"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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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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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.