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Teva takes option to commercialize Gamida-Cell's Stem-Ex

StemEx is a stem-cell derived treatment for leukemia and lymphoma. Teva will invest up to $25 million.

Globes correspondent
16 Feb 05 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and Gamida-Cell Ltd. announced today that Teva has exercised the option to enter into a joint venture with Gamida-Cell Ltd. The two companies will develop and commercialize Gamida-Cell's StemEx for the treatment of leukemia and lymphoma.

As part of its investment in Gamida-Cell in 2003, Teva held an option to jointly complete the development and globally commercialize StemEx. Teva will invest under certain conditions up to $25 million in the joint venture.

Currently, only 15% of patients requiring bone marrow transplantation, who do not have genetically matched relatives, are able to find matching donors. StemEx, which is based on inventions made in the Hadassah hospital in Jerusalem, is cord blood highly enriched with stem cells.

According to Gamida-Cell, StemEx has the potential to fulfill a life saving unmet need for the majority of the patients who cannot find matching donors. This was shown by data from the recent Gamida-Cell Phase I/II study presented at the annual conference of the American Society for Hematology (December 2004).

Teva president and CEO Israel Makov said, "The investment and exercise of the option with Gamida-Cell are part of Teva's strategy to enter into the field of cell therapy. As part of this strategy Teva led the Israeli cell therapy consortium 'Genesis,' and in addition to Gamida-Cell, invested in Proneuron, an Israeli company developing cell-based therapies for complete spinal cord injury. Teva believes in the potential of cell therapy and is committed to bringing to the world market new therapies based on Israeli science."

Teva and Gamida plan to meet the Food and Drug Administration and other regulatory agencies in order to finalize the parameters for the pivotal study. The companies hope to initiate this study in the second half of 2005.

Gamida-Cell CEO Ehud Marom said, "It is our intention to begin the pivotal Phase II/III study of StemEx and secure fast track designation".

Gamida-Cell deals in the expansion of hematopoietic (blood) stem cell therapeutics in clinical development for cancer and autoimmune diseases, as well as future regenerative cell-based medicines including cardiac and pancreatic repair. Major shareholders are Elscint (Europe-Israel), Biomedical Investments, Denali Ventures, Teva, Auriga Ventures, Pamot and Comsor.

Published by Globes [online], Israel business news - www.globes.co.il - on Wednesday, February 16, 2005


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