FOSAVANCE®
FOR IMMEDIATE RELEASE
BETTER ACCESS FOR A TREATMENT TO HELP OSTEOPOROSIS PATIENTS
Positive CDR recommendation and drug plan listing in Ontario for FOSAVANCE® 70/5600
Montréal, Québec – June 17, 2009 – Osteoporosis patients on public drug plans in Canada are a step closer to access to FOSAVANCE®70/5600 (alendronate sodium/cholecalciferol), an oral medicine indicated to treat osteoporosis in postmenopausal women and in men. On June 17, 2009, the Canadian Expert Drug Advisory Committee (CEDAC) through the Common Drug Review (CDR) has recommended that FOSAVANCE® 70/5600 (alendronate sodium/cholecalciferol) be listed on publicly funded drug plans. The CDR recommended that alendronate 70mg/cholecalciferol 5600 IU (vitamin D3) be reimbursed similar to generic alendronate. Furthermore, the Ontario Drug Benefit (ODB) Formulary/Comparative Drug Index has announced that based on the decisions by the Executive Officer and recommendations by the Committee to Evaluate Drugs (CED), the Ontario government will be listing FOSAVANCE® 70/5600 (alendronate sodium/cholecalciferol) effective on June 23, 2009. FOSAVANCE®70/5600 (alendronate sodium/cholecalciferol) is indicated for the treatment of osteoporosis in post-menopausal women and in men. Developed by Merck, alendronate sodium is a member of a class of non-hormonal drugs called bisphosphonates. Cholecalciferol is the natural form of vitamin D.
"This listing by the Ontario government is good news for those individuals with osteoporosis since it will help decrease their risk of fracture and supports physicians in controlling osteoporosis. The recommendation of the CDR may encourage publicly funded drug plans in the rest of Canada to include FOSAVANCE® 70/5600 on their list of reimbursed medicines," said Dr J. D. Adachi, Professor at the Department of Medicine, St. Joseph's Healthcare, McMaster University. "Osteoporosis may significantly affectlife expectancy andquality of life due to the fragility fractures. With these decisions, osteoporosis patients living in Canada will now have better access to alendronate sodium/cholecalciferol in order to maintain bone mineral density (BMD) and prevent fracture."
Too little vitamin D leads to inadequate calcium absorption and low phosphate – the minerals that make bones strong. Even by eating a diet rich in calcium or taking calcium supplement, patients cannot absorb calcium properly unless there is adequate levels of vitamin D. Lower quantities of vitamin D may lead to bone loss and osteoporosis. FOSAVANCE® 70/5600 (alendronate sodium/cholecalciferol) makes the bone stronger and less likely to fracture, thus reverses the progression of osteoporosis1.
Information about FOSAVANCE®
FOSAVANCE® 70/5600 (alendronate sodium/cholecalciferol) was approved in Canada in August 2008and is indicated for the treatment of osteoporosis in postmenopausal women and osteoporosis in men. For the treatment of osteoporosis, the alendronate sodium component increases bone mass and can prevent fractures, including those of the hip and spine (vertebral compression fractures)1. Patients suffering from osteoporosis are at an increased risk for vitamin D insufficiency. The recommended dosing regimen is one tablet of FOSAVANCE® 70/5600 IU dosed once a week. It must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only. Osteoporosis Canada Guidelines recommend 800 IU vitamin D3 intake per day in adults over 50 years. Side effects usually have been mild. Some patients may experience digestive problems such as nausea, vomiting or black and/or bloody stools. Some patients may experience bone, muscle and/or joint pain which rarely is severe. Rarely, patients have had jaw problems associated with delayed healing and infection, often following tooth extraction. Rarely, patients have experienced fracture in a specific part of the thigh bone. FOSAVANCE® 70/5600 (alendronate sodium/cholecalciferol) is also listed on the Liste des medicaments du Québec, the Quebec public drug plan, and many private drug plans across Canada.
About Merck Frosst Canada Ltd
At Merck Frosst, patients come first. Merck Frosst Canada Ltd is a research-driven pharmaceutical company discovering, developing and marketing a broad range of innovative medicines and vaccines to improve human health. Merck Frosst is one of the top 25 R&D investors in Canada, with and investment close to $110 million in 2007. More information about Merck Frosst and FOSAVANCE® is available at www.merckfrosst.com.
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Media contact:
Natacha Raphaël
Manager, Public Affairs
Merck Frosst Canada Ltd.
514-428-3280
FOSAVANCE® is a Registered Trademark of Merck & Co., Inc. Used under license
1FOSAVANCE®, Product monograph
