Washington Editor

The FDA gave its nod of approval to Omrix Biopharmaceutical Inc.'s Evithrom, the first standalone human thrombin product approved since 1954 and the only such product with U.S. licensing.

Evithrom, derived from human plasma obtained from screened and tested U.S. donors, is a topical product indicated for use in general surgery procedures to control minor bleeding from capillaries and small veins.

The product, manufactured in Israel, will be distributed by Johnson & Johnson Wound Management, a division of Somerville, N.J.-based Ethicon Inc., which is marketing the product in the U.S.

Evithrom will be available in U.S. hospitals and surgery centers during the fourth quarter of 2007, Omrix's Chief Financial Officer Michael Burshtine told BioWorld Today.

Omrix's competitor in the thrombin market, ZymoGenetics, which expected to hear an approval decision by Oct. 18, about its recombinant human thrombin product rThrombin, was told by regulators last week that the FDA was extending its review until Jan. 17. That news sent ZymoGenetic's (NASDAQ:ZGEN) stock tumbling.

On the news of Evithrom's approval, shares of Omrix (NASDAQ:OMRI) rose $4.89, or nearly 17 percent, while ZymoGenetic's stock fell $0.42 or 3.45 percent at the end of trading yesterday.

Shares of Bristol-Tenn.-based King Pharmaceuticals (NYSE:KG), which markets a bovine-derived thrombin product called Thrombin-JMI, also dropped $0.57, or 3.64 percent.

New York-based Omrix submitted a biologics license application to the FDA in November 2006 after results of a Phase III clinical trial showed that Evithrom was comparable to bovine-derived thrombin in safety and efficacy in achieving hemostasis in general surgery procedures.

The multicenter, prospective, double-blind, randomized, controlled study was conducted at 22 U.S. sites in 305 patients undergoing cardiovascular, spine, or general surgeries or posttraumatic procedures.

The study met its primary endpoint with both human and bovine thrombin achieving hemostasis within 10 minutes 97.4 percent of the time, according to Omrix. The incidence of hemostasis within 10 minutes was similar in both treatment groups.

But, Burshtine maintained, the human thrombin product has a safer immune-response profile than the bovine-derived product.

The approval of Evithrom, Burshtine said, puts Omrix closer to its goal of being the "one-stop-shop" in the U.S. for surgical hemostat products.

He noted that the firm also makes Evicel fibrin sealant, a combination of human thrombin and a concentrate of human fibrinogen, known as biological active component 2. Evicel, first approved in the U.S. in 2003 and formerly marketed under the brand name Crosseal, is indicated as an adjunct to hemostasis for use in patients undergoing liver or vascular surgery, when control of bleeding by standard surgical techniques is ineffective or impractical.

Omrix is seeking FDA approval of the product for use in general surgery procedures, Burshtine noted.

Omrix, in collaboration with Ethicon, is also developing a fibrin patch product for rapid control of severe bleeding during surgical procedures.

The fibrin patch, Burshtine said, is currently being tested in a Phase I trial in Israel. The firm expects to submit an investigational new drug application to FDA by the end of the year to test the product in the U.S., he added.

Omrix expects to market the fibrin patch in the U.S. by 2010, Burshtine said.