Omrix Biopharmaceuticals Receives Approval from European Medicines Agency for Evicel Liquid Fibrin Sealant (Human)
14 Octobre 2008 - 1:00PM
Business Wire
OMRIX Biopharmaceuticals, Inc. (�Omrix� or the �Company�) (NASDAQ:
OMRI), a fully-integrated biopharmaceutical company that develops
and markets biosurgical and immunotherapy products, announced today
that it has received approval from the European Medicines Agency
(EMEA) for Evicel, the Company�s liquid fibrin sealant. The EMEA�s
approval permits EVICEL to be marketed in Europe under the
following indication, �As a supportive treatment in surgery where
standard surgical techniques are insufficient for improvement of
hemostasis. Evicel is also indicated as suture support for
hemostasis in vascular surgery.� EVICEL is currently marketed in
the US by Johnson & Johnson Wound Management, a division of
ETHICON, INC., a Johnson & Johnson company, with a general
hemostasis in surgery indication. With an EMEA approval, EVICEL is
licensed for marketing in the 27 countries of the European Union,
or EU. Per the terms of Omrix� and ETHICON�s supply and
distribution agreement, ETHICON has the marketing rights for the
EU. About EVICEL EVICEL� is an all-human, plasma-derived fibrin
sealant currently indicated in the US as an adjunct to hemostasis
for use in patients undergoing surgery, when control of bleeding by
standard surgical techniques is ineffective or impractical. It does
not contain aprotinin, which has been associated with adverse
health effects. EVICEL� is easy to use and readily available for
time-sensitive needs in the operating room. The product is sold as
a frozen liquid and requires less than one minute preparation time
after thawing. About Omrix Biopharmaceuticals, Inc. Omrix is a
fully integrated biopharmaceutical company that develops,
manufactures and markets 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. The
Company's passive immunotherapy product line includes antibody-rich
products and product candidates for the treatment of immune
deficiencies, infectious diseases and potential biodefense
applications. For more information, please visit www.omrix.com.
Safe Harbor Statement This news 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 Securities and Exchange
Commission (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
SEC on March 17, 2008, 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 news release.
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