› SYNVISC®, SYNVISC-ONE™ / hylan G-F 20
› SEPRAFILM® / adhesion barrier for surgery
› CARTICEL® / autologous cultured chondrocytes
› MACI® / matrix-induced autologous chondrocyte implantation
› EPICEL® / cultured epidermal autografts
Our Orthopaedics and Biosurgical Specialties businesses demonstrate Genzyme's emphasis on important, marketleading, truly novel treatments and technology.
Synvisc, Genzyme's local-injection therapy to lubricate the knee joint for the relief of osteoarthritis (OA) pain, continues to lead the market in the United States while we expand to new global markets. We're pursuing regulatory approval of Synvisc in Japan in 2008 with a launch to follow in 2009.
Synvisc-One offers a new, single-injection option for the relief of OA knee pain. This simplified treatment could substantially expand the number of patients that can receive pain relief, while reducing the overall cost of therapy. We received approval in late 2007 for Synvisc-One in Europe and plan to file for marketing approvals in Asia, Canada and Latin America; we will continue to pursue approval for this important treatment option in the United States in 2008.
Based on a different formulation from Synvisc, Genzyme's hylastan is another single-injection viscosupplementation treatment option in development. We expect to file for marketing approval in Europe in 2008; an enhanced formulation of hylastan with an active agent will enter preclinical development in 2008 as well.
Our Biosurgical Specialties business is led by Seprafilm, a product designed to help prevent painful and sometimes debilitating adhesions after surgical procedures. Seprafilm experienced 26 percent growth in 2007. Sepraspray, a new product that could be useful both in open and laprascopic surgical procedures, is currently in a number of clinical studies in the United States and Europe, with an anticipated European launch in 2009.
Carticel and MACI are unique cell-based treatments for the repair of articular cartilage injuries of the knee. In 2007, Carticel was the first product of its kind to achieve full FDA approval; MACI is currently marketed in Europe and Asia Pacific. To address new cell therapy regulations in Europe, we initiated a MACI clinical study in early 2008 aimed at gaining European approval by the end of 2012. We're evaluating U.S. market-entry strategies that leverage this study.
The FDA approved Genzyme's Epicel in late 2007, recognizing its importance as a treatment for patients with severe, life-threatening burns. Epicel is the first product of its kind to be approved in the United States.