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TOKYO (Dec.20, 2016) – Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; General Manager and Representative Director: Mark Tennyson, “Amgen Astellas”) and Astellas Pharma Inc. (Headquarters, Tokyo; President and CEO: Yoshihiko Hatanaka, “Astellas”) announced that Amgen Astellas submitted an application seeking marketing approval of romosozumab (AMG785) for the treatment of osteoporosis for those at high risk of fracture for review to the Ministry of Health, Labour and Welfare in Japan. Amgen Astellas and Astellas are co-developing romosozumab in Japan.
Osteoporosis is a major public health issue in Japan. It is estimated that nearly 9.8 million women and three million men aged 40 or older have osteoporosis.1 Fractures associated with the condition may lead to impairment in mobility and interfere with activities of daily living.1
Romosozumab is an investigational monoclonal antibody that works by binding and inhibiting the activity of sclerostin, a glycoprotein secreted by osteocytes in bone, thereby increasing bone formation and decreasing bone resorption.
The Japanese New Drug Application for marketing approval for romosozumab contains data from two pivotal Phase 3 studies: the placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME) including 7,180 women with postmenopausal osteoporosis, and the placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn (BRIDGE) with osteoporosis including 245 men with osteoporosis.
In the U.S. and Canada, Amgen has submitted regulatory filings for romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Romosozumab 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. Romosozumab 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 romosozumab to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab.
About the FRAME study
FRAME is a multicenter, international, randomized, double-blind, placebo-controlled, parallel-group study in postmenopausal women with osteoporosis, defined as low bone mineral density at the total hip or femoral neck. The study evaluated the effectiveness of romosozumab treatment, compared with placebo, in reducing the risk of new vertebral fractures through 12 months. The study also further evaluated if romosozumab treatment for 12 months followed by denosumab treatment for 12 months, compared with placebo followed by denosumab treatment, was effective in reducing the risk of new vertebral fractures through 24 months. In addition, clinical fracture (a composite endpoint which encompasses all symptomatic fractures, both non-vertebral and painful vertebral fractures) risk reduction, non-vertebral fracture (fractures outside of the spine, excluding sites that are not considered osteoporotic, fractures due to high trauma or pathologic fractures) risk reduction and other endpoints were assessed at 12 and 24 months.
7,180 patients were randomized 1:1 to receive either 210 mg romosozumab subcutaneous (SC) monthly (QM) or placebo SC QM for the 12-month double-blind study period. After the placebo-controlled study period, patients entered the open-label phase where all patients received 60 mg denosumab SC every six months (Q6M) for 12 months, while remaining blinded to initial treatment. An additional 12 month extension period of open-label 60 mg denosumab SC Q6M is currently ongoing.
About the BRIDGE study
BRIDGE is a multi-center, international, randomized, double-blind, placebo-controlled study in men aged 55-90 years with a lumbar spine, total hip or femoral neck BMD T score ≤ -2.5 or ≤ -1.5 and a history of fragility non-vertebral fracture (excluding hip fracture) or vertebral fracture. The study evaluated the effectiveness of romosozumab treatment for 12 months, compared with placebo, in increasing BMD at the lumbar spine, as well as the effect on BMD at the femoral neck and total hip at 12 months and at six months, and the percent change from baseline in the serum bone turnover markers P1NP and CTX.
245 men with osteoporosis (163 romosozumab, 82 placebo) were randomized 2:1 to receive either 210 mg romosozumab or placebo subcutaneously once monthly for 12 months.
About Amgen Astellas BioPharma K.K.
Amgen Astellas BioPharma K.K. (AABP) is a Japanese company that began operations on October 1, 2013, to provide breakthrough-science-based medicines to help address unmet medical needs of patients in Japan. The company is a joint venture between Amgen, one of the world’s leading independent biotechnology companies, and Astellas Pharma Inc., a leading Tokyo-based R&D oriented global pharmaceutical company.
AABP has grown into an organization with over 300 employees and comprehensive functions to be fully operational as a marketing authorization holder in Japan. AABP’s sales organization, with 19 regional sales offices located throughout Japan, will co-promote its products with Astellas. The joint venture will become a wholly-owned Amgen affiliate as soon as 2020.
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at www.astellas.com/en.
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Amgen Astellas BioPharma K.K. Corporate Affairs, +81-3-5293-9694
Astellas Pharma Inc. Corporate Communications, +81-3-3244-3201