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Press Release

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EVENITY™ (romosozumab) ARCH Study Results Published In The New England Journal Of Medicine
EVENITY Followed by Alendronate Reduced the Incidence of New Vertebral, Clinical, Non-Vertebral and Hip Fractures Compared to Alendronate Alone
Additional Details on Observed Cardiovascular Safety Signal Provided

THOUSAND OAKS, Calif. and BRUSSELS, Sept. 11, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced detailed results from the Phase 3 ARCH study showing that 12 months of EVENITY™* (romosozumab) followed by alendronate was superior in reducing new vertebral, clinical, non-vertebral and hip fracture risk in postmenopausal women with osteoporosis at high risk for fracture, compared to alendronate alone. Overall adverse events and serious adverse events were generally similar between the treatment groups with the exception of the previously reported imbalance in positively adjudicated cardiovascular serious adverse events. The results were simultaneously published in the New England Journal of Medicine (NEJM) and presented today as a late-breaking abstract at an oral scientific session at the Annual Meeting of the American Society for Bone Mineral Research (ASBMR) in Denver. 

The study found that through 24 months, postmenopausal women with osteoporosis in the EVENITY treatment group experienced a statistically significant 48.0 percent relative reduction in the risk of a new vertebral (spine) fracture compared with those receiving alendronate alone (6.2 percent versus 11.9 percent, respectively [p<0.001]). At primary analysis, women in the EVENITY treatment group also experienced a statistically significant 27.0 percent relative reduction in the risk of clinical fracture, which includes non-vertebral fracture and clinical vertebral fracture (9.7 percent versus 13.0 percent, respectively [p<0.001]).  

"The ARCH study shows that romosozumab can provide superior fracture risk reduction over alendronate, a commonly used, first-line osteoporosis treatment," said study lead author Kenneth F. Saag, M.D., M.Sc., professor of medicine at the University of Alabama at Birmingham School of Medicine. "By sharing the detailed results of efficacy and safety, we aim to help clinicians understand the future benefit:risk profile of romosozumab and its potential as a treatment option for postmenopausal women living with osteoporosis."

At primary analysis, postmenopausal women in the EVENITY treatment group experienced a statistically significant 19.0 percent relative reduction in the risk of non-vertebral fractures (8.7 percent versus 10.6 percent, respectively [p=0.04]). A 38.0 percent relative reduction in the risk of hip fractures was also observed (2.0 percent versus 3.2 percent, respectively [nominalp=0.015]), when compared to those receiving alendronate alone.

Postmenopausal women who received EVENITY achieved greater gains in bone mineral density (BMD) from baseline at all measured sites and at all time points of the study versus those receiving alendronate alone. At month 12, the percentage change from baseline was greater with EVENITY versus alendronate at the lumbar spine (13.7 percent versus 5.0 percent, respectively [p<0.001]) and total hip (6.2 percent versus 2.8 percent, respectively [p<0.001]). In a subset of patients assessed every six months, significant gains were observed beginning at month six (p<0.001) for all sites.

Overall, adverse events and serious adverse events were generally similar between the treatment groups. An imbalance in adjudicated cardiovascular serious adverse events was observed during the 12-month period in 50 patients (2.5 percent) treated with EVENITY versus 38 patients (1.9 percent) treated with alendronate, with cardiac ischemic events and cerebrovascular events accounting for the imbalance.

The percentage of patients with adverse events and serious adverse events throughout the study as well as in the initial 12-month EVENITY treatment period were balanced between the groups, including incidences of osteoarthritis, hypersensitivity, cancer and hypocalcemia. Injection site reactions, mostly mild in severity, were reported in 4.4 percent of patients in the EVENITY treatment group and 2.6 percent in the alendronate group during the initial 12-month period.

During the open-label alendronate period, there were two positively adjudicated events of osteonecrosis of the jaw, one in a patient treated with EVENITY followed by alendronate and one treated with alendronate alone. There were six patients with positively adjudicated events of atypical femoral fracture during the open-label alendronate period, two patients treated with EVENITY followed by alendronate and four treated with alendronate alone.

About the ARCH Study
ARCH (Active-contRolled FraCture Study in Postmenopausal Women with Osteoporosis at High Risk of Fracture) is a Phase 3 multicenter, international, randomized, double-blind, alendronate-controlled study of EVENITY in 4,093 postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history.

Patients were randomized 1:1 to receive either 210 mg EVENITY subcutaneously every month or 70 mg alendronate orally every week for the duration of the 12-month double-blind alendronate-controlled study period. After the double-blind active-comparator study period, patients received alendronate while remaining blinded to their initial treatment assignment. The incidence of new vertebral fracture was assessed at 24 months. The incidence of clinical fracture was assessed at the primary analysis, when 330 clinical fractures occurred or the last patient was on the study for 24 months, whichever was later. In addition, other key fracture endpoints including non-vertebral fracture and hip fracture were assessed at primary analysis.

About EVENITY™* (romosozumab)
EVENITY 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, which enables EVENITY to rapidly increase bone formation and reduce bone resorption simultaneously. EVENITY 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 EVENITY to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.

About Osteoporosis
Osteoporosis is a condition that weakens bone over time, making them thinner, more brittle and more likely to break.1 Patients who experience an osteoporotic fracture are twice as likely to suffer a future fracture, yet more than 80 percent of fractures are not treated for underlying osteoporosis.2

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 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 7,500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

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This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.

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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 Oaks
Kristen Davis, 805-447-3008 (media)
Kristen Neese, 805-313-8267 (media)
Arvind Sood, 805-447-1060 (investors)

CONTACT: UCB, Brussels 
France Nivelle, Global Communications, UCB 
T +32.2.559.9178, france.nivelle@ucb.com 
Scott Fleming, Global Communications Lead, Bone, UCB
T+447702777378, scott.fleming@ucb.com
Laurent Schots, Media Relations, UCB 
T+32.2.559.92.64, laurent.schots@ucb.com
Antje Witte, Investor Relations, UCB 
T +32.2.559.94.14, antje.witte@ucb.com
Isabelle Ghellynck, Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com  

*The trade name EVENITY™ is provisionally approved for use by the U.S. Food and Drug Administration and the European Medicines Agency.

  1. International Osteoporosis Foundation. What Is Osteoporosis? 2015. Available at: http://www.iofbonehealth.org/what-is-osteoporosis. Accessed August 4, 2017. 
  2. International Osteoporosis Foundation. Stop at One. One Fracture Leads to Another. http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-patient_brochure.pdf. Accessed August 4, 2017. 

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