Genzyme Canada Inc.: Single Injection Approved in Canada for Treatment of OA of the Knee

MISSISSAUGA, ONTARIO--(Marketwire - March 16, 2009) - Following the February 2009 approval by Health Canada, Genzyme Canada today announced the availability of Synvisc-One™ (Hylan GF-20), a single injection viscosupplement approved for Osteoarthritis (OA) of the knee. Synvisc-One is the latest addition to a growing Synvisc® family of products used to treat Osteoarthritis including: a single 2mL injection for the hip, shoulder and ankle, and a 3 X 2mL dosage format for the knee. Osteoarthritis is a common, debilitating disease that affects approximately 1 in 10 Canadians.(1)

“For Canadians with osteoarthritis, the availability of Synvisc-One provides a convenient option with proven effectiveness for those suffering needlessly from knee pain” said Brian Lewis, General Manager, Genzyme Canada.

Synvisc-One has been shown to significantly improve OA knee pain for up to 6 months with a low incidence of local side effects.(2)

“Synvisc (Hylan GF-20) 3 x 2mL injection is one of the most widely studied and therefore prescribed viscosupplements on the Canadian market.” said Dr. Jean-Pierre Raynauld, Rheumatologist at the Montreal Rheumatology Institute and at Notre-Dame Hospital, CHUM in Montreal. “Synvisc-One is opening a door to a new era of viscosupplementation; providing therapy with proven efficacy combined with the convenience of a single injection.”

OA is caused by a breakdown of cartilage, the material that cushions the ends of bones. Some studies suggest that when the joints are unable to react properly to physical stress on them, the cartilage is damaged and arthritis develops.(3)

Individuals who are the most severely affected by OA are most often seniors and women over age 55. It is also one of the major conditions that leads to disability and a limit in overall activity levels.(3)

Disease progression can take a long time and is often hard to diagnose in the beginning stages due to a lack of symptoms. The joints most commonly affected by OA are weight bearing joints, such as knees and hips. The symptoms of OA can happen at any point in the disease and can include: pain in or around a joint, stiffness or problems in moving a joint and/or swelling sometimes in a joint.(3) Clinical evidence suggests that the earlier an individual with OA seeks treatment (mild to moderate), the better their outcome.(4)

Symptoms vary depending on the severity of the disease and the age of symptom onset. Risk factors to developing OA include age, excess weight, injury and complications from other conditions, heredity and lack of physical activity.(3)

Basis of Approval(2)

A double-blind, randomized, placebo-controlled multi-centre clinical study of Synvisc-One demonstrated the product’s efficacy and safety. The trial randomized 253 patients with symptomatic knee OA over 26 weeks to receive either 6mL of Synvisc-One or saline. There was a repeat phase after 26 weeks in which 62% of the Synvisc-One patients received a second injection. In the initial phase of the study, at week 18 over 70% of the Synvisc-One group had significant pain improvement over baseline vs. placebo (54%). There were no serious AEs related to treatment and 96.7% of patients were free of local adverse events after initial treatment. After 26 weeks, there was no increased incidence of AEs after the second injection of Synvisc-One. The study demonstrated a favorable risk/benefit ratio profile for Synvisc-One and was effective in providing symptomatic pain relief for up to 6 months.

About Synvisc-One

The 6mL dose of Synvisc-One (hylan G-F 20) was developed on a prospective, randomized study comparing a range of new dosing regimes against the current Synvisc dosing regime which is 3 X 2mL 3 weeks apart. The study concluded that treatment with hylan G-F 20 was well tolerated in all groups and suggested that a single 6mL injection could be an alternative to the 3 X 2mL treatment regime.(5)

Hylan G-F-20 is a high molecular weight viscosupplement comprised of both Hylan A (80% fluid and Hylan B 20% gel). It is biologically similar to hyaluronan a natural component of synovial fluid found in joints such as the knee. Viscosupplementation with Hylan G-F 20 works by restoring the rheological and physiological state of the arthritic joint tissues. This leads to decreased pain allowing more extensive movement of the joint and can protect the cartilage cells against certain physical and chemical damage.(6)

Synvisc has been on the market since the 1990’s. Today, more than 5 million knees are treated worldwide.(7)

About Genzyme

Genzyme Corporation is a biotechnology and health care products company that develops innovative products and services for major unmet medical needs. Celebrating thirteen years in this country, Genzyme Canada Inc., located in Mississauga, Ontario is the Canadian affiliate of Genzyme Corp., headquartered in Cambridge, Massachusetts.

 (1) Vancouver Costal Health http://www.vch.ca/oasis/oa_about.htm (2) Chevalier X et al. Ann Rheum Dis 2007;66(Suppl II):494. (3) Heath Canada. Seniors and Aging. It’s Your Health 2008;1. (4) Lussier A et al. Hylan in Clinical Practice. Jour of Clin Rheum 1996; 23:9. (5) Conrozier T et al. Arch Orthop Trauma Surg 2008;in press. (6) Synvisc-One Package Insert, 2009; Genzyme Canada Inc. (7) Data on File. Genzyme Corporation. Synvisc-One™ Fact Sheet 

- Synvisc-One (a viscosupplement) is a single intra-articular injection used to decrease pain and discomfort associated with osteoarthritis of the knee for up to 6 months.(1)

- Synvisc-One is not a drug, therefore does not carry any of the possible gastrointestinal and cardiovascular issues associated with some oral medications.

- Viscosupplement treatments are used to restore the physiological and rheological states of the arthritic joint tissues.

- Synvisc-One is a high-molecular weight treatment comprised of Hylans (derivative of hyaluronan) that is similar to healthy young synovial fluid found in 18-27 year olds.(1)

- Osteoarthritis (OA) is the most common form of arthritis and affects approximately 1 in 10 Canadians.(2) Up to age 55, about the same percentage of men and women have osteoarthritis. After that age, women are more vulnerable.(3)

- Symptoms can range from very mild to very severe and can limit daily activities. Clinical evidence suggests the earlier a patient seeks treatment with viscosupplementation, the better their outcome.(4)

- Synvisc-One is a line extension to the growing Synvisc® family of products including: a 3 X 2mL injection indicated for OA of the knee and a 1 X 2mL injection indicated for the hip, shoulder and ankle.

- Synvisc (3 X 2mL) has treated over 5 million knees worldwide has over 10 years of clinical experience.(5)

- Synvisc-One is administered via 6mL intra-articular injection directly into the knee joint.

- A double-blind, randomized, placebo-controlled multi-centre clinical study of Synvisc-One demonstrated the product’s efficacy and safety. The study demonstrated symptomatic pain relief with Synvisc-One for up to 6 months and was well-tolerated upon initial and repeat treatments.(6)

 (1) Synvisc-One Package Insert, 2009; Genzyme Canada Inc. (2) Vancouver Costal Health http://www.vch.ca/oasis/oa_about.htm (3) Heath Canada. Seniors and Aging. It’s Your Health 2008;1 (4) Lussier A et al. Hylan in Clinical Practice. Jour of Clin Rheum 1996; 23:9. (5) Data on File. Genzyme Corporation. (6) Chevalier X et al. Ann Rheum Dis 2007;66(Suppl II):494.