Healthcare Industry News: Integrated BioPharma
News Release - July 6, 2007
OMRIX Biopharmaceuticals Receives Food and Drug Administration (FDA) Approval to Use Cryoprecipitate from Talecris Biotherapeutics, Inc. in Its Manufacturing ProcessNEW YORK--(HSMN NewsFeed)--OMRIX Biopharmaceuticals, Inc. ("OMRIX" or the "Company") (NASDAQ: OMRI ), a fully-Integrated BioPharmaceutical company that develops and markets protein-based biosurgery and passive immunotherapy products, announced today that on July 3, 2007, the U.S. Food and Drug Administration, or FDA, approved the Company's use of Cryoprecipitate ("cryo") from Talecris Biotherapeutics, Inc. ("Talecris"). Cryo is a plasma fraction containing coagulation proteins and the raw material from which OMRIX manufactures BAC, the fibrinogen component of its marketed fibrin sealants, Evicel and Quixil, and Fibrin Patch product candidate.
"We are happy to announce the achievement of this long-awaited milestone," stated Robert Taub, President and Chief Executive Officer. "Utilizing cryo in our manufacturing process will allow OMRIX to lessen its dependence on plasma and in the long-run, realize better gross margins."
The Company anticipates that the receipt of the cryo approval will enable it to imminently ship substantial quantities of Evicel to Ethicon, a Johnson & Johnson company, of which the Company had expected to ship approximately $1.0 million in the second quarter of 2007 (2Q07).
On October 11, 2006, OMRIX announced a long term supply agreement with Talecris for cryo whereby OMRIX committed to certain minimum purchases and obtained a right of first refusal to additional supply of cryo.
About OMRIX Biopharmaceuticals, Inc.
OMRIX Biopharmaceuticals is a fully-Integrated BioPharmaceutical company developing and marketing protein-based biosurgery and passive immunotherapy products. OMRIX' biosurgery product line includes products and product candidates that are used for the control of bleeding, or hemostasis, and other surgical applications. OMRIX' novel Fibrin Patch, a biological-device convergence product candidate, addresses severe bleeding, an unmet medical need. The Company's passive immunotherapy product line includes antibody-rich products and product candidates for the treatment of immune deficiencies, infectious diseases and potential bio-defense applications. 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 Form 10-K as filed with the Securities and Exchange Commission on March 13, 2007 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
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