Johnson & Johnson/Omrix File Evicel sBLA For General Hemostasis In Surgery
This article was originally published in The Pink Sheet Daily
Executive Summary
Anti-bleeding product’s human serum-derived Thrombin component has a September stand-alone user fee date, Omrix tells “The Pink Sheet” DAILY.
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Omrix Biopharmaceuticals submitted a supplemental BLA March 8 to expand the indication for its second-generation liquid fibrin sealant Evicel to include general hemostasis in surgery, the company told "The Pink Sheet" DAILY. The firm requested a standard review, indicating a probable January 2008 user fee date for the expanded indication. Evicel was approved in July for use "as an adjunct to hemostasis" to control bleeding during liver surgery. Its components are derived from human plasma. Evicel is a two-part product that combines human thrombin with a "biologically active component" consisting mainly of human fibrinogen. The combination results in clots with "greater elasticity and adherence to tissue," according to Omrix. Evicel is administered via a spray applicator or by dripping. Omrix has a September user fee date for a separate BLA for the Thrombin component of Evicel as a stand-alone product for a general hemostasis indication in surgery, the company said. FDA allowed Omrix to cross reference the chemistry, manufacturing and controls and preclinical sections of its first Evicel filing for the Thrombin application. Under co-development agreements signed in 2003 and 2004, Johnson & Johnson's Ethicon subsidiary has exclusive U.S. and European Union sales and marketing rights to Omrix's hemostasis and sealing products. Ethicon pays most development costs, and Omrix receives a percentage of sales revenues. Evicel is marketed as Quixil outside the U.S. New York-based Omrix is in competition with Seattle's ZymoGenetics for the general surgical use indication with a human-based surgical fibrin sealant. ZymoGenetics announced in December that it had filed a general surgical use BLA for its rhThrombin, a recombinant human product (1 (Also see "ZymoGenetics Files Recombinant Human Thrombin BLA" - Pink Sheet, 18 Dec, 2006.)). Each company is promoting the human-based advantage of its product over the current standard, King Pharmaceuticals' Thrombin-JMI , which is derived from bovine blood. Thrombin-JMI had 2006 sales of $247 million, according to King. Omrix's sBLA filing includes the results from a prospective, randomized, multi-center Phase III controlled study that compared the hemostatic efficacy of Evicel to standard-of-care in retroperitoneal or intra-abdominal surgery in 135 patients, according to the company. The first subject was randomized in February 2006, and the last subject finished in December. The company filed a prior approval supplement with FDA at the time of the liver surgery approval containing results of another Phase III clinical study comparing Evicel to standard-of-care in peripheral vascular surgery in 150 patients. The first subject in that study was randomized in June 2005, and the last subject completed the study in March 2006. Omrix announced in December that enrollment was also completed in a Phase III trial of Evicel against standard-of-care in kidney surgery. ZymoGenetics recently announced that FDA will not require a separate Phase III trial to consider approval of a spray version of rhThrombin (2 (Also see "ZymoGenetics Sees Faster Approval Of Second rhThrombin Configuration" - Pink Sheet, 7 Mar, 2007.)). The original BLA is for a formulation that would be applied to a gelatin sponge. - Shirley Haley ([email protected]) |