Healthcare Industry News: ETHICON
News Release - November 6, 2006
OMRIX Biopharmaceuticals Submits Biologics License Application (BLA) for Human Thrombin Stand-Alone Product
NEW YORK--(HSMN NewsFeed)--OMRIX Biopharmaceuticals, Inc. ("OMRIX" or the "Company") (NASDAQ: OMRI ), a commercial-stage biopharmaceutical company that develops and markets biosurgical and antibody-based products, announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval to market Thrombin as a stand-alone product with a general hemostasis indication in surgery.As previously disclosed, the FDA has allowed the Company to cross reference the Chemistry, Manufacturing and Controls (CMC) and preclinical sections of its Evicel file. Evicel is OMRIX's currently U.S. licensed and marketed fibrin sealant product indicated as an adjunct to hemostasis in patients undergoing liver surgery.
"The submission of our Thrombin BLA positions OMRIX one step closer to its goal of creating a one-stop-shop for surgical hemostats," stated Robert Taub, OMRIX's President and Chief Executive Officer. "Together with our partner ETHICON, we are advancing the clinical development of our Fibrin Patch for the control of brisk bleeding and are continuing to penetrate the liquid fibrin sealant market with Evicel in the U.S. and Quixil in Europe. With the addition of the Thrombin product, and the marketing strength and depth of ETHICON, we believe we can offer surgeons a broad product portfolio to achieve hemostasis in many stages and types of surgical procedures."
The BLA filing is based on, and contains data from, a multi-specialty, pivotal Phase 3 clinical trial which measured and demonstrated the equivalence of topical human thrombin to bovine thrombin in achieving hemostasis in general surgery procedures in terms of safety and efficacy.
In addition to the information disclosed in the October 16, 2006 press release and conference call, the antibody data generated in this clinical study showed that one patient who received human thrombin was considered as being positive to the product. The antibody value for this patient was just below the preset criteria for positive response. Seventeen patients who received bovine thrombin developed antibodies to bovine coagulation proteins using similar preset criteria.
About Human Thrombin
Topical human thrombin, a new, human plasma-derived concentrate of stabilized thrombin formulated with calcium chloride, is one of two components of EVICEL (formerly Crosseal®), a U.S. licensed fibrin sealant. EVICEL fibrin sealant is also marketed worldwide under the name QUIXIL®. These products have a strong record of safety. Unlike the currently available commercial bovine thrombin, no material of animal origin is present in this product. Products derived from human plasma, such as topical human thrombin, may be less immunogenic than products derived from animal sources.
About OMRIX Biopharmaceuticals, Inc.
OMRIX, a commercial-stage biopharmaceutical company, develops and markets innovative biosurgical and antibody-based products, utilizing its proprietary protein purification technology and manufacturing know-how. As part of its business strategy, OMRIX commercializes certain biosurgical products through collaborations with companies whose marketing and sales expertise are a complement to OMRIX's own areas of specialty. OMRIX' novel and easy-to-use fibrin patch, a biological-device convergence product candidate, addresses unmet medical needs. For more information, please visit: www.omrix.com.
Safe Harbor Statement
This press release contains forward-looking statements. Forward-looking statements provide the company's current expectations or forecasts of future events. Forward-looking statements include statements about the Company's expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. The company's actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the company's filings with the SEC, including sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the company's Prospectus as filed with the Securities and Exchange Commission on April 21, 2006 and the company's most recent quarterly reports on Form 10-Q and its current reports on Form 8-K. Unless required by law, the company undertakes no obligation to publicly update or revise any forward-looking statement to reflect circumstances or events after the date of this press release.
Source: OMRIX Biopharmaceuticals
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
