CONTINUING LEADERSHIP WITH SYNVISC
The leading product of its kind in the United States, our viscosupplement Synvisc treats pain of the knee caused by osteoarthritis (OA). Synvisc is positioned to further expand its market leadership through ongoing innovation to benefit patients and the efficiency of its vertically integrated operation. Synvisc has considerable opportunity for growth in the United States, where we estimate that only 7 percent of the potential market has been tapped and where we are engaged in an ongoing patient education initiative. Growth prospects are also excellent around the world, where Synvisc now benefits patients in more than 70 countries. In late 2006, we filed for marketing approval of Synvisc in Japan, and we plan to begin direct sales in China in 2007.
In Europe, Canada, and numerous countries in Latin America and Asia, Synvisc is approved for OA pain in the hip as well as the knee. In late 2006, the European Union recognized the benefits of Synvisc use in other major joints by expanding its label to include the ankle and shoulder. In 2006, results of an independent study that demonstrated the superiority of Synvisc compared with the viscosupplement Hyalgan were presented at three major medical meetings. The findings showed that the patients who received Synvisc experienced a significantly greater magnitude of pain relief, which occurred earlier and lasted longer.
INNOVATION AND INVESTMENT
To enhance our leadership position, we have invested in Synvisc in a way that has demonstrated a clinical difference and has also responded to patient desire for greater convenience. In late 2006, Genzyme announced results from a clinical study of Synvisc using a new dosing regimen that would replace a regimen of three injections with one for the same duration of pain relief. Based on the positive trial results, we plan to file for a label change in 2007. The single-injection regimen should reduce the treatment burden to patients. We anticipate receiving approval for the label change in Europe and the United States late in the year.
We are developing hylastan, a next-generation viscosupplement with a different source of hyaluronan (HA). Hylastan is also designed as a single injection for 26 weeks of pain relief. We anticipate having data from the pivotal trial of hylastan in 2007 and plan to file for U.S. and European regulatory approval late in the year.
SEPRA PRODUCTS DEVELOPMENTS
In addition to Synvisc, Genzyme's rich biomaterials platform has yielded Seprafilm and other Sepra-family products used in surgical applications around the world to prevent adhesions from forming. We are pursuing a large opportunity for Seprafilm in the OB/GYN market and anticipate expanding our sales force in 2007. We also plan to initiate clinical trials for Sepraspray, a new product for both open and minimally invasive surgery.