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May 25, 2015 4:51 PM ET

Biotechnology

Company Overview of Gamida Cell Ltd.

Company Overview

Gamida Cell Ltd. develops stem cell expansion technologies and therapeutic products to treat cancer, cardiac, and peripheral vascular diseases. It develops StemEx for leukemia and lymphoma; MetCord for metabolic and storage diseases, such as krabbe disease, metachromatic leukodystrophy, and hurler syndrome; and NiCord, an expanded cell graft derived from a unit of umbilical cord blood enriched with stem cells for conditions that are curable with bone marrow transplantations, including hematological malignancies/blood cancer, sickle cell disease, thalassemia, severe autoimmune diseases, and metabolic diseases. The company also develops CardioCure, a cell-based autologous bone marrow product, ...

Nahum Hafzadi 5 Street

Givat Shaul

Jerusalem,  95464

Israel

Founded in 1998

Phone:

972 2 659 5666

Fax:

972 2 659 5616

Key Executives for Gamida Cell Ltd.

Chief Executive Officer, President and Director
Co-Founder, Chief Scientific Officer and Vice President of Research & Development
Chief Financial Officer
Head of the Stem Cell Consortium Projects
Vice President of US Operations
Compensation as of Fiscal Year 2014.

Gamida Cell Ltd. Key Developments

Gamida Cell Announces Successful Transplantation of First Person with Cryopreserved (Frozen) NiCord® in its Ongoing Phase I/II Clinical Study for Blood Cancer Patients

Gamida Cell announced that the first person has been successfully transplanted with cryopreserved (frozen) NiCord® in the company's ongoing Phase I/II clinical study for blood cancer patients. This is the first time that a patient has been successfully transplanted with umbilical cord blood stem and progenitor cells, that were expanded (population increased) ex-vivo (outside of the body), and cryopreserved. The company also noted that after thaw, the cryopreserved product maintained the advantage of NiCord® in demonstrating very rapid engraftment (white blood cell recovery). It is expected that this rapid engraftment will reduce the risk of opportunistic infections, will lower the morbidity associated with cord blood transplantation and shorten hospitalization. Moving forward, in all ongoing and future clinical trials, NiCord® will be used only in its cryopreserved formulation. Until now, NiCord® has been transplanted as a "fresh" product that must be infused into the patient within a limited number of hours from the moment the product is released from the manufacturing site. This timetable restricted the window for transplantation for the patient. It also limited the location of manufacturing sites to the vicinity of participating medical centers and increased the cost of shipping and logistical support required from manufacturing through delivery. To overcome these limitations, Gamida Cell developed a cryopreserved formulation of the product with a long shelf life. The cryopreserved formulation of NiCord® provides several key benefits. It enables flexibility in the timing of a transplantation, which can now be determined according to the clinical conditions of the patient. If a delay is required, it is now possible and more easily managed. This flexibility in timetable also means that the product can now be distributed more efficiently and worldwide, enabling the company to expand its clinical trials to all geographic areas. NiCord® can also now be manufactured in a preferable, centralized location, which will significantly reduce the cost of goods. NiCord® is currently manufactured and shipped to the US and Europe from Gamida Cell in Jerusalem.

Gamida Cell's NiCord® Receives FDA and EMA Orphan Drug Designation

Gamida Cell, announced that orphan drug designation has been granted by The US Department of Health and Human Services, The FDA Office of Orphan Products Development (OOPD) for the investigational medicinal product NiCord® for the treatment of acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), Hodgkin lymphoma and myelodysplastic syndrome (MDS). The FDA orphan drug designation coincides with the positive opinion of the European Medicines Agency's (EMA's) Committee for Orphan Medicinal Products (COMP) regarding NiCord® as a treatment for AML. Gamida Cell intends to file for NiCord® orphan drug status with the EMA for other indications as well. The FDA and EMA grant an orphan drug designation 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. and 10 years in the EU. It is currently being tested in a Phase I/II study as an investigational therapeutic treatment for hematological malignancies such as leukemia and lymphoma. In this study, NiCord® is being used as the sole stem cell source.

Teva, Clal And Elbit Still Seek Buyer For Gamida Cell

Teva Pharmaceuticals Industries Limited (NYSE:TEVA), Clal Biotechnology Industries (TASE:CBI) and Elbit Medical Technologies Ltd. (TASE:EMTC) are still looking to sell Gamida Cell Ltd.

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