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UCB and Amgen Initiate Sclerostin Antibody Phase 3 Program in Patients With Postmenopausal Osteoporosis
"We look forward to working with UCB on the CDP7851/AMG 785 Phase 3 program," said
"Our sclerostin antibody project with
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.
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 Forward-looking statement
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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.
Amgen Forward-Looking Statements
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In addition, sales of our 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 as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.
The scientific information discussed in this statement related to our product candidates is preliminary and investigative and is not part of the labeling approved by the U.S.