UCB and Amgen Provide Regulatory Update on Status of EVENITY® (romosozumab) in the EU

 
Brussels, Belgium and Thousand Oaks, Calif. (28 June) – UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) today announced the companies have been informed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorisation Application for EVENITY® (romosozumab) for the treatment of severe osteoporosis. The companies intend to submit a written notice for a re-examination by the CHMP.
 
“We are disappointed with the CHMP opinion and believe that the body of evidence submitted supports a positive benefit:risk profile for romosozumab and its use in helping to address the urgent need to improve post-fracture care and reduce the risk of painful, disabling fractures in postmenopausal women with severe osteoporosis at high risk of fracture,” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “Together with Amgen we will seek a re-examination of the CHMP opinion. The re-examination process gives us the opportunity to clarify our position on the submitted data with the goal of making romosozumab available to postmenopausal women at high risk of fracture in the EU.”
 
The opinion is based on results from a large development program including three pivotal Phase 3 studies comprised of over 11,000 patients: FRAME, including 7,180 postmenopausal women with osteoporosis at risk for fracture;1 ARCH, including 4,093 postmenopausal women with severe osteoporosis at high risk for fracture;2 and BRIDGE, including 245 men with osteoporosis.3 
 
“After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year,4 and these fractures can be life-changing. Yet these patients often remain undiagnosed and untreated and could benefit from a new treatment option with 12 monthly doses to reduce their risk of a fracture,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We are disappointed by the Committee’s opinion and continue to believe that romosozumab has a positive benefit:risk profile. Amgen and UCB remain committed to working with regulatory authorities worldwide to bring romosozumab to patients and physicians who need additional treatment options for osteoporosis.”
 
Romosozumab was approved by the U.S. Food and Drug Administration (FDA) in April 2019 for the treatment of osteoporosis in postmenopausal women at high risk for fracture.5 Romosozumab is also approved in Japan6, and South Korea7, for the treatment of osteoporosis for women and men at high risk for fracture and in Canada8 for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
 
References
  1. Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med 2016;375:1532-1543.
  2. Saag KG, Petersen, J, Brandiet ML, et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med 2017;377:1417–27.
  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 January 14, 2019.
  4. Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following fracture. JAMA. 2001;285(3):320-323. 
  5. EVENITY™ (romosozumab-aqqg) U.S. Prescribing Information https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/evenity/evenity_pi_hcp_english.ashx 
  6. Pharmaceuticals and Medical Devices Agency Prescription Drug Database http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/112922_3999449G1025_1_02
  7. Ministry of Food and Drug Safety, Import Drug License. 20190531.
  8. Health Canada. Notice of Compliance, June 2017.
About EVENITY® (romosozumab)
Romosozumab is a bone-forming monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin, which simultaneously results in increased bone formation and to a lesser extent decreased bone resorption. The romosozumab development program includes 19 clinical studies that enrolled approximately 14,000 patients. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program that included two large fracture trials comparing romosozumab to either placebo or active comparator in over 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.
 
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 7 500 people in approximately 40 countries, the company generated revenue of € 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.
 
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, including its devices, 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’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. 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, including in Puerto Rico, 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. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen’s systems and Amgen’s data. 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. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.
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. 
 
CONTACT: 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  
T +32.2.559.94.14, antje.witte@ucb.com
 
Isabelle Ghellynck, Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com  
 
CONTACT: Amgen, Thousand Oaks
Kelley Davenport, 202-585-9637 (media)
Kristen Davis, 805-447-3008 (media) 
Arvind Sood, 805-447-1060 (investors)
 

 

 

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