Genzyme Corp (CAMBRIDGE, Massachusetts) announced unfavorable topline results from a pivotal study investigating the safety and efficacy of hylastan, a viscosupplementation product, in treating pain in patients with osteoarthritis (OA) of the knee. The trial did not meet its primary endpoint of demonstrating that hylastan provides  pain relief that is superior to steroids.

The double-blind, active-control hylastan trial involved nearly 400 patients with OA of the knee enrolled at 27 sites in North America and Europe. Patients were randomized to receive two intraarticular injections of hylastan delivered 2 weeks apart, a single injection of hylastan, or an injection of a corticosteroid and  were evaluated for 26 weeks following treatment. Results showed a statistically significant and clinically meaningful reduction in knee pain compared to baseline for each of the three treatment arms. However, the difference in pain reduction between patients treated with hylastan and patients treated with a corticosteroid was not significant. The safety profile of the three treatment arms appeared to be comparable in the preliminary analysis of the study results. Genzyme will continue to analyze the findings from the hylastan study to determine how this product fits into their longer-range strategy.

Hylastan is being developed as part of Genzyme's program to introduce a viscosupplementation product that can be delivered through a single injection into the knee. The goal of this effort is to simplify OA pain management, reduce the overall cost of therapy, and advance a treatment option that may expand the benefits of viscosupplementation to a broader number of patients. Genzyme's development program also includes Synvisc-Oneâ„¢, an investigational combined-dose regimen of SynviscR (hylan G-F 20) provided in a single injection, which the company is currently seeking to market in the US and Europe. Genzyme has submitted an application to the US FDA for Synvisc-One and in late July will apply for a CE Mark to introduce Synvisc-One in Europe. Regulatory action on both marketing applications is expected this year.

Genzyme Biosurgery, the business unit of Genzyme that manufactures and markets Synvisc, had first-quarter 2007 sales of Synvisc totaling $53.6 million, compared with sales of $53.3 million in the first quarter of 2006. As of January 2007, the Centers for Medicare and Medicaid Services (CMS) has grouped all viscosupplementation products into a single reimbursement code. The effect of the CMS decision was to reduce the reimbursement rate for Synvisc below its then market price, thereby possibly discouraging doctors and patients from using Synvisc. Genzyme anticipates that Synvisc-One will reenergize sales and expand the market.

—A. Techman

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