Gamida Cell Ltd., whose shareholders include Clal Biotechnology Industries Ltd. (CBI) and Teva Pharmaceutical Industries Ltd. (TEVA), is in talks with European regulators to define a review process for its flagship product.
The stem cells developer said the European Medicines Agency accepted a unit’s stance that positive results from the Phase III trial of its StemEx product would constitute the basis for approval, according to a statement to the Tel Aviv Stock Exchange. The unit, Gamida Cell-Teva Joint Venture, expects to release results of a 100-patient trial this year.
Efforts to advance the treatment in Europe come after a setback in talks with the U.S. Food and Drug Administration. The FDA told Gamida to update its control group in its Phase III study and that the regulator is no longer obligated to a Special Protocol Assessment, according to a Tel Aviv Stock Exchange announcement dated Aug. 20. Clal Biotechnology said Gamida will apply for StemEx approval in the U.S. in the beginning of 2013.
“The route with the FDA is not going as smoothly as they had hoped so they are seeking to advance the product with another regulator as well,” said Steven Tepper, an analyst at Harel Finance Ltd. in Tel Aviv. “They are trying a different strategy.”
Clal Biotech jumped as much as 8.1 percent, the biggest intraday increase since Sept. 24, to 12.18 shekels, before closing at 12.10 shekels. Teva fell 0.8 percent to 152.20 shekels.
The StemEx technology expands umbilical stem cells, enabling them to be used in cord blood transplants to leukemia and lymphoma patients who are unable to find bone-marrow donors. Jerusalem-based Gamida says that as many as 35,000 such patients are candidates for its technology with a market as much as $1 billion.
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