Matrix-induced autologous chondrocyte implantation (MACI®), currently sold in Europe and Australia, will expand Genzyme's orthopaedic offerings in these markets as well as in the US.
Genzyme already manufactures Carticel® (autologous cultured chondrocytes), a cell therapy product designed to repair symptomatic, cartilaginous defects of the femoral condyle (medial, lateral, or trochlear) caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical procedure.
In the MACI procedure, the patient's cells are seeded onto a collagen membrane, which is fitted by a surgeon into the cartilage defect and secured without suturing. MACI eliminates the need for surgeons to suture a piece of the periosteum over the implanted cells, as is required of the Carticel procedure. As a result, MACI can be performed faster and less invasively. Genzyme plans to begin US clinical trials for MACI by the first quarter of 2006.
Earlier this year, Genzyme completed the transaction to buy back from Wyeth the sales and marketing rights to Synvisc® (Hylan G-F 20) in the US and five European countries. Synvisc, the leading viscosupplementation product in the US and Canada for the treatment of pain due to osteoarthritis of the knee and one of the top products in this category in Europe, has been used to treat more than 3 million patients worldwide. Due to its treatment regimen (delivered locally), Synvisc avoids some of the side effects associated with traditional nonsteroidal anti-inflammatory drugs and cyxclo-oxygenase-2-directed agents. Additionally, Synvisc is the only viscosupplement on the US market that can provide up to 6 months of osteoarthritis knee pain relief with just three injections per treatment regimen. Genzyme, through its Genzyme Biosurgery unit, now has full responsibility for marketing, selling, and supporting the product, which has an estimated 65% share of the US viscosupplementation market.
Synvisc has received approval from the European Union and Canada for use in osteoarthritis of the hip, the second largest indication for this disease, and Genzyme is currently conducting a clinical trial in the US in support of the hip indication. Additional clinical trials for Synvisc in osteoarthritis of the shoulder and ankle are also underway in Europe.