Clal Biotechnology Industries Ltd. (TASE: CBI) portfolio company MediWound Ltd. has applied to the European Medicines Agency (EMA) for marketing approval of its wound treatment drug, Nexobrid.
MediWound applied under EMA's centralized procedure for marketing approval in all 27 EU member states, without the need for filing separate applications in each country. The company expects the approval process to take about a year.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA), as part of its investment agreement in MediWound, can acquire exclusive distribution and marketing rights in the EU for MediWound's products, in exchange for predetermined investment amounts.
MediWound CEO Gal Cohen said, "Completion of development of this proprietary drug and submission for approval for commercialization in Europe is a rare event in the Israeli biomed industry. It's a great privilege to be a part of the long and complex endeavor. We've taken another great step forward on the road to international marketing of the drug, and we'll continue to work hard to complete the commercialization process of the drug."
Clal Biotech owns 55% of MediWound, which is developing treatments for burns and other chronic wounds.
Published by Globes [online], Israel business news - www.globes-online.com - on October 31, 2010
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