MediWound Ltd. reported good results of the Phase II safety clinical trial of its debrase gel dressing for the removal of burn tissue. The company also has a Phase III trial in Europe. The US Food and Drug Administration (FDA) had requested the supplementary trial to an earlier Phase II trial. The company has submitted the results of the new trial to the FDA.
MediWound's gel is used for the debriding of burns (the removal of excess tissue prior to treatment, a process currently carried out surgically), and it is also likely to be suitable for the treatment of chronic wounds.
MediWound CEO Gal Cohen said that the gel was found to be safe. The Phase II trial also confirmed earlier trials that the gel enables earlier treatment of burns by removing the eschar (dead burned tissue) within four hours instead of two days in current surgical treatments, and that the treatment is effective, in that there is no need to repeat the treatment or apply additional surgical procedures.
MediWound is owned by Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA), Clal Biotechnology Industries Ltd. (TASE: CBI), and Polar Communications Ltd. (TASE: PLRC), and others. In December 2006, the shareholders signed an agreement under which Teva would invest an initial $15 million in MediWound at a company value of $100 million, and institutional investors would invest the same amount at the same value. Sources inform ''Globes'' that that the institutional investors are Harel Insurance Investments and Financial Services Ltd. (TASE: HARL) and Migdal Insurance and Financial Holdings Ltd. (TASE: MGDL).
Teva also has an option to buy up to $100 million worth of MediWound shares in stages from the other shareholders at a company value of up to $300 million, if and when the debrase gel dressing obtains marketing approval in the Europe and subsequently in the US. If Teva exercises this option, it will own 51% of MediWound and will have marketing rights to its product for which Teva will pay royalties. The present trial is not a milestone in the agreement between the shareholders.
MediWound chairwoman Dr. Marian Gorecki and chief medical officer Prof. Lior Rosenberg founded the company in 2001. Gorecki was a founder of Biotechnology General Ltd. and Prof. Rosenberg is a burn specialist at Ben Gurion University of the Negev.
Published by Globes [online], Israel business news - www.globes-online.com - on February 3, 2008
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