UCB and Amgen Initiate Sclerostin Antibody Phase 3 Program in Patients With Postmenopausal Osteoporosis
First Patient Randomized Marks Start of Phase 3 Program to Evaluate Safety and Efficacy of CDP7851/AMG 785 in Women With Postmenopausal Osteoporosis
BRUSSELS and THOUSAND OAKS, Calif., April 4, 2012 /PRNewswire/ -- UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) announced today the start of their sclerostin antibody (CDP7851/AMG 785) Phase 3 clinical trial program for the treatment of postmenopausal osteoporosis.
"We look forward to working with UCB on the CDP7851/AMG 785 Phase 3 program," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Despite available osteoporosis therapies, there remains a significant need for additional treatment options that form new bone in women diagnosed with postmenopausal osteoporosis."
"Our sclerostin antibody project with Amgen is one of the most exciting pipeline programs in UCB's portfolio. Data collected so far indicate the potential for a change of treatment paradigms in postmenopausal osteoporosis," said Prof. Dr. med. Iris Loew-Friedrich, Chief Medical Officer of UCB and Executive Vice-President Global Projects and Development. "We are delighted about the start of the Phase 3 program. The progress made to date encourages and motivates us as we work toward providing a new treatment option for women living with postmenopausal osteoporosis."
The Phase 3 program includes a multicenter, international, randomized, double-blind, placebo-controlled, parallel-group, two-year study in more than 5,000 postmenopausal women with osteoporosis. The primary endpoint will evaluate the incidence of new vertebral fractures at 12 months. Initial results from the Phase 3 program are expected by the end of 2015.
CDP7851/AMG 785 is a humanized monoclonal antibody that binds to and inhibits sclerostin, a protein secreted by bone cells that inhibits bone formation. By binding to and blocking sclerostin, CDP7851/AMG 785 is designed to increase the amount of bone in the skeleton. With more than 75 million people worldwide suffering from osteoporosis, there is a serious patient need for therapeutics that help build bone. Amgen and UCB are collaborating on the development of CDP7851/AMG 785 for the treatment of bone-related conditions, including postmenopausal osteoporosis and fracture healing.
About Postmenopausal Osteoporosis
Osteoporosis is the most common disorder of bone metabolism. Osteoporosis, or porous bone, is a chronic, progressive and systemic disease marked by low bone mass, deterioration of bone tissue and low bone strength, leading to bone fragility and an increased risk of fractures. The rate of bone loss is accelerated in women during and after the menopause as a result of estrogen deficiency associated with the loss of ovarian function at menopause. The risk of fracture increases exponentially with age. The prevalence of osteoporosis is estimated to be 64.6 million people in the seven major markets; women are four times more likely than men to develop osteoporosis.
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 8,000 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2011. UCB is listed on Euronext Brussels (symbol: UCB).
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Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com. Follow us on www.twitter.com/amgen.
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This statement contains forward-looking statements that are based on management's current expectations and beliefs 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, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10- Q and Form 8-K. Please refer to Amgen'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 April 4, 2012 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 we project. 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 us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop 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 we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
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Contact: UCB, Brussels
Antje Witte, Investor Relations UCB
T +32.2.559.9414, firstname.lastname@example.org
Laurent Schots, Media Relations, UCB
T: +32 2 559 9264, email@example.com
Contact: Amgen, Thousand Oaks
Christine Regan: 805-447-5476 (Media)
Arvind Sood: 805-447-1060 (Investors)
Posted: April 2012
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