Please Note: This information is intended for Canadian media only.
First and only RANK Ligand inhibitor offers physicians and patients a new choice in osteoporosis therapy
To view the Social Media Release, click here: http://smr.newswire.ca/en/amgen-canada/prolia-approved-by-health-canada
MISSISSAUGA, ON, Sept. 8 /CNW/ - Amgen Canada today announced that Health Canada has approved Prolia(TM) (denosumab), the first and only RANK Ligand inhibitor, for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Unlike existing therapies, Prolia is a new, targeted therapy that treats osteoporosis by blocking the RANK Ligand protein to stop the cells that breakdown bone while increasing bone mass and bone strength, reducing the chance of breaking bones (fracture) at the hip, spine and non-spine sites measured in clinical studies.
"The approval of Prolia marks an exciting advancement for the treatment of postmenopausal osteoporosis," said Dr. Aliya Khan, Professor of Clinical Medicine, Divisions Endocrinology and Geriatrics at McMaster University. "Unlike any other treatment, Prolia decreases the formation of bone removing cells, preventing bone loss and increasing bone mass, offering Canadian women a new choice for preventing fracture."
Bones should not break without significant trauma. However, as osteoporosis is a silent disease, it often goes unnoticed and left untreated, putting one in four women over the age of 50 at risk of fracture.(1) Fracture can lead to reduction or loss of mobility, decreased independence and increased risk of death.(2-3) While osteoporosis can be treated, there are a number of challenges with current treatment options, which may lead to some women stopping treatment.(4)
"One of the major roadblocks to treating women with osteoporosis is the challenge some women face when it comes to taking their treatments as prescribed by their doctors," said Dr. Famida Jiwa, acting President & CEO, Osteoporosis Canada. "Many women stop taking their treatments because of side-effects or difficulty with keeping to their medication schedule. The danger, however, is that stopping treatment puts people at risk of bone loss and fracture."
Prolia is a novel, targeted treatment for postmenopausal women with osteoporosis at high risk for fracture, which offers physicians and patients a new treatment choice. Prolia is given by a trained healthcare professional once every six months as an injection under the skin, in contrast with current oral bisphosphonate therapies that have daily, weekly or monthly dosing regimens.
"I had significant improvement on Prolia, specifically in my spine," said Iris Richman, osteoporosis patient from London, Ontario. "Prolia has simplified my life as it's a convenient injection twice a year."
"The approval of Prolia marks the introduction of a new class of medicine in more than a decade for the treatment of postmenopausal osteoporosis," said Clive Ward-Able, Executive Director, Research & Development, Amgen Canada. "Prolia is a unique, targeted treatment offering physicians and patients a new treatment option to reduce fracture risk with dosing once every six months."
Clinical Trial Results
Health Canadas approval of Prolia is based on the pivotal Phase 3 FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every six Months) study involving 7,808 postmenopausal women with osteoporosis. In this study comparing Prolia to placebo, treatment with Prolia resulted in greater bone mass, stronger bones, and significant reduced risk for fractures at the spine, hip and other sites measured at three years.(5) Specifically, Prolia demonstrated (relative to placebo):
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- 68% reduction in incidence of vertebral (spine) fractures
- 40% reduction in incidence of hip fractures
- 20% reduction in incidence of non-vertebral (non-spine) fractures
- Significant bone mineral density increases at all sites measured (8.8
per cent at the lumbar spine, 6.4 per cent at the total hip, and 5.2
per cent at the femoral neck).(6)
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Prolia is now available to patients in Canada with a prescription from a physician.
About Prolia(TM) (denosumab)
Prolia is the first and only approved therapy that specifically targets RANK Ligand, an essential mediator of osteoclast (the cells that break down bone) formation, function and survival. Prolia is approved by Health Canada for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, nonvertebral and hip fractures.
Prolia is the trade name for denosumab in postmenopausal osteoporosis for which it is administered once every six months subcutaneously as a 60 mg dose pre-filled syringe.
Important Safety Information
The most common adverse events with Prolia as observed in the clinical trial were back pain (34.7 per cent in Prolia patients vs 34.6 per cent in patients receiving placebo), arthralgia (joint pain; 20.2 per cent in Prolia patients and patients receiving placebo) and hypertension (15.8 per cent in Prolia patients vs 16.4 per cent in patients receiving placebo).(7) The most common serious adverse events observed in the clinical trial were osteoarthritis (1.6 per cent in Prolia patients vs. 2.0 per cent in patients receiving placebo), atrial fibrillation (0.9 per cent in Prolia patients and patients receiving placebo) and pneumonia (0.9 per cent in Prolia patients and patients receiving placebo).(8)
Prolia is contraindicated for patients who are hypersensitive to the drug or any component of the product and those with hypocalcemia. Adequate intake of calcium and vitamin D is important in all patients. Hypocalcemia should be corrected with calcium and vitamin D prior to initiating Prolia. Calcium levels should be monitored in patients predisposed to hypocalcemia. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of hypocalcemia (e.g., paresthesias or muscle spasms.).(9) Overall skin infections leading to hospitalization, including cellulitis and erysipelas were reported more frequently in the Prolia (0.4 per cent) group than in the placebo (seek prompt medical attention if signs or symptoms of severe infection including cellulitis and erysipelas present. The benefit-risk profile should be considered in patients taking immunosuppressant agents before treating with Prolia.(10) Epidermal and dermal events (e.g. dermatitis, eczema and rash) occurred at a significantly higher rate in the Prolia (10.8 per cent) group compared to the placebo (8.2 per cent) group. Consider discontinuing Prolia if severe symptoms develop.(11) Osteonecrosis of the jaw (ONJ) has been reported in patients treated with denosumab or bisphosphonates. A dental examination with appropriate preventative dentistry should be considered in patients with risk factors for ONJ. If ONJ occurs during treatment, guide the management plan of each patient based on individual benefit/risk evaluation.(12) Treatment with Prolia resulted in significant suppression of bone remodeling. The significance of these findings and the effect of long-term treatment with Prolia are unknown. Monitor patients for ONJ, atypical fractures and delayed fracture healing.(13)
Amgen continues to collect safety data on an ongoing basis through extensive studies and post-marketing pharmacovigilance.
