MediWound Announces Successful GMP Manufacturing Audit by the Israeli Ministry of Health

By GlobeNewswire,  May 20, 2014, 08:00:00 AM EDT


YAVNE, Israel, May 20, 2014 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq:MDWD), a fully-integrated, biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, announces the successful completion of a Good Manufacturing Practice (GMP) audit of the Company's facility in Yavne, Israel by the Israeli Ministry of Health (IMOH). The audit was performed as part of the IMOH's routine evaluation of the Company's manufacturing facility for its proteolytic enzyme therapeutics.

The audit concludes that MediWound's manufacturing facility conforms to the requirements of cGMP for the manufacture of sterile and biological medicinal products. This compliance status is valid for three years from the time of the audit.

As the IMOH is also a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, this audit is also issued under the provisions of the Conformity Assessment and Acceptance of Industrial Products Agreement between the European Union and Israel.

"As a fully integrated company, manufacturing is a core competency of MediWound and is critical for our commercial success. We take great pride in maintaining the highest quality standards and this positive audit underscores the viability, quality and high standards MediWound upholds in the manufacture of our proteolytic enzyme therapeutics for commercial use and for products under development in compliance with rigorous international standards," said Gal Cohen, President and Chief Executive Officer of MediWound.

About MediWound Ltd.

MediWound is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel products to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds and connective-tissue disorders. MediWound's innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency in December 2012 for removal of dead or damaged tissue, known as eschar, in adults with deep partial- and full-thickness thermal burns. NexoBrid, which is based on MediWound's patented proteolytic enzyme technology, represents a new paradigm in burn care management, and clinical trials have demonstrated, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier upon patient admission, without harming viable tissues. For more information, please visit www.mediwound.com

Cautionary Note Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to financial results forecast, commercial results, clinical trials and the regulatory authorizations. Forward-looking statements are based on MediWound's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, unexpected results of clinical trials, delays or denial in the FDA or the EMA regulatory approval process or additional competition in the market. The forward-looking statements made herein speak only as of the date of this announcement and MediWound undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Contacts:

Sharon Malka

Chief Financial & Operation Officer

MediWound Ltd.

ir@mediwound.co.il

Anne Marie Fields

Senior Vice President

LHA

212-838-3777

afields@lhai.com

Source: MediWound

This article appears in: News Headlines

Referenced Stocks: MDWD


Latest News Video





Most Active by Volume

Company Last Sale Change Net / %
FB $ 75.32 0.34 ▲ 0.45%
SIRI $ 3.435 0.02 ▼ 0.43%
AAPL $ 97.392 0.36 ▲ 0.37%
AMD $ 3.745 0.02 ▲ 0.40%
P $ 25.52 3.20 ▼ 11.14%
F $ 17.565 0.28 ▼ 1.54%
BAC $ 15.575 0.05 ▼ 0.29%
GM $ 35 0.74 ▼ 2.07%

As of 7/25/2014, 02:09 PM