Jerusalem, Israel, March 15, 2005--- Gamida Cell (www.gamida-cell.com), a leader in the development of stem cell expansion products, announced today the appointment of Dr. Yael Margolin as the Company’s new President and CEO. Dr. Margolin has been serving on the Board of Directors of Gamida Cell since 2000.
Prior to joining Gamida Cell, Dr. Margolin served as the Vice President of Denali Ventures LLC, where she was responsible for investments in pharmaceutical and biotechnology companies and served on several Boards of Directors. Dr. Margolin also spent seven years at Teva Pharmaceuticals, where she was responsible for new product initiatives, evaluation of investment opportunities for the R&D division, and multiple drug development programs.
“We are pleased that Dr. Margolin has chosen to accept the appointment of CEO. Her scientific background coupled with her savvy business finesse are sure to serve Gamida Cell well,” said Mr. Mordechay Zisser, of Elscint/Europe-Israel (ELT), a major shareholder of Gamida Cell, and a member of the Gamida Cell Board of Directors.
Gamida Cell also announced today that the FDA has granted orphan drug designation to the Company’s flagship product StemEx® for use as hematopoietic support in patients with relapsed or refractory hematologic malignancies (cancer of the blood system) who are receiving high dose therapy.
An orphan drug status is granted by The FDA Office of Orphan Products Development (OOPD) (http://www.fda.gov/orphan/oda.htm) to promote the development of products that demonstrate promise for the treatment of rare diseases or conditions. Orphan drug designation provides for various regulatory and economic benefits, including seven years of market exclusivity in the U.S. to the first entity that obtains marketing approval in the designated indication.
“Gamida Cell is moving forward quickly and confidently to develop products that will make a significant difference in the clinical practice of modern medicine. In addition, the Company recently gained the continued support of our partner TEVA, which is to invest $25 million in a joint venture with Gamida Cell to develop and market StemEx®. We plan to begin a pivotal trial of StemEx® during 2005,” said Dr. Margolin.
“Indeed, we are delighted to have Dr. Margolin at the helm. We are looking forward to the great milestones this new CEO is certain to achieve. We are also pleased that former CEO Mr. Ehud Marom will continue to play a role in the future of the Company by continuing on as a member of the Board,” said Mr. Ruben Krupik, Managing Director of Biomedical Investments and on the Board of Directors of Gamida Cell.
Gamida Cell Ltd. (www.gamida-cell.com) is a leader in the expansion of hematopoietic (blood) stem cell therapeutics in clinical development for cancer, as well as future regenerative cell-based medicines including cardiac, pancreatic and neurological repair and autoimmune diseases. Following the presentation of the results of the Company’s Phase I/II study of StemEx® for the treatment of hematological malignancies at ASH 2004, Gamida Cell is now pushing for approval based on pivotal studies planned for 2005 with fast track designation. Plans are also underway to begin a Phase I/II clinical trial in a cardiac repair indication, in 2005. In addition, pre-clinical studies show that the Company’s expanded population of stem cells reverses diabetes. The combined market potential of Gamida Cell’s stem cell expansion products is estimated at $40 billion worldwide. This includes products based on stem cells from umbilical cord blood as well as placenta, bone marrow, peripheral blood and adult organs like the liver, heart, skin, neural and pancreatic tissues . Gamida Cell is currently pursuing partnerships, joint ventures and/or strategic alliances. Investors include Elscint (Europe-Israel), Biomedical Investments, Denali Ventures, Teva, Auriga Ventures, Pamot and Comsor.
For additional information or to schedule an interview with the CEO, please contact Marjie Hadad, Media Liaison, Marjie@gamida-cell.com; +972-54-536-5220.