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UCB and Amgen Provide Update on Regulatory Status of EVENITY™ (romosozumab) in the U.S.

BRUSSELS, Belgium and THOUSAND OAKS, Calif. (00:01, 17 July, 2017) – UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologics License Application (BLA) for EVENITY™* (romosozumab) as a treatment for postmenopausal women with osteoporosis.
 
The original submission included data from the pivotal phase 3 placebo-controlled FRAME study of postmenopausal women with osteoporosis. With the availability of data from the phase 3 active-comparator ARCH study, the Agency has asked that the efficacy and safety data from the study be integrated into the application. The resubmission will also include the efficacy and safety data from the BRIDGE study, the phase 3 trial evaluating romosozumab in men with osteoporosis, which has also been requested. This request will be addressed in the form of a resubmission, which is an extension of the current review.
 
“The reality is that once a woman has a fragility fracture, she is five times more likely to suffer another within a year. This is a stark reminder that there is an urgent need to improve post-fracture care and reduce the risk of painful, disabling fractures in the future.” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “With all three pivotal romosozumab Phase 3 studies now included in the clinical evidence package, representing data from more than 11,000 patients, we are committed to bringing this important potential new treatment to those people living at risk of fragility fractures.”
 
“During our interactions with the FDA, we agreed that the ARCH data should be considered in the regulatory review prior to the initial marketing authorization and, as a result, we had anticipated this request. We look forward to working through the review process with the Agency,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We remain committed to helping patients with osteoporosis and will use the additional time to better understand the benefit:risk profile of romoszumab.” 
 
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, which enables romosozumab to rapidly increase bone formation and reduce bone resorption simultaneously. Romosozumab has been 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 Pivotal Romosozumab Clinical Trials
FRAME (FRActure study in postmenopausal woMen with ostEoporosis) is a randomized, double-blind, placebo-controlled study that evaluated 7,180 postmenopausal women with osteoporosis. The study evaluated the effectiveness of romosozumab treatment (210 mg), compared with placebo, in reducing the risk of new vertebral fractures through 12 months. The study also evaluated the effectiveness of treating with romosozumab for 12 months followed by denosumab for 12 months, compared with placebo followed by denosumab, in reducing the risk of new vertebral fractures through 24 months. 
 
ARCH (Active-contRolled fraCture study in postmenopausal women with osteoporosis at High risk of fracture) is a randomized, double-blind, alendronate-controlled study of romosozumab in 4,093 postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history. The study evaluated 12 months of romosozumab treatment (210 mg) followed by at least 12 months of alendronate treatment (70 mg), compared with alendronate treatment alone, to determine effectiveness in reducing the incidence of clinical fracture (non-vertebral fracture and clinical vertebral fracture) and new vertebral fracture.
 
BRIDGE (placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinGmEn with osteoporosis) is a randomized, double-blind, placebo-controlled study of 245 men aged 55-90 years with osteoporosis and a history of fragility  fracture (excluding hip fracture) or vertebral fracture. The study evaluated the effectiveness of romosozumab treatment for 12 months, compared with placebo, in increasing bone mineral density (BMD) at the lumbar spine and the effect on BMD at the femoral neck and total hip.
 
About the UCB and Amgen 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 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
 
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.
 
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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.
 
Amgen Forward-Looking Statements
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Amgen’s results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of Amgen products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Amgen’s business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of our commercial manufacturing activities at a few key facilities and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of Amgen’s marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen products are supplied by sole third-party suppliers. Certain of Amgen’s distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen’s business and results of operations. Amgen’s efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. Amgen may not be able to access the capital and credit markets on terms that are favorable to Amgen, or at all. Amgen is increasingly dependent on information technology systems, infrastructure and data security. Amgen’s stock price is volatile and may be affected by a number of events. Amgen’s business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.
 
For further information
UCB
France Nivelle, Global Communications, UCB
T +32.2.559.9178, france.nivelle@ucb.com 
Scott Fleming, Communications Lead, Bone, UCB
T+447747777378, 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
 
Amgen, Thousand Oaks 
Kristen Davis, 805-447-3008 (media)
Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)
 
*The trade name EVENITY™ is provisionally approved for use by the U.S. Food and Drug Administration and the European Medicines Agency. HQ/0717/RMZ/00037
 
 

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