Home Page

Multiple formulary listings are a step forward to ensuring that postmenopausal women have access to medicines that address the unmet medical needs associated with osteoporosis

MISSISSAUGA, ON, March 5, 2024 /CNW/ - Amgen Canada announced today that EVENITY (romosozumab) has been listed for reimbursement on nine of Canada's public formularies. With this announcement most postmenopausal women in Canada will be able to access this biologic treatment. EVENITY received Health Canada approval in 2019 and is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture.¹

Patients in Ontario², British Columbia³, Saskatchewan⁴, New Brunswick⁵, Nova Scotia⁶, Newfoundland & Labrador⁷, and patients covered by Veterans Affairs Canada⁸ and NIHB⁹, now have access to reimbursement of EVENITY for the treatment of osteoporosis in postmenopausal women who have a history of osteoporotic fracture, are at high risk for future fracture (defined as a 10-year fracture risk of ?20% as defined by the FRAX tool), are treatment naive to osteoporosis medications and are not receiving concurrent osteoporosis medications, except for calcium and/or vitamin D.  

In Quebec¹⁰, EVENITY is now reimbursed for the treatment of osteoporosis in menopausal women exposed to a high risk of fracture defined by a history of fragility fracture at the hip or vertebral column or a very high risk of fracture defined by the presence of a new fragility fracture at the hip or vertebral column in the last 24 months, or by a history of more than one fragility fracture at the vertebral column.

Osteoporosis is a chronic, age-related disease which causes fractures that have costly human and socio-economic consequences.¹¹ In Canada the disease is responsible for over 80 per cent of all fractures in people over 50.¹² After the initial fractures, one in three hip fracture patients in Canada will suffer another fracture within a year.¹² According to the World Health Organization (WHO), osteoporosis is a major public health crisis, affecting millions of people worldwide.¹³

Fewer than 20 per cent of fracture patients in Canada currently undergo diagnosis or adequate treatment for the disease.¹²

"We are pleased to see so many formularies allow patients access to a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures¹⁴ ," says Dr. Daniel Martinez, Executive Medical Director at Amgen Canada. "Over two million Canadians are affected by osteoporosis,¹¹ and this approval provides a new option for physicians when treating patients who may be at risk."

"Although many provinces have provided some coverage for bone preserving therapies for years, the fact is that bone forming therapies are optimal for patients with severe osteoporosis.  Formulary availability for EVENITY, a bone forming treatment, in many provinces—followed by maintenance care on bone preserving medications—represents an important advance in care for osteoporosis patients at highest risk of disabling fragility fractures," said Dr. David Kendler, Clinical Professor in the Division of Endocrinology at the University of British Columbia, Director of the Osteoporosis Program at ProHealth in Vancouver, BC.

"Osteoporosis is a major health burden, impacting more than two million people¹² across Canada, and the accessibility of EVENITY puts us one step closer to decreasing the rates of debilitating osteoporotic fractures," said Dr. Famida Jiwa, President and CEO, Osteoporosis Canada.

EVENITY is a bone formation humanized monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin, which simultaneously results in increased bone formation and to a lesser extent decreased bone loss. The EVENITY development program includes 19 clinical studies that enrolled more than 14,000 patients globally. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program that included two large fracture trials comparing EVENITY to either placebo or active comparator in nearly 12,000 postmenopausal women with osteoporosis. 

EVENITY is contraindicated in patients who are hypersensitive to romosozumab or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

EVENITY is contraindicated in patients with hypocalcemia. Correct pre-existing hypocalcemia prior to initiating treatment with EVENITY.

The overall safety of EVENITY was studied in 19 clinical trials involving over 14,000 patients, with the Phase 3 program consisting of nearly 12,000 patients.

EVENITY has a Serious Warnings and Precautions Box in its product label which advises that EVENITY may increase the risk of myocardial infarction (heart attack), stroke and cardiovascular death. EVENITY is not recommended in patients who have had a heart attack or stroke. Consider whether the benefits outweigh the risks in patients with other cardiovascular or cerebrovascular disease or associated risk factors. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued.

More information on Adverse Reactions may be found in the EVENITY Product Monograph.

Osteoporosis is a condition that causes bones to become thin and porous, decreasing bone strength and leading to increased risk of breaking a bone. The most common sites of broken bones from osteoporosis are the wrist, spine, shoulder and hip. Osteoporosis mainly affects women who lose bone at a rate of 2-3 per cent per year as they approach menopause as their ability to form new bone cannot counterbalance the rate at which bone is being resorbed. This bone loss leads to weakened bones over time, increasing the potential for a break.

