Clal Biotechnology Industries Ltd. (TASE: CBI) portfolio company MediWound Ltd. today announced that it has obtained positive interim results from the Phase III clinical trial of its Debrase gel dressing for the treatment of burn wounds, and applied to register the dressing with the European Medicines Agency (EMEA). The trial included 175 patients.
The trial showed statistically significant results for both primary targets: reducing the need for surgical treatment for the removal of burned tissue, and reduction in the number of skin transplants.
MediWound is preparing an application for EMEA marketing approval next year, after collating and analyzing the trial data by early 2010.
IDB Holding Corp. Ltd. (TASE:IDBH) unit Clal Biotech owns 56% of MediWound and Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) owns 11%, and has an option to increase its stake to 25% when MediWound obtains marketing certification for Debrase.
If Teva decides to increase its stake, the other investors will be granted a put option to sell shares of the company to Teva at a company valuation of $200 million, so that Teva will reach a 25% stake on a fully-diluted basis. If the other investors do not want to sell, then Teva will be granted a call option to buy the same number of shares at a company valuation of $250 million. Teva's agreement with MediWound also covers marketing of Debrase in the US, and expanding the treatment to other medical uses.
Teva Innovative Ventures VP Dr. Aharon Schwartz said, "Teva has believed in the company and its product since investing in it and acquiring the US marketing rights, as well as an option to develop and market the product in Europe and the US. These successful results are an important milestone in Teva's collaboration with Clal Biotechnology and investing in other portfolio companies that are undergoing various clinical trials."
Published by Globes [online], Israel business news - www.globes-online.com - on October 18, 2009
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