- News & Events
- Contact Us
Amgen Submits Biologics License Application for FDA Approval of Denosumab in Women With Postmenopausal Osteoporosis and in Patients Undergoing Hormone Ablation for Either Prostate or Breast Cancer
THOUSAND OAKS, Calif.,
"Two Phase 3 pivotal studies with fracture endpoints, in the PMO and
prostate cancer settings, demonstrated denosumab's ability to reduce fracture,
and all six studies showed denosumab's ability to increase bone mineral
density at all skeletal sites measured," said
Postmenopausal osteoporosis affects more than 200 million people
worldwide(1), and can have devastating consequences. In the
In the U.S., prostate cancer is the most common cancer in men and breast cancer is the most common cancer in women.(7) It is common for prostate cancer and breast cancer patients to receive hormone ablation therapies that can lead to a decrease in bone mass and increased risk of fractures. Currently there are no approved therapies for bone loss in patients undergoing hormone ablation for either prostate or breast cancer.
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Denosumab is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. Denosumab is being studied in a range of bone loss conditions including PMO, rheumatoid arthritis, and bone loss in patients undergoing hormone ablation for prostate and breast cancer, as well as for its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer.
This news release 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
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.
In addition, sales of our products are affected by the reimbursement
policies imposed by third-party payors, 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 health care cost containment as well as
The scientific information discussed in this news release related to our
product candidates is preliminary and investigative. Such product candidates
are not approved by the
The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.
(2) "Osteoporosis Fast Facts."
(3) Foley K, et al, 2008.
(4) Burge R, et al. J Bone Miner Res. 2007; 22:465-475
(5) "Economic Cost of Cardiovascular Diseases."
(6) Lippuner K, et al. "Incidence and direct medical costs of
hospitalisations due to osteoporotic fractures in
Arvind Sood: (805) 447-1060 (investors)