EVENITY® (romosozumab) Receives Approval In Japan for the Treatment of Osteoporosis In Patients at High Risk of Fracture

• EVENITY® (romosozumab) Approved To Reduce The Risk Of Fractures And Increase Bone Mineral Density In Men And Post-Menopausal Women With Osteoporosis At High Risk Of Fracture
• Romosozumab in Japan is Being Co-Developed Through a Strategic Alliance With Amgen Astellas BioPharma (AABP)

Brussels, Belgium and Thousand Oaks, Calif (January 8, 2019) – UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) today announced that the Japanese Ministry of Health, Labour and Welfare has granted a marketing authorization for EVENITY^® (romosozumab) for the treatment of osteoporosis in patients at high risk of fracture¹. UCB and Amgen 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.

“With one of the longest life expectancy rates in the world Japan is a country of longevity, but this means that the rate of osteoporosis will increase, leaving many people at high risk for fracture due to the condition,” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “We are proud that romosozumab is now approved as a new treatment to help address this important public health issue and help people with their osteoporosis.”

Romosozumab is a bone-forming agent that both increases bone formation and reduces bone resorption to increase bone mineral density (BMD) and reduce the risk of fracture. The approval is based on results from two pivotal Phase 3 studies: FRAME², which included 7,180 postmenopausal women with osteoporosis and BRIDGE³, which included 245 men with osteoporosis. The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) undertook a thorough review of the safety profile of romosozumab, including the cardiovascular safety findings in the ARCH trial.

“In Japan osteoporotic fracture is one of the leading causes for patients losing independence and needing nursing care. As the aged population of Japan increases, preventing such fractures should be given high priority,” said Steve Sugino, Amgen vice president and president and representative director of Amgen Astellas. “Japanese patients will be the first in the world to have a new therapeutic option for osteoporosis that reduces the risk of fracture by not only increasing bone formation but also decreasing bone resorption.¹” 

“Patients with a prior fracture face the risk of having another fracture and particularly stand to benefit from the option of a new bone-forming agent,” said Toshio Matsumoto, M.D., Ph.D., Emeritus Professor of Tokushima University and the advisor of the university’s Fujii Memorial Institute of Medical Sciences. “Physicians have been waiting for a new therapeutic option. I have great hope that the approval of romosozumab will help reduce the fracture risk for patients in Japan.”

Japan has one of the longest life expectancy rates in the world, and it is believed that by 2050 over 37% of the population will be aged 60 or older.⁴ Age is one of the most common risk factors that can cause a person to develop osteoporosis, as bone mass is lost over time.^5,6 Today, the prevalence of osteoporosis in the country is around 12 million and the hip fracture incidence rate in the population over 75 is increasing dramatically in both men and women.⁷

“The approval of romsozumab in Japan is a significant milestone that reinforces our commitment to bringing effective treatments to the millions of patients who suffer from osteoporosis,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “A patient with a prior osteoporotic fracture is twice as likely to suffer another fracture, if left undiagnosed and without appropriate treatment.⁸ With this approval, physicians in Japan now have a new medicine to help patients reduce their risk of fracture.” 

This is the first approval for romosozumab in the world, and the third approval of a new medicine through AABP. 

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are currently reviewing marketing applications for romosozumab and interactions with the agencies are ongoing.

References

1. Pharmaceuticals and Medical Devices Agency Prescription Drug Database http://www.info.pmda.go.jp/go/pack/39994C7G1022_1_02/
2. Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME). Available at: https://clinicaltrials.gov/ct2/show/NCT01575834?term=NCT01575834&rank=1. Accessed November 2018.
3. A Double-blind Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis (BRIDGE). Available at: https://clinicaltrials.gov/ct2/show/NCT02186171?term=NCT02186171&rank=1. Accessed November 2018, 2016.
4. Population projections for Japan, 2001-2050, The National Institute of Population and Social Security Research, 2002.
5. Kanis JA, Johnell O, Odén A, Dawson A, De LAet C, Jonsson B. Ten year probabilities of osteoporotic fractures according to BMD and diagnosis thresholds. Osteoporosis Int 2001;12:989-95
6. International Osteoporosis Foundation. Fixed Risk Factors. Available at http://www.iofbonehealth.org/fixed-risk-factors. Accessed December 2018
7. 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 2018
8. International Osteoporosis Foundation. Patient Brochure. http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-pa-tient_brochure.pdf. Accessed December 2018.  

About EVENITY (romosozumab)
Romosozumab is a bone-forming monoclonal antibody approved in Japan. It is designed to work by inhibiting the activity of sclerostin, which enables romosozumab to increase bone formation and reduce bone resorption. Romosozumab has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program included 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.

Important Japan Product Information

Product Name:
EVENITY^® subcutaneous injection 105mg syringe

Generic Name:
Romosozumab (Genetical Recombination) Injection

Indication: 

Osteoporosis at high risk of fracture

Dosage and Administration:

The usual adult dosage is 210 mg as romosozumab (genetical recombination) by subcutaneous injection once a month for 12 months.

For more information, see the Japan Package Inserts at http://www.info.pmda.go.jp/go/pack/39994C7G1022_1_02/ 

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 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 in immunology and neurology. With more than 7,500 people in approximately 40 countries, the company generated revenue of € 4.5 billion in 2017. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

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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 biologics manufacturing 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 the world’s largest independent biotechnology company, 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. 

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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.

For further information

UCB, Brussels  
France Nivelle, Global Communications, UCB  
T +32.2.559.9178, france.nivelle@ucb.com  

Laurent Schots, Media Relations, UCB  
T+32.2.559.92.64, laurent.schots@ucb.com

Antje Witte, Investor Relations, UCB  
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Isabelle Ghellynck, Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com