Unleashing Synvisc's potential
Early in 2005, Genzyme brought Synvisc in-house with the acquisition of the sales and marketing rights in the United States and five major European countries. We are making substantial investments in this brand for the long term and are seeing results that we believe indicate Synvisc's full potential. With an expert sales force, Synvisc has already made a significant contribution to Genzyme's strength, and we expect this effect to grow in the coming years.
Synvisc continues to be the leading viscosupplementation product for treating the pain of osteoarthritis (OA) of the knee among U.S. and Canadian patients, and it is also a top contender in this category in Europe. Synvisc is marketed in more than 60 countries and has been used to treat more than 3 million people. Because market penetration is still in the early stages, there is much room for future growth. In 2005, two meta-analyses affirmed the clinical benefit of Synvisc and its class of viscosupplements. The studies were conducted using research methodologies that provide physicians and managed-care plans with tools to evaluate new treatments using an evidence-based approach. In addition to its efficacy in relieving pain, Synvisc, as a non-systemic treatment, has the advantage of avoiding the side effects associated with some non-steroidal antiinflammatory drugs including the COX-2 inhibitors.
To bring such key data to physicians and patients, Genzyme has launched sales and marketing programs directed at both clinicians and consumers, including branded direct-to-consumer television advertising. We are also significantly increasing our sales force. We are investing in research and clinical trials to expand the use of Synvisc to additional joints and to create next-generation approaches. In Europe and Canada, patients already have the benefit of Synvisc for the treatment of hip pain, and we plan to file for approval of this indication in the United States in late 2006. We also anticipate launching Synvisc for the ankle and shoulder in Europe in the first half of 2007.
Currently, Synvisc is the only viscosupplement on the U.S. market that can offer up to six months of pain relief from OA of the knee with a treatment regimen of only three injections. We are completing clinical studies of next-generation approaches that would provide the same duration of relief with two injections or fewer.
Progress on next-generation Carticel
In 2006, we plan to initiate a clinical trial of a second-generation Carticel for the U.S. market using the Matrix-assisted Autologous Chondrocyte Implantation (MACI) product that we gained with the acquisition of Verigen AG in early 2005. Carticel is a novel cell therapy used to repair injuries to articular knee cartilage that have responded inadequately to other treatment, and it has been used in more than 10,000 knees over the course of a decade. MACI is approved and sold in Europe and Australia, with manufacturing facilities in both regions.