Amgen And UCB Announce Submission Of Application For Investigational Osteoporosis Medication Romosozumab In Japan

PR Newswire

THOUSAND OAKS, Calif. and BRUSSELS, Dec. 19, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that an application seeking marketing approval of romosozumab for the treatment of osteoporosis for those at high risk of fracture has been submitted for review to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Amgen and UCB are co-developing romosozumab worldwide, with development in Japan being led by Amgen Astellas BioPharma (AABP) K.K., a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo.

Japan has one of the longest life expectancy rates in the world, and it is believed that the percentage of the population over 60 will be over 37 percent in 2050.¹ As such, osteoporosis among the aging population in Japan is a major public health issue. Today, the prevalence of osteoporosis in the country is around 12 million and the hip fracture incidence rate in the oldest population (over 75) is increasing dramatically in both men and women.^2,3

"Submitting romosozumab for marketing approval in Japan is an important milestone in our global development program with UCB and our strategic alliance with Astellas Pharma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to working with regulatory authorities in Japan with a goal of filling a great unmet need for patients with osteoporosis at high risk of fracture."

Romosozumab is an investigational monoclonal antibody that works by binding and inhibiting the activity of the protein sclerostin, and as a result, has a dual effect, both increasing bone formation and decreasing bone resorption.

"Our collaborative, patient-led and science-driven approach is bringing much needed treatment options to people living at risk of fracture due to osteoporosis," said Dr. Pascale Richetta, head of bone and executive vice president, UCB. "We look forward to working with our partners, Amgen and Astellas, as we pursue our goal of bringing this important new treatment to those people living at risk of fracture from osteoporosis worldwide."

The Japanese New Drug Application for marketing approval for romosozumab contains data from two pivotal Phase 3 studies: FRAME (the placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis) including 7,180 women with postmenopausal osteoporosis, and BRIDGE (the placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis) including 245 men with osteoporosis.

In the U.S. and Canada, Amgen has completed submission of regulatory filings for romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

About Romosozumab
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 multicenter, international, randomized, double-blind, placebo-controlled study in men aged 55-90 years with a lumbar spine, total hip or femoral neck bone mineral density (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 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 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 Amgen Astellas BioPharma K.K.
Amgen Astellas BioPharma K.K. (AABP) is a Japanese company that began operations on Oct. 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.

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 € 3.9 billion in 2015. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

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Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

CONTACT: Amgen, Thousand OaksKristen Davis, 805-447-3008 (media)Kristen Neese, 805-313-8267 (media)Arvind Sood, 805-447-1060 (investors)

CONTACT: Amgen Astellas BioPharma K.K.
Corporate Affairs, +81-3-5293-9694

CONTACT: Astellas Pharma Inc.
Corporate Communications, +81-3-3244-3201

CONTACT: UCB, Brussels France Nivelle, Global Communications, UCB
T +32.2.559.9178, [email protected] Laurent Schots, Media Relations, UCB
T+32.2.559.92.64, [email protected] Antje Witte, Investor Relations, UCB
T +32.2.559.94.14, [email protected] Isabelle Ghellynck, Investor Relations, UCB
T+32.2.559.9588, [email protected]

¹ Population projections for Japan, 2001-2050, The National Institute of Population and Social Security Research, 2002.
²Sone T, et al. Prevalence of osteoporosis in Japan and the international comparison. Nippon Rinsho. 2004; 62 (Suppl.2):197-200.
3 International Osteoporosis Foundation. Asian_regional_audit_Japan. Available at: https://www.iofbonehealth.org/sites/default/files/PDFs/Audit%20Asia/Asian_regional_audit_Japan.pdf. Accessed December 1, 2016.