Cambridge, UK (Sept. 17, 2011) – Amgen today announced new long-term data showing that Prolia® (denosumab) treatment for up to eight years in postmenopausal women with low bone mass or osteoporosis was associated with a continued increase in bone mineral density (BMD), an important determinant of bone strength, and a persistent reduction in markers of bone turnover. The data were presented at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in San Diego.
Results of the Phase 2 study extension study showed that for postmenopausal women with low bone mass or osteoporosis who received up to eight years of continued treatment with denosumab, BMD at the lumbar spine and total hip increased on average by 16.8 percent and 6.9 percent as compared to baseline, respectively.1 The overall adverse event profile is consistent with events previously reported.
"We don't yet have a cure for osteoporosis, and many postmenopausal women with this condition who are at high risk for fractures require long-term therapy for this serious disease,” said lead author Michael McClung, M.D., founding director, Oregon Osteoporosis Centre. “This study provides additional data that denosumab continues to increase bone mineral density progressively over a treatment period of eight years. This study supports the long-term clinical experience of denosumab for women with this chronic condition."
This Phase 2 study extension sought to determine the effects of up to eight years of continued treatment with denosumab on BMD and bone turnover markers in postmenopausal women with low bone mass or osteoporosis.
In the original phase 2 dose-ranging trial for denosumab, 412 postmenopausal women with a BMD T-score between –1.8 and –4.0 (lumbar spine) and/or –1.8 and –3.5 (total hip or femoral neck) were enrolled. Of the 262 women who completed the parent study, 200 enrolled in the extension study, all of whom received denosumab(60 mg every 6 months). Results focused on subjects who received denosumabtreatment for up to eight years, where BMD showed gains at the lumbar spine and total hip of 16.8 percent and 6.9 percent, respectively, compared with their parent study baseline.
Osteoporosis: Impact and Prevalence
Referred to as a “silent epidemic” by the International Osteoporosis Foundation (IOF), osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. The World Health Organisation has officially declared osteoporosis a public health crisis, and the IOF is urging governments worldwide to make osteoporosis a healthcare priority.
Osteoporosis-associated fractures are a significant cause of mortality and morbidity. In 2000, the number of osteoporotic fractures in Europe was estimated at 3.79 million, of which 890,000 were hip fractures.2 Since 2001, the incidence of hip fractures in European countries has risen significantly.3 In the United States (U.S.), the number of fractures due to osteoporosis is expected to rise to more than three million by 2025.4
The direct medical cost of osteoporotic fractures in Europe is expected to rise from €31.7 billion in 2000 to €76.7 billion in 2050.5 In 2005, osteoporosis-related fractures were responsible for an estimated $19 billion in cost in the U.S., and this cost is expected to rise to approximately $25 billion by 2025.6
About Denosumab
Denosumab is the first approved therapy that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).
Denosumab is approved in the European Union (EU) 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.7
Denosumab is administered as a single subcutaneous injection of 60mg once every six months.
Important EU Safety Information6
The most common adverse reactions with denosumab were urinary tract infection, upper respiratory tract infection, sciatica, cataracts, constipation, rash, pain in extremity. The most serious adverse reactions were those of skin infections, predominantly cellulitis, reported more commonly in the denosumab group compared with placebo (0.4 percent vs. 0.1 percent) in postmenopausal osteoporosis studies. In breast and prostate cancer studies, serious adverse reactions of skin infection were similar in the denosumab and placebo groups (0.6 percent vs. 0.6 percent). In the Phase 3 placebo-controlled clinical trial in patients with prostate cancer receiving ADT, an imbalance in cataract adverse events was observed with denosumab compared with placebo (4.7 percent vs. 1.2 percent placebo). No imbalance in cataract adverse events was observed in postmenopausal women with osteoporosis or in women undergoing aromatase inhibitor therapy for nonmetastatic breast cancer.
Denosumab may lead to hypocalcaemia. Hypocalcaemia must be corrected by adequate intake of calcium and vitamin D before initiating therapy. Osteonecrosis of the jaw (ONJ) has been reported rarely in clinical studies in patients receiving denosumab at a dose of 60 mg every 6 months for osteoporosis.
Denosumab Commercialisation Collaborations
In July 2009, Amgen and GlaxoSmithKline announced a collaboration agreement to jointly commercialise denosumab for postmenopausal osteoporosis in Europe, Australia, New Zealand and Mexico once the product is approved in these countries. Amgen will commercialise denosumab in postmenopausal osteoporosis and potential oncology indications in the U.S. and Canada and for all oncology indications in Europe and in other specified markets.
In addition, GlaxoSmithKline will register and commercialise denosumab for all indications in countries where Amgen does not currently have a commercial presence, including China, India and South Korea but excluding Japan. The structure of the collaboration allows Amgen the option of an expanded role in commercialisation 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 commercialisation 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 realise the new science’s promise by bringing safe, 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, bone disease, 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 vital medicines, visit http://www.amgen.co.uk/
CONTACT: Amgen, Cambridge
Freeha Rafiq - +44 (0)1895 525581
DMO-GBR-AMG-249-2011
Date of preparation: June 2011
