Genzyme's future growth will be driven by fulfilling unmet patient needs. Our diversified, multiplatform approach has resulted in our unprecedented late-stage pipeline.
Tolevamer: a novel approach
Long viewed as a medical nuisance among hospitalized patients taking antibiotics, Clostridium difficile-associated diarrhea (CDAD) has emerged as a major public health problem. In 2003, approximately 2,000 hospital patients in Quebec died of CDAD, and in 2005 outbreaks struck Europe. A new strain of the bacterium is associated with increased severity and mortality, and the U.S. Centers for Disease Control and Prevention has identified cases among otherwise healthy people.
Genzyme is now conducting international phase 3 clinical trials - the largest undertaken in CDAD - of tolevamer, our new nonabsorbed, polymer-based therapy. Tolevamer is the first non-antibiotic approach to treating CDAD. Virtually all antibiotics play a role in this disease because they alter the normal, protective bacteria in the colon. Tolevamer has the potential not only to treat CDAD, but to reduce the rate of recurrence that often results in repeat hospitalizations. This therapy has fast track designation in the United States, where CDAD affects an estimated 400,000 patients each year and is responsible for up to 5,000 deaths.
Campath: potential in MS
Our leukemia drug Campath (alemtuzumab) shows great promise for treating multiple sclerosis. In 2005, analysis of the interim data from our phase 2 clinical trial of alemtuzumab in comparison with Rebif showed that patients on alemtuzumab experienced at least a 75 percent greater reduction in the risk of relapse after one year of follow-up. They also were at least 60 percent less likely to progress to clinically significant disability. At the same time, alemtuzumab was associated with significant side effects in a few patients. Together with our development partner Schering AG, we have studied this issue and created a comprehensive risk management plan. Working closely with the U.S. Food and Drug Administration (FDA) on safety, we anticipate the resumption of dosing in the three-year trial during the first half of 2006. We expect to begin a phase 3 trial during the year.
Synvisc: room to grow
Since we acquired the sales and marketing rights to Synvisc in the United States and several European countries in early 2005, we have invested in programs to expand this leading viscosupplementation product by educating both clinicians and patients about its clinical benefits. These programs are showing early success. We are also seeking to expand Synvisc in additional ways, including use in joints other than the knee and through next-generation formulations.
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