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.
Author: Robert Buderi
Bob is Xconomy's founder and chairman. He is one of the country's foremost journalists covering business and technology. As a noted author and magazine editor, he is a sought-after commentator on innovation and global competitiveness. Before taking his most recent position as a research fellow in MIT's Center for International Studies, Bob served as Editor in Chief of MIT's Technology Review, then a 10-times-a-year publication with a circulation of 315,000. Bob led the magazine to numerous editorial and design awards and oversaw its expansion into three foreign editions, electronic newsletters, and highly successful conferences. As BusinessWeek's technology editor, he shared in the 1992 National Magazine Award for The Quality Imperative.
Bob is the author of four books about technology and innovation. Naval Innovation for the 21st Century (2013) is a post-Cold War account of the Office of Naval Research. Guanxi (2006) focuses on Microsoft's Beijing research lab as a metaphor for global competitiveness. Engines of Tomorrow (2000) describes the evolution of corporate research. The Invention That Changed the World (1996) covered a secret lab at MIT during WWII. Bob served on the Council on Competitiveness-sponsored National Innovation Initiative and is an advisor to the Draper Prize Nominating Committee. He has been a regular guest of CNBC's Strategy Session and has spoken about innovation at many venues, including the Business Council, Amazon, eBay, Google, IBM, and Microsoft.
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