Prolia(R) (Denosumab) Granted Marketing Authorization in the European Union
Amgen Inc. (Nasdaq: AMGN) announced that the European Commission (EC) has granted marketing authorization for Prolia(R) (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. Prolia has been approved in all 27 European Union member states plus Norway, Iceland and Liechtenstein. The European approval of Prolia marks the first approval of the product worldwide.
"The European approval of Prolia is a significant medical advance for patients with bone loss conditions," said Will Dere, senior vice president and international chief medical officer at Amgen. "In particular, we believe that Prolia will offer patients with postmenopausal osteoporosis at increased risk for fracture an important alternative to current treatments. Prolia reduces the risk of fracture through a convenient injection given every six months. Amgen is proud to make this new treatment available to physicians and their patients."
The marketing authorization for Prolia comprises data from six Phase 3 trials, including two pivotal Phase 3 studies with fracture endpoints in the osteoporosis and prostate cancer settings, which demonstrated that Prolia administered as a 60mg subcutaneous injection every six months reduces the incidence of fractures. All six studies showed Prolia's ability to increase bone mineral density (a measure of bone strength) at all skeletal sites measured.
"Osteoporosis is a serious, chronic disease that can significantly impact the lives of millions of affected women. Despite widely available treatments, new options are still needed to help protect against fractures," said Professor Socrates E. Papapoulos, professor of medicine, consultant physician and director of bone and mineral research at the department of endocrinology & metabolic diseases of the Leiden University Medical Center, The Netherlands. "By targeting RANK Ligand, Prolia offers an innovative new approach that helps reduce fracture risk."
"The approval of Prolia in the European Union is great news for patients as it is the first and only product approved in Europe for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures," said Professor Bertrand Tombal, chairman of the division of urology and associate professor of physiology at the Universite catholique de Louvain (UCL), Cliniques universitaires Saint-Luc, Brussels, Belgium. "Bone loss can be a serious problem for men undergoing hormone ablation therapy for prostate cancer and if left untreated it can lead to fractures."
Prolia (denosumab) has a unique mechanism of action. It is the first and only approved therapy that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).
Prolia is under regulatory review in the United States (U.S.), Switzerland, Australia and Canada.
About Denosumab Collaborations
In July 2009, Amgen and GlaxoSmithKline (GSK) announced a collaboration agreement to jointly commercialize Prolia for postmenopausal osteoporosis in Europe, Australia, New Zealand and Mexico once the product is approved in these countries. Amgen will commercialize Prolia's postmenopausal osteoporosis and oncology indications in the U.S. and Canada and for all oncology indications in Europe and in other specified markets.
In addition, GSK will register and commercialize denosumab for all indications in countries where Amgen does not currently have a commercial presence, including China, Brazil, India and South Korea but excluding Japan. The structure of the collaboration allows Amgen the option of an expanded role in commercialization in both Europe and certain emerging markets in the future.
Amgen and Daiichi-Sankyo Company, Limited have a collaboration and license agreement for the development and commercialization of denosumab in Japan.
About Amgen Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.About GlaxoSmithKline GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For company information, visit GlaxoSmithKline at www.gsk.com.