At least one in three women and one in five men will suffer a broken bone from osteoporosis during their lifetime. Broken bones from osteoporosis are more common than heart attack, stroke and breast cancer combined. One in three people who break a hip will re-break it at one year, and over one in two will suffer another bone break within five years.

According to the World Health Organization (WHO), osteoporosis is a major public health crisis, affecting millions of people worldwide¹³ while the International Osteoporosis Foundation urges governments worldwide to make osteoporosis a healthcare priority.¹⁵

As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ontario's vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new uses for existing medicines in partnership with many of Canada's leading healthcare, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. 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 Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. 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 Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops 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 Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and 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. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. While Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key manufacturing facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to acquire other companies or products and to integrate the operations of companies Amgen has acquired may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

References

1. EVENITY™ Product Monograph. Amgen Canada Inc. (June 2019).
2. Ministry of Health - files.ontario.ca. Accessed January 22, 2024. https://files.ontario.ca/moh-frequently-requested-drugs-en-2023-12-21.pdf. 
3. Health, Ministry of. "Special Authority Drug List." Province of British Columbia, January 22, 2024. https://www2.gov.bc.ca/gov/content/health/practitioner-professional-resources/pharmacare/prescribers/special-authority/sa-drug-list. 
4. Home Page - Online Formulary 2024. Accessed January 22, 2024. https://formulary.drugplan.ehealthsask.ca/SearchFormulary/BG/883932. 
5. New Brunswick Drug Plans Formulary - Government of New Brunswick. Accessed January 22, 2024. https://www2.gnb.ca/content/dam/gnb/Departments/h-s/pdf/en/NBDrugPlan/NewBrunswickDrugPlansFormulary.pdf. 
6. Appendix III – criteria for coverage of exception status drugs. Accessed January 22, 2024. https://novascotia.ca/dhw/pharmacare/documents/Criteria-for-Exception-Status-Coverage.pdf.
7. Health and Community Services. Accessed January 22, 2024. https://www.health.gov.nl.ca/health/prescription/newformulary.asp.
8. Canada, Veterans Affairs. "Prescription Drug Program (POC 10)." Prescription Drug Program POC 10 - Programs of Choice (POC) - Health Care Benefits (Treatment Benefits) - Veterans Affairs Canada, October 3, 2023. https://www.veterans.gc.ca/eng/financial-support/medical-costs/treatment-benefits/poc10. 
9. NIHB. Accessed January 22, 2024. https://nihb-ssna.express-scripts.ca/en/0205140506092019/16/160407. 
10. "List of Medications." List of medications | Régie de l'assurance maladie du Québec (RAMQ). Accessed January 22, 2024. https://www.ramq.gouv.qc.ca/en/about-us/list-medications.
11. "Policy Makers: International Osteoporosis Foundation." IOF International Osteoporosis Foundation. Accessed January 22, 2024. https://www.osteoporosis.foundation/policy-makers.
12. "Facts and Stats: Osteoporosis Canada." Osteoporosis Canada |, October 12, 2022. https://osteoporosis.ca/facts-and-stats/.
13. Genant HK;Cooper C;Poor G;Reid I;Ehrlich G;Kanis J;Nordin BE;Barrett-Connor E;Black D;Bonjour JP;Dawson-Hughes B;Delmas PD;Dequeker J;Ragi Eis S;Gennari C;Johnell O;Johnston CC;Lau EM;Liberman UA;Lindsay R;Martin TJ;Masri B;Mautalen CA;Meunier PJ;Khaltaev. "Interim Report and Recommendations of the World Health Organization Task-Force for Osteoporosis." Osteoporosis international?: a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. Accessed January 26, 2024. https://pubmed.ncbi.nlm.nih.gov/10692972/. 
14. Saag KG;Petersen J;Brandi ML;Karaplis AC;Lorentzon M;Thomas T;Maddox J;Fan M;Meisner PD;Grauer A; "Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis." The New England journal of medicine. Accessed January 26, 2024. https://pubmed.ncbi.nlm.nih.gov/28892457/. 
15. "World Osteoporosis Day: Resounding Success with Widespread Impact: International Osteoporosis Foundation." IOF International Osteoporosis Foundation, October 27, 2023. https://www.osteoporosis.foundation/news/world-osteoporosis-day-resounding-success-widespread-impact-20231027-1608#:~:text=In%20the%20article%2C%20IOF%20President,fracture%20prevention%20a%20healthcare%20priority. 

SOURCE Amgen Canada