OMRIX Biopharmaceuticals Files Investigational New Drug (IND) Application For Anti-Adhesion Product

December 27, 2006 07:10 AM Eastern Time
OMRIX Biopharmaceuticals Files Investigational New Drug (IND) Application For Anti-Adhesion Product Candidate and Announces Recent Milestone Achievements
NEW YORK--(BUSINESS WIRE)--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 filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its Anti-Adhesion product candidate and achieved several milestones in the fourth quarter of 2006.
OMRIX’ Anti-Adhesion product candidate, Adhexil, is based on the Company’s fibrin sealant platform and is intended for use as a barrier substance to prevent post-operative adhesions. These adhesions have been shown to develop in up to 93% of patients following various surgical procedures, including pelvic, abdominal and cardiac surgery. Adhexil, once applied under minimally invasive procedures, forms a physical barrier preventing adhesions of the operated tissues. During the operation, the product is sprayed onto surfaces most at risk of forming adhesions. This coats and protects the tissues from post-operative adhesions. After the surgical wounds heal, the fibrin barrier is naturally absorbed.
Initially, OMRIX is targeting the laparoscopic gynecology market. Laparoscopic surgery is becoming more extensive and popular and the Company believes Adhexil’s competitive advantage is the product’s ability to be applied laparoscopically in the presence of bleeding. OMRIX intends to launch Adhexil in the EU and the U.S. in 2009.
“We are pleased to end 2006 with the filing of an IND for our anti-adhesion product and confirm the achievement of several milestones we previously stated would occur before year end,” stated Robert Taub, OMRIX’ President and Chief Executive Officer. “Adhexil is one example of how we are expanding our product pipeline beyond current indications and diversifying our distribution channels. We look forward to 2007 as we continue to rapidly advance our development pipeline and expand the market presence of our commercialized products.”
In addition, OMRIX achieved the following milestones in the fourth quarter of 2006: 1) Completed patient enrollment in the West Nile Virus (WNV) Phase
1/2 clinical trial. The clinical trial includes a three month
follow up.
2) Completed the high titer vaccinia immunoglobulin (HT-VIG)
preclinical studies.
3) Completed patient enrollment in the Evicel Phase 3 clinical
trial in kidney surgery, the last clinical trial needed to file
for a general hemostasis indication with the FDA.
About Adhexil
Adhexil is designed to be non-reactive but protective to tissue at adhesion risk during the critical wound healing period before being reabsorbed and cleared. It is designed to remain adherent to the target tissue and should be easily applied during laparoscopic procedures performed on adhesiogenic organs such as ovaries.
About WNIG
OMRIX’s West Nile Immunoglobulin, or WNIG, derived from human plasma, is intended to provide effective treatment to patients with or at high risk for progression to WNV encephalitis and/or myelitis. Currently, there are no licensed therapies available to treat WNV infection.
About HT-VIG
Based on pre clinical data, HT-VIG is a more potent form of OMRIX’s Vaccinia Immunoglobulin (VIG) product and is intended to be used in smaller volumes than existing VIG preparations for the same indication. The smaller volume of HT-VIG is designed for rapid deployment by medical personnel to treat more patients in urgent situations.
About Evicel
OMRIX is expending the indications for its second generation fibrin sealant, Evicel™, in collaboration with Ethicon, a Johnson & Johnson company. OMRIX is seeking to obtain approval for Evicel™ as an adjunct to hemostasis for general surgical use in the U.S. and the EU. Evicel is unique in its ease of use, immediate availability to the surgeon and its bovine-free formulation. It provides for important hemostasis support when conventional surgical techniques (i.e., suture, ligature, and cautery) prove to be inefficient, ineffective or impractical. The Phase 3 clinical trial in kidney surgery is the last of three clinical trials required from Omrix to file for a general hemostasis indication with the FDA. The anticipated FDA approval of a kidney indication will trigger the general hemostasis indication approval, which means that the Ethicon sales force will be able to market the product for use in any type of surgery where fibrin sealants are applicable for use.
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 registration statement as filed with the Securities and Exchange Commission on December 14, 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.
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