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news.Teva Pharmaceutical Industries and Gamida-Cell have entered into a joint venture to develop and commercialize their stem cell therapeutic, StemEx, for the treatment of leukemia and lymphoma.
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As part of the 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.
StemEx, which was developed by Gamida-Cell based on inventions made in the Hadassah hospital in Jerusalem, has shown, in a phase I/II study, the potential to fulfill a life saving unmet need for the majority of patients who cannot find matching donors.
“The investment and exercise of the option with Gamida-Cell are part of Teva’s strategy to enter into the field of cell therapy,” said Israel Makov, Teva’s president and CEO. “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 FDA and other regulatory agencies in order to finalize the parameters for a pivotal phase II/III study. The companies hope to initiate this study in the second half of 2005.