Healthcare Industry News: Integrated BioPharma
News Release - May 8, 2014
MediWound Expands Distribution of NexoBrid to Russia Through Agreement With Genfa MedicaYAVNE, Israel, May 8, 2014 -- (Healthcare Sales & Marketing Network) -- MediWound Ltd. (MDWD), a fully-integrated, biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, announced today the signing of an agreement granting Genfa Medica, S.A. exclusive rights to market and distribute NexoBrid(R) in Russia for the treatment of severe burns. Approximately 35,000 patients with severe burns are hospitalized every year in Russia at approximately 80 burn centers.
NexoBrid is an easy-to-use, topically-applied pharmaceutical product that removes dead or damaged tissue, known as eschar, in approximately four hours without harming the surrounding healthy tissue. This innovative treatment for severe burns received marketing authorization from the European Medicines Agency for the removal of eschar in adults with deep partial and full-thickness thermal burns, and was commercially launched in Europe in December 2013. Sales of NexoBrid in Russia will not commence until after receipt of local regulatory approval, which may take a year or more to be granted.
In addition to this agreement in Russia, in February 2014 the Company executed an exclusive distribution agreement for NexoBrid to treat severe burns in Argentina with Tuteur S.A.C.I.F.I.A.
"We are delighted to partner with Genfa Medica to bring NexoBrid to patients in Russia who are suffering from severe burns. We know that the Genfa Medica team is well-regarded within the medical community they serve. As such, we believe they will be a good partner for our efforts to expand internationally our support to burn specialists and their teams, entrusted with the care of burn patients in Russia. We believe that Genfa Medica's innovative marketing experience will play a key role in accelerating adoption of NexoBrid in Russia, our first market in Eastern Europe. We are confident that this collaboration will substantially expand patient access to the important clinical benefits of NexoBrid," stated Gal Cohen, President and Chief Executive Officer of MediWound.
"We launched NexoBrid in Europe last December, beginning with Germany, and are pleased with the initial positive feedback we are receiving from burn specialists using NexoBrid to rapidly remove eschar to facilitate the timely, direct visualization and assessment of the wound bed and reduce the surgical burden on their patients. We are working closely with burn centers in Germany and expect to expand such cooperation to major burn centers throughout Europe by the end of the year," he added.
NexoBrid is an easy-to-use, topically-applied product that removes dead or damaged tissue, known as eschar, in approximately four hours without harming the surrounding healthy tissues. NexoBrid received marketing authorization from the European Medicines Agency for the removal of eschar in adults with deep partial and full-thickness thermal burns, and was commercially launched in Europe in December 2013. Representing a new paradigm in burn care management, NexoBrid demonstrated in clinical studies, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier than other modalities, without harming viable tissues. The removal of eschar or "debridement" is a critical first step in the successful healing of severe burns and chronic and other hard-to-heal wounds. With the current standard of care, burn eschar is removed either with existing topical agents that have been found to be minimally effective or that take a significantly longer period of time to work, or by resorting to non-selective surgery, which is traumatic and may result in loss of blood and viable tissue necessitating further surgical treatments.
About Genfa Medica, S.A.
Genfa Medica S.A. is a Swiss company representing pharmaceutical manufacturers from Argentina, Israel and Canada to the Russian pharmaceutical market. Its broad portfolio of high-quality prescription products is used mostly in reimbursed and hospital segments. According to IMS, three brands sold by Genfa Medica S.A. have been nominated leaders with the highest sales in the Russian reimbursement market: Genfaxon, Genfatinib and Tutabin. The Association of International Pharmaceutical Manufacturers (AIPM) recently published their ranking of the Top 10 pharmaceutical companies in the Russian reimbursement market in 2013 by market share, in which Genfa Medica S.A. ranked fifth. (Reference: Remedium Market Bulletin, February 2014.)
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 U.S. 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 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.
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