OREANDA-NEWS. October 13, 2015. Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today presented additional findings from an exploratory sub-study of the previously reported romosozumab Phase 2 trial.1 The findings were presented today in an oral plenary session at the American Society for Bone and Mineral Research (ASBMR) 2015 Annual Meeting in Seattle.

The small exploratory sub-study data showed that, at month 12, the investigational bone-forming agent romosozumab increased estimated bone strength (percent change from baseline) at the spine and hip more than open-label teriparatide in postmenopausal women with low bone mass. These results were measured by a validated method called finite element analysis (FEA), which utilized quantitative computed tomography (QCT) scans to simulate compression overload to estimate vertebral strength, and a sideways fall to estimate femoral strength.2

"Engineers and physicists have long used finite element analysis to better understand the structural integrity and failure of physical objects when subjected to load," said lead investigator

Tony M. Keaveny, Ph.D., professor of Mechanical Engineering and Bioengineering at the University of California, Berkeley. "By applying this analysis to bone scans of postmenopausal women with low bone mass, we were able to integrate the information we had on bone mineral density and structure to estimate bone strength in those treated with romosozumab."

The FEA showed that, at the spine, women in the romosozumab group (210 mg once monthly, n=24) increased estimated strength compared to baseline by 27.3 percent at month 12, which was greater than placebo (–3.9 percent, n=27) and teriparatide (18.5 percent, n=28).2 At the hip, the estimated strength increased from baseline by 3.6 percent with romosozumab (n=9), compared with placebo (-0.1 percent, n=18) or teriparatide (-0.7 percent, n=19).2

These data are from a small exploratory sub-study (n=79) of a Phase 2 trial (NCT00896532) that included a total of 419 patients. A subset of these women underwent spine and hip QCT imaging to measure bone mineral density (BMD) gains.3 To investigate the effects of romosozumab on bone strength an FEA was performed on these QCT scans.  

"The strength improvements observed with romosozumab in this trial – and documented using a validated method for assessing fracture risk and monitoring treatment – further support its potential as a treatment option for patients at high risk for fracture," said

Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "These important new data support our extensive global Phase 3 program of romosozumab, and we look forward to advancing this research to help provide a potential new treatment option for appropriate patients."

Adverse events in the original Phase 2 study were similar across groups, except for mild, generally non-recurring injection site reactions observed more frequently with romosozumab compared to placebo, but with no observed dose-related relationship. The most common adverse events included mild upper respiratory tract infection, pain in the back and joints, and headache. These reactions did not lead to study drug discontinuation or study withdrawal; the safety of romosozumab will be further addressed in subsequent larger studies.

"These data illustrate the potential impact of building bone through both increasing bone formation and decreasing bone resorption as romosozumab has demonstrated in skeletal regions of interest. These sub-study results reinforce our confidence in the ability of romosozumab to build bone strength as well as density and we look forward to reporting the outcomes of the first fracture study in 2016," said Professor Dr.

Iris Loew-Friedrich, chief medical officer and executive vice president at UCB.

About Finite Element Analysis

Finite element analysis (FEA) is a computer model of a material or design that is stressed and analyzed and tested for specific results. This involves breaking down an object into a large number of finite elements (e.g., small cubes), and using mathematical equations to help predict the behavior of each element. These behaviors are then calculated by a computer to predict the behavior of the object as a whole.

FEA has been applied for the past 40 years to simulate the mechanical behavior of bone, helping to predict strength at major fracture sites, like the lumbar spine and femoral hip.

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 protein sclerostin, thereby increasing bone formation and decreasing bone breakdown. Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program evaluating the safety and efficacy of romosozumab includes two large fracture trials comparing romosozumab to either placebo or active comparator in more than 10,000 postmenopausal patients with osteoporosis. Primary results from the Phase 3 study FRAME are expected in the first half of 2016. Romosozumab is being co-developed by Amgen and UCB.

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 one of the world's largest 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 8500 people in approximately 40 countries, the company generated revenue of € 3.3 billion in 2014. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

Forward-Looking Statements - Amgen

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen or us) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. 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 (SEC) reports filed by Amgen Inc., including Amgen Inc.'s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Oct. 12, 2015, and expressly disclaims any duty to update information contained in this news release.

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Forward-Looking Statements – UCB

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

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

References

1 McClung MR, Grauer A, Boonen S, et al. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014 Jan 30;370(5):412-20.

2 Keaveny TM et al. Romosozumab improves strength at the lumbar spine and hip in postmenopausal women with low bone mass compared with teriparatide. Abstract 1143, Oral Presentation, ASBMR, October 2015.

3 Genant KH et al. Effect of Romosozumab on Lumbar Spine and Hip Volumetric Bone Mineral Density (vBMD) as Assessed by Quantitative Computed Tomography (QCT). Presentation Number: 1022, ASBMR October 2013.