Healthcare Industry News: UCB
News Release - March 21, 2016
Amgen And UCB Announce Positive Top-Line Results From Phase 3 Study Evaluating Romosozumab In Men With OsteoporosisBRIDGE Study Met Primary and All Secondary Endpoints
Results Add to Growing Body of Positive Late-Stage Data Evaluating Efficacy and Safety of Romosozumab in Patients With Osteoporosis
THOUSAND OAKS, Calif., and BRUSSELS, March 20, 2016 -- (Healthcare Sales & Marketing Network) -- Amgen (AMGN) and UCB (Euronext Brussels: UCB) today announced positive top-line results for romosozumab from the pivotal Phase 3 placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis (BRIDGE). These data showed the BRIDGE study met the primary endpoint, demonstrating a statistically significant increase in bone mineral density (BMD) at the lumbar spine (as assessed by dual energy x-ray absorptiometry) in men with osteoporosis treated with romosozumab compared with placebo at 12 months.
"While the focus of managing osteoporosis is often on women, osteoporosis in men is also a serious health issue that poses a significant health risk to millions of men worldwide,"1 said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are excited that these data showed romosozumab stimulates bone formation, leading to increases in bone mass, in this often overlooked and undertreated patient population."2
All secondary endpoints comparing romosozumab with placebo were also met. Patients receiving romosozumab experienced a statistically significant increase in BMD at the femoral neck and total hip at 12 months and a statistically significant increase in BMD at the lumbar spine, femoral neck, and total hip at six months, compared with those receiving placebo.
"Although there has been considerable progress in the treatment and management of osteoporosis, a large unmet medical need remains. One in three women and one in five men over the age of 50 will experience an osteoporosis-related fracture in their lives,"3,4 said Professor Dr. Iris Loew-Friedrich, chief medical officer and executive vice president, UCB. "These positive results from BRIDGE add to our growing body of Phase 3 data demonstrating romosozumab's potential to build bone strength and to decrease fracture risk and thus help fill an unmet need for patients with osteoporosis."
In the BRIDGE study, a total of 245 men were randomized 2:1 to receive either 210 mg romosozumab subcutaneous (SC) every month (QM) or matched placebo SC QM for the duration of the 12-month treatment period.
The overall patient incidence of adverse events and serious adverse events (SAEs) was generally balanced between arms. The most frequently reported adverse events (greater than five percent in the romosozumab arm) were nasopharyngitis, back pain, hypertension, headache and constipation. Injection site reactions were reported in 5.5 percent of patients in the romosozumab treatment group and 3.7 percent in the placebo group during the 12-month period. Most injection site reactions were reported as mild in severity. The patient incidence of positively adjudicated cardiovascular (CV) SAEs was 4.9 percent (8/163) in the romosozumab group and 2.5 percent (2/81) in the placebo group. The patient incidence of positively adjudicated cardiovascular death was 0.6 percent (1/163) in the romosozumab group and 1.2 percent (1/81) in the placebo group. Amgen and UCB recently reported the results of the FRAME study in 7,180 postmenopausal women with osteoporosis in which the overall patient incidences of adjudicated CV SAEs were balanced.
Further analysis of the Phase 3 BRIDGE study data is ongoing and will be submitted to a future medical conference and for publication. UCB and Amgen plan to discuss these results with global regulators.
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, and has a dual effect on bone, both 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 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 BRIDGE study
BRIDGE is a multi-center, international, randomized, double-blind, placebo-controlled study in men with osteoporosis, defined as low bone mineral density (BMD) at the spine, total hip or femoral neck. The study evaluated the effectiveness of romosozumab treatment for 12 months, compared with placebo, in increasing BMD at the lumbar spine, as well as the effect on BMD at the femoral neck and total hip at 12 months and on BMD at the lumbar spine, femoral neck, and total hip at six months.
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 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.
Forward-Looking Statements – Amgen
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen 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. 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, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of March 20, 2016, and expressly disclaims any duty to update information contained in this news release.
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. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. In addition, 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 expect similar variability in the future. 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 relationships. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen's 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 Amgen and the U.S. government, Amgen could become subject to significant sanctions. Amgen performs a substantial amount of its 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 Amgen products and its product candidate development.
In addition, sales of Amgen products are affected by the 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. Government and others' regulations and reimbursement policies as well as political and public scrutiny may affect the development, usage and pricing of Amgen's products. 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. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. Amgen expects to face increasing competition from biosimilars. In addition, while Amgen routinely obtains patents for products and technology, the protection of its products offered by patents and patent applications may be challenged, invalidated or circumvented by competitors and there can be no guarantee of Amgen's ability to obtain or maintain patent protection for its products or product candidates or to prevail in intellectual property litigation. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be volatile and may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, 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 it has 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's business performance could affect or limit the ability of its Board of Directors to declare a dividend or its ability to pay a dividend or repurchase 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.
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 7 700 people in approximately 40 countries, the company generated revenue of € 3.9 billion in 2015. UCB is listed on Euronext Brussels (UCB.BR). Follow us on Twitter: @UCB_news
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.
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.
1 International Osteoporosis Foundation. Report: Osteoporosis in Men: Why Change Needs to Happen. Available at: http://share.iofbonehealth.org/WOD/2014/thematic-report/WOD14-Report.pdf. Accessed February, 2016.
2 Kaufman JM, Reginster, JY, Boonen S, et al. Treatment of osteoporosis in men. Bone. 2013 Mar; 53(1): 134–144.
3 International Osteoporosis Foundation. The Global Burden of Osteoporosis. What you need to know About Osteoporosis. Available at: http://www.iofbonehealth.org/data-publications/fact-sheets/what-you-need-know-about-osteoporosis. Accessed February 2016.
4 International Osteoporosis Foundation. Osteoporosis in the European Union in 2008: Ten years of progress and ongoing challenges (October 2008). Available at: http://www.iofbonehealth.org/sites/default/files/PDFs/EU%20Reports/eu_report_2008.pdf. Accessed February 2016.
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