ZymoGenetics plans to finish phase 3 trial of recombinant human Thrombin, file BLA this year

By Jennifer Lanning Drey

Eugene, Ore., June 13 - ZymoGenetics, Inc. expects to complete its pivotal phase 3 clinical trial and file a Biologistics License Application for recombinant human Thrombin (rhThrombine) before the end of the year, according to Dr. Doug Williams, president and chief executive officer for the company.

ZymoGenetics' goal is to obtain a broad-based label that would allow recombinant human Thrombin to be used as a topical surgical hemostat, as opposed to being labeled for a specific surgical indication, Williams said Tuesday in a presentation at the Pacific Growth Equities Life Science Growth Conference.

"We think our clinical program will support this type of labeling," he said.

ZymoGenetics currently has a phase 3 randomized, double-blind placebo clinical trial underway that will study the drug in between 400 and 600 patients. Its primary endpoint is incidence of hemostasis at 10 minutes.

If approved, ZymoGenetics expects recombinant human Thrombin to compete with plasma-derived bovine Thrombine products currently on the market, Williams said during the presentation.

"What we're planning to bring to the market is the preferred alternative to a plasma-derived Thrombine preparation," he said.

Bovine Thrombine features a black box warning stating that it has occasionally been associated with abnormalities in hemostasis, Williams added.

"Improved safety, we think, is going to drive market expansion," he said.

ZymoGenetics will focus on marketing recombinant human Thrombin to surgeons who are not willing to use a bovine plasma source product and to surgery and clinical sites that are not currently using bovine Thrombin because it has not been made available to them due to market demand.

"We think there is a somewhat unquantifiable, at this point, increase in the market that's possible by bringing a new product to market in this phase," Williams said during his presentation.

The company also believes that it will be able to justify a pricing premium, due to the better safety profile and lack of a black box warning.

"We see the opportunity for additional expansion as we move into markets that aren't currently using Thrombin and the potential for rapid market conversion," Williams said.

ZymoGenetics is also taking steps to build its sales and marketing infrastructure for recombinant human Thrombin, and the company plans to have 30 to 50 sales representatives for the product.

"This is going to be a significant year for us, especially in the Thrombin program," Williams said.

Additional data coming

Williams also said Tuesday that ZymoGenetics plans to report data from a recently completed double-blind placebo controlled phase 1 clinical trial of TACI-Ig in rheumatoid arthritis at the European League Against Rheumatism conference on June 23.

"We were very encouraged by the data we have accumulated thus far," Williams said.

The company will also have data coming from a phase 1 study of TACI-Ig for lupus, he said.

ZymoGenetics is a biopharmaceutical company based in Seattle that discovers, develops and commercializes therapeutic proteins for the prevention or treatment of human diseases.

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