About Osteoporosis
Osteoporosis is a chronic and debilitating disease characterized by low bone mass and deterioration of bone tissue.(14) Osteoporosis affects nearly two million Canadians(15) and is a global problem that is increasing in significance as the population of the world both increases and ages. It is known as the 'silent thief' because bone loss often occurs without symptoms.(16) At least 80 per cent of fractures in people over 60 years of age are related to osteoporosis,(17) and the most common sites of osteoporosis-related fractures are the hip, spine and wrist.(18) Despite the availability of existing osteoporosis treatments, the annual incidence of fractures continues to be substantial.(19),(20), (21) Eighty per cent of hip fractures are related to osteoporosis.(22) Within six months of suffering a hip fracture, almost one out of every four women wil die of complications related to the fracture.(23) Of those who survive, half will suffer from disability.(24) The lifetime risk of hip fracture is greater (one in six) than the one in nine lifetime risk of developing breast cancer.(25)
For more information about osteoporosis, visit healthandbone.ca.
About Amgen
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new sciences 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 broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve peoples lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.ca.
Forward-Looking Statements
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 U.S. 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 August 27, 2010 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.
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 applicable 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.
Video News Release will be available via satellite on Wednesday, September 8th, 2010:
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Video News Release also available via download Wednesday, September 8th, 2010:
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Audio News Release available September 8th, 2010:
http://www.newscanada.com/Radio-New-Releases (click link or copy and paste link in your browser or go to www.newscanada.com and visit the radio section under new releases)
Editors Note: Physicians and patients are available for interviews.
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References
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(1) Facts and Statistics. Osteoporosis Canada. Accessed at
http://www.osteoporosis.ca/index.php/ci_id/8867/la_id/1.htm
(2) "What is Osteoporosis?" Osteoporosis Canada. Accessed at
http://www.osteoporosis.ca/index.php/ci_id/5526/la_id/1.htm
(3) Facts and Statistics. Osteoporosis Canada. Accessed at
http://www.osteoporosis.ca/index.php/ci_id/8867/la_id/1.htm
(4) Melo M, et al. Persistence with bisphosphonate therapy in older
people. J Am Geriatr Soc 2006; 54:1015-1016
(5) Cummings SR et al. Denosumab for Prevention of Fractures in
Postmenopausal Women with Osteoporosis. N Engl J Med. 2009; 361(8):756-65.
(6) Prolia(TM) Product Monograph. Amgen Canada Inc. August 2010, page
23.
(7) Prolia(TM) Product Monograph. Amgen Canada Inc. August 2010, page
8.
(8) Prolia(TM) Product Monograph. Amgen Canada Inc. August 2010, page
8.
(9) Prolia(TM) Product Monograph. Amgen Canada Inc. August 2010, page
4.
(10) Prolia(TM) Product Monograph. Amgen Canada Inc. August 2010, page
4.
(11) Prolia(TM) Product Monograph. Amgen Canada Inc. August 2010, page
4,5.
(12) Prolia(TM) Product Monograph. Amgen Canada Inc. August 2010, page
5.
(13) Prolia(TM) Product Monograph. Amgen Canada Inc. August 2010, page
5.
(14) "What is Osteoporosis?" Osteoporosis Canada. Accessed at
http://www.osteoporosis.ca/index.php/ci_id/5526/la_id/1.htm
(15) "What is Osteoporosis?" Osteoporosis Canada. Accessed at
http://www.osteoporosis.ca/index.php/ci_id/5526/la_id/1.htm
(16) "What is Osteoporosis?" Osteoporosis Canada. Accessed at
http://www.osteoporosis.ca/index.php/ci_id/5526/la_id/1.htm
(17) Facts and Statistics. Osteoporosis Canada. Accessed at
http://www.osteoporosis.ca/index.php/ci_id/8867/la_id/1.htm
(18) Facts and Statistics. Osteoporosis Canada. Accessed at
http://www.osteoporosis.ca/index.php/ci_id/8867/la_id/1.htm
(19) Mann E et al. Hip fracture incidence in the elderly in Austria: an
epidemiological study covering the years 1994 to 2006. BMC Geriatr. 2008 Dec
23;8:35.
(20) Icks A et al. Trend of hip fracture incidence in Germany 1995-2004:
a population-based study. Osteoporos Int. 2008 Aug;19(8):1139-45. Epub 2007
Dec 18.
(21) Islam S et al. Trend in incidence of osteoporosis-related fractures
among 40- to 69-year-old women: analysis of a large insurance claims database,
2000-2005. Menopause. 2009 Jan-Feb;16(1):77-83.
(22) "What is Osteoporosis?" Osteoporosis Canada. Accessed at
http://www.osteoporosis.ca/index.php/ci_id/5526/la_id/1.htm
(23) "How does it impact ones life?" Healthandbone.ca. Accessed at:
http://www.healthandbone.ca/en/what_is_osteoporosis/how_does_it_impact_life/
(24) "What is Osteoporosis?" Osteoporosis Canada. Accessed at
http://www.osteoporosis.ca/index.php/ci_id/5526/la_id/1.htm
(25) Facts and Statistics. Osteoporosis Canada. Accessed at
http://www.osteoporosis.ca/index.php/ci_id/8867/la_id/1.htm
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