Message #102 From:
Stock News Bot Date: December 24, 2008 09:32:01 AM
AMGN Stock: 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., Dec. 19
/PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN stock), today announced
submission of a Biologics License Application (BLA) with the U.S. Food
and Drug Administration (FDA) for denosumab, an investigational RANK
Ligand inhibitor. The indications for which Amgen is seeking FDA
approval are treatment and prevention of postmenopausal osteoporosis
(PMO) in women, and treatment and prevention of bone loss in patients
undergoing hormone ablation for either prostate or breast cancer. The
BLA submission contains data from six Phase 3 trials involving more
than 11,000 patients.
'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 Roger M. Perlmutter,
M.D., Ph.D., executive vice president of Research and Development at
Amgen. 'Today's submission marks a significant step toward realizing
our goal of making this important therapeutic available to patients at
risk for fractures, for whom there is a significant need for new
therapies.'
Amgen also intends to submit a marketing application shortly in the European Union, Switzerland, Canada and Australia for use of denosumab in these indications.
Postmenopausal osteoporosis affects more than 200 million people worldwide(1), and can have devastating consequences. In the United States
(U.S.), one in two women over the age of 50 will fracture in her
lifetime(2), and one third of those who fracture will break another
bone within one year.(3) Osteoporotic fractures cost the U.S.
healthcare system more than $20 billion annually(2),
equivalent to the cost associated with cardiovascular disease and
asthma.(2,4,5) It has been reported that osteoporosis results in more
hospital bed-days than stroke, myocardial infarction or breast
cancer.(6)
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.
About Denosumab
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.
About Amgen
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, 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.
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(6) Lippuner K, et al. 'Incidence and direct medical costs of hospitalisations due to osteoporotic fractures in Switzerland.' Osteoporosis International. 1997;7:414-25.
(7) American Cancer Society(R). Available at: http://www.cancer.org. Accessed October 20, 2008.
