Genzyme Arthritis Treatment Misses Goal in Pivotal Trial; Company Will Pursue Alternative Strategy

7/5/07Follow @bbuderi

Genzyme announced today that results from a key study of hylastan, a treatment for osteoarthritis of the knee, failed to meet the company’s efficacy target. Happily for the company, it has a more viable alternative already in the works.

The hylastan study involved nearly 400 patients being treated at 27 sites in Europe and North America. While the company put some positive spin on the results, noting that hylastan users had a meaningful reduction in knee pain compared to baseline figures, the main point of the study was to demonstrate that hylastan could provide better pain relief than treatment with steroids. In this regard, the press release noted, “the trial did not meet its primary endpoint…”

The main takeaway is that the company is effectively abandoning pursuit of hylastan to focus on another product, Synvisc-One, which is a version of an already-approved product (Synvisc). Like hylastan, Synvisc-One is an attempt to improve osteoarthritis treatment, in part by providing a combined-dose regimen in a single injection, in this case three doses of regular Synvisc. Morever, Synvisc-One has had far more success than hylastan in meeting its efficacy targets. Last month, Genzyme submitted an application to the FDA seeking approval for Synvisc-One, notes senior director of corporate communications Bo Piela. “This month we intend to file for the European approval. We expect action this year on both of those applications,” he says.

Bob is Xconomy's founder and editor in chief. You can e-mail him at bbuderi@xconomy.com, call him at 617.500.5926. Follow @bbuderi

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