months 48 to 72) when followed by a single dose of zoledronic acid.
The pivotal romosozumab Phase 3 studies have all been designed with patients receiving 12 months (single course) of romosozumab followed by treatment with an anti-resorptive therapy such as denosumab.
About EVENITY™* (romosozumab)
EVENITY is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the activity of sclerostin and has a dual effect on bone, increasing bone formation and decreasing bone resorption. EVENITY is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program includes two large fracture trials comparing EVENITY to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.
About Prolia® (denosumab)
Prolia® is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia® reduces the incidence of vertebral, nonvertebral, and hip fractures.
Prolia® is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
Prolia® is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Prolia® also reduced the incidence of vertebral fractures.
Prolia® is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
About the Amgen and UCB Collaboration
Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop and market antibody products targeting the protein sclerostin. As part of this agreement, the two companies continue to collaborate on the development of EVENITY* (romosozumab) for the treatment of osteoporosis. This gene-to-drug project demonstrates how Amgen and UCB are joining forces to translate a genetic discovery into a new medicine, turning conceptual science into a reality.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7,700 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
SOURCE: Amgen
Post Views: 23
THOUSAND OAKS, CA, USA and BRUSSELS, Belgium I April 1, 2017 I Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced results from the fourth year of a Phase 2 study showing the efficacy and safety of a second course of treatment with EVENITY™* (romosozumab), an investigational agent for postmenopausal women with osteoporosis. The results were presented in an oral session (OR08-1) at ENDO 2017, the Endocrine Society’s Annual Meeting in Orlando, Fla.
In the study, postmenopausal women with low bone mass (lumbar spine, total hip or femoral neck T score between -2.0 and -3.5) were initially randomized to various doses of EVENITY or placebo for 24 months and then re-randomized to receive denosumab (Prolia®) or placebo for the next 12 months (24 to 36 months), as previously reported. For months 36 to 48, all of these patients were then treated with EVENITY (210 mg) for 12 months.
In patients who initially received 210 mg of EVENITY followed by placebo and then a second course of EVENITY (n=19), the second course led to significant increases in bone mineral density (BMD) to an extent similar to the initial EVENITY treatment: lumbar spine (12.7 percent), total hip (5.8 percent) and femoral neck (6.3 percent) during months 36 to 48. In those patients who received a second course of EVENITY after denosumab, EVENITY further increased BMD by 2.8 percent at the lumbar spine, while maintaining BMD at the total hip and femoral neck.
“Since osteoporosis is a chronic condition, which may lead to debilitating fractures, the option of providing a second course of bone-building therapy may benefit some patients with severe osteoporosis,” said David L. Kendler, M.D., University of British Columbia, Vancouver, Canada and lead study investigator. “This latest study is important as it shows that the safety and efficacy of romosozumab extends from initial use to a second course of treatment.”
A similar adverse event (AE) profile was observed in the EVENITY groups, regardless of prior treatment group (placebo or denosumab). In patients treated with EVENITY for months 36 to 48, serious AEs were reported for five percent of patients who initially received EVENITY (n=7/140) and four percent who initially received placebo (n=1/27). The AEs reported by these patients for months 36 to 48 include hypersensitivity (7.4 percent, initial placebo; 7.9 percent, initial EVENITY), injection-site reactions (7.4 percent, initial placebo; 7.1 percent, initial EVENITY), malignancies (3.7 percent, initial placebo; 3.6 percent, initial EVENITY) and osteoarthritis (11.1 percent, initial placebo; 2.1 percent, initial EVENITY). There were no reports of osteonecrosis of the jaw or atypical femoral fracture.
In the same oral session, Amgen and UCB presented results from a separate analysis of the Phase 2 study (OR08-2) showing BMD gains from prior EVENITY treatment were generally maintained for two years (months 48 to 72) when followed by a single dose of zoledronic acid.
The pivotal romosozumab Phase 3 studies have all been designed with patients receiving 12 months (single course) of romosozumab followed by treatment with an anti-resorptive therapy such as denosumab.
About EVENITY™* (romosozumab)
EVENITY is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the activity of sclerostin and has a dual effect on bone, increasing bone formation and decreasing bone resorption. EVENITY is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program includes two large fracture trials comparing EVENITY to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.
About Prolia® (denosumab)
Prolia® is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia® reduces the incidence of vertebral, nonvertebral, and hip fractures.
Prolia® is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
Prolia® is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Prolia® also reduced the incidence of vertebral fractures.
Prolia® is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
About the Amgen and UCB Collaboration
Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop and market antibody products targeting the protein sclerostin. As part of this agreement, the two companies continue to collaborate on the development of EVENITY* (romosozumab) for the treatment of osteoporosis. This gene-to-drug project demonstrates how Amgen and UCB are joining forces to translate a genetic discovery into a new medicine, turning conceptual science into a reality.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7,700 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
SOURCE: Amgen
Post Views: 23
