European Medicines Agency (EMA) Waives Requirement to Test StemEx(R) in Paediatric Patients 17 Years of Age and Under

By Gamida Cell Ltd., PRNE
Sunday, January 17, 2010

The International Study of StemEx, an Experimental Treatment for Leukemia, Lymphoma and MDS, is now Enrolling at Clinical Sites in Italy, Hungary, Spain, Israel and the U.S.

JERUSALEM, Israel, January 18 - The Gamida Cell-Teva Joint Venture (JV) announced today that the
Paediatric Committee (PDCO) of the EMA has granted product specific waivers
for StemEx for all subsets of the paediatric population (birth to 17 years of
age) in all conditions. The PDCO emphasized that the granting of the waivers
should not prevent the JV from considering developing StemEx for children
with conditions where there is a need. StemEx is being developed by a joint
venture equally owned and operated by Gamida Cell and Teva Pharmaceuticals
(NASDAQ: TEVA).

In order to register a new medicinal product in the European Union, a
company generally needs to clinically prove efficacy and safety in paediatric
patients in addition to adults. Moreover, a company has to submit to the PDCO
a Paediatric Investigational Plan (PIP) for the four existing paediatric age
subsets which cover from birth to 17 years of age. The JV submitted a PIP for
the age group 12 -17 together with product specific waiver requests for the
three age groups between birth to 11 years of age.

As the added value of StemEx lies primarily in the treatment of larger
children and adult patients, the PDCO waiver is congruent with the JV's
strategy to develop StemEx initially for adolescents and adults.

Ms. Michal Austin, director of regulatory affairs said, "It is well known
that the limited number of stem cells in cord blood inhibits the therapeutic
use of cord blood transplantation in adolescents and adults. Gamida Cell's
technology takes this small population of cord blood stem cells and cultures
it with limited differentiation, to a size that has the potential to offer a
therapeutic treatment to larger children and adults. Thus, the goal of the JV
is for StemEx to significantly widen the scope of a base treatment, already
common practice in children. As such, we believe, and the Agency has agreed,
that our first priority in developing StemEx will be to offer the treatment
to those patients with the most unmet clinical need, meaning adolescents and
adults. This means, we are still on track for a 2011 market launch."

Gamida Cell is currently enrolling for the study of StemEx as an
investigational treatment for adolescents (larger children) and adults with
leukemia at leading cord blood transplant clinical sites in Italy, Hungary,
Spain, Israel and the U.S. For more information about the study:
www.stemexstudy.com.

About Gamida Cell

Gamida Cell Ltd. is a world leader in stem cell expansion technologies
and therapeutic products. The company is developing a pipeline of products in
stem cell transplantation and in tissue regeneration to effectively treat
debilitating and often fatal illnesses such as cancer, hematological,
autoimmune and ischemic diseases. Gamida Cell's therapeutic candidates
contain populations of adult stem cells, selected from non-controversial
sources such as umbilical cord blood and bone marrow, which are expanded in
culture. Gamida Cell was successful in translating these proprietary
expansion technologies into robust and validated manufacturing processes
under GMP. Gamida Cell's flagship product, StemEx, is now being studied as a
therapy for patients with blood cancers in an international pivotal trial at
leading transplant centers in the U.S., Europe and Israel. StemEx has orphan
drug designation in the U.S. and in Europe. Gamida Cell's current
shareholders include: Elbit Imaging, Biomedical Investment, Israel Healthcare
Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga
Ventures. For more information, please visit: www.gamida-cell.com.

    Press contact:

    Marjie Hadad
    Media Liaison/IR
    Gamida Cell
    marjie@gamida-cell.com
    +972-54-536-5220

Press contact: Marjie Hadad, Media Liaison/IR, Gamida Cell, marjie at gamida-cell.com, +972-54-536-5220

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