Omrix Biopharmaceuticals Inc., a commercial-stage biopharmaceutical company that develops and markets biosurgical and antibody-based products, has filed an Investigational New Drug (IND) application with the US 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 per cent 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 gynaecology 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 US 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 CEO. "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 commercialised products."