This excerpt taken from the TEVA 6-K filed Oct 21, 2009.
-- Study Enrollment Completed Following Positive
-- Filing for Marketing Authorization in Europe Expected in 2010 --
Jerusalem, Israel, October 20, 2009 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that MediWound Ltd., a company in which Teva holds an 11% interest, reported positive results from a pre planned interim analysis of a phase III trial for Debrase®, an enzymatic debriding agent for burns.
MediWound reported that the phase III study with Debrase® for the treatment of burns met the two primary endpoints of the study - reduction in the percentage of wound surgically excised and reduction in the percentage of wound autografted - with statistical significance. Based on these results, and in accordance with the approved clinical study protocol and past communications with the European Medicines Agency (EMEA), MediWound announced that the study is deemed to have reached its objectives and that MediWound is permitted to stop recruitment at this time. Following the completion of a full analysis of the study, MediWound expects to submit an application for marketing authorization in Europe during 2010.
"We are delighted with the successful results of MediWound. We look forward to bringing this new treatment option to markets around the world", said Dr. Aharon Schwartz, Vice President, Teva Innovative Ventures. "MediWound is a prime example of how we broaden our innovative pipeline through licensing of promising products. Teva Innovative Ventures currently has about 20 portfolio companies. Our objective is to seek partnerships globally with companies and academic institutions with molecules in all stages of development to develop new specialty medicines and treatments."
Debrase® is an innovative product developed for the enzymatic removal of burn-injured tissue (eschar). Debrase® may present an alternative to surgery and/or the lengthy non-surgical procedures which are commonly practiced today. The selective activity of Debrase®, which removes only the eschar without harming vital tissue, also minimizes the need for additional skin grafts, allowing for potential spontaneous healing of the burn wound. If approved, Debrase® may change the standard of care for burns, offering patients, doctors, hospitals and payors a superior and more cost effective treatment option.
Debrase® was granted orphan drug status in Europe and the United States, granting marketing exclusivity for 10 and 7 years, respectively.
Teva currently holds 11% of MediWound (on a fully diluted basis) and owns the marketing rights for Debrase® in certain territories. Teva has options to expand its marketing rights for Debrase® to Europe and North America, which become exercisable upon receipt of a marketing authorization from the EMEA and the FDA, respectively. If such options are exercised, Teva can and/or may be required to purchase up to 51% of MediWound.