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UCB and Amgen Announce FDA Advisory Committee Meeting to review EVENITY™ (Romosozumab) for the Treatment of Osteoporosis in Postmenopausal Women at High Risk for Fracture

BRUSSELS, Belgium, and THOUSAND OAKS, Calif.  (Nov. 30, 2018) – Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) will review data supporting the Biologics License Application (BLA) for EVENITYTM (romosozumab) for the treatment of osteoporosis in postmenopausal women at high risk for fracture at a meeting on Jan. 16, 2019. 

“We are currently seeing a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated 77 percent of women aged 67 or older remaining undiagnosed and untreated in the first 6 months after a fracture.1 This is a stark reminder of the need to improve post-fracture care and reduce the risk of future fractures,” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “We believe romosozumab has the potential to help postmenopausal women with osteoporosis who are at high risk for fracture, and we look forward to the interactions with the members of the Committee."

The romosozumab development program includes three pivotal Phase 3 studies that included more than 11,000 patients: FRAME,2 including 7,180 postmenopausal women with osteoporosis; and ARCH,3 including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and BRIDGE,4 including 245 men with osteoporosis. The BRUDAC committee will focus its discussion on the FRAME and ARCH studies in its review of the clinical benefit:risk profile of romosozumab, including the cardiovascular safety findings seen in the ARCH study, for the potential to reduce the risk of fractures and increase bone mineral density (BMD) in postmenopausal women with osteoporosis. 

“After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year, and these fractures can be life-changing. Yet these patients often remain undiagnosed and untreated and could benefit from a potential new bone forming therapy that has been shown to reduce their risk of fracture within the first year,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We look forward to discussing the efficacy and safety data from our romosozumab clinical program with the members of the Committee.”

In July 2018, Amgen and UCB resubmitted the BLA to the FDA for romosozumab. Marketing authorization applications for romosozumab are also ongoing in other parts of the world including Europe and Japan.

References

  1. Cosman F, de Beur SJ, LeBoff MS, et al.  Clinician’s Guide to Prevention and Treatment of Osteoporosis. Osteoporosis Int. 2014; 25(10): 2359–2381.
  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. Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis. Available at: https://clinicaltrials.gov/ct2/show/NCT01631214?term=NCT01631214&rank=1. Accessed November 2018.
  4. 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, 2018

About EVENITY™ (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 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 11,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab.

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.

UCB Forward-Looking Statements
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.
There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.
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.

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. 

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. 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 metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on  Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products after they are on the market.
Amgen's results may be affected by its 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 its products and global economic conditions. In addition, sales of Amgen's 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 its products after they are on the market. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's 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 it and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key manufacturing facilities and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's 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 its business and results of operations. Amgen's efforts to acquire other companies or products and to integrate the operations of companies Amgen has acquired may not be successful. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Amgen is increasingly dependent on information technology systems, infrastructure and data security. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock.
The scientific information discussed in this news release related to Amgen's 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, Brussels  
France Nivelle, Global Communications, UCB  
T +32.2.559.9178, france.nivelle@ucb.com  
Scott Fleming, Global Communications, Bone, UCB
T +447702 777 378, 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) 
Kristen Neese, 805-313-8267 (media) 
Arvind Sood, 805-447-1060 (investors)
 


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