Gamida Cell Announces Investment and Option Agreement with Major Pharmaceutical Company

       Gamida Cell Announces Investment and Option Agreement with Major
                            Pharmaceutical Company

PR Newswire

JERUSALEM, August 19, 2014

JERUSALEM, August 19, 2014 /PRNewswire/ --

Gamida Cell, a world leader in stem cell expansion technologies and
therapeutic products, announced today that it has signed an investment and
option agreement with Novartis Pharma AG("Novartis"). According to the
agreement, Novartis will invest $35 million in Gamida Cell and in return will
receive 15% equity and an option to fully acquire Gamida Cell. The option is
exercisable for a limited period of time following achievement of certain
milestones connected to the development of NiCord^®, anticipated to be met
during 2015. Completion of the transaction is subject to customary closing
conditions.

 (Logo: http://photos.prnewswire.com/prnh/20140819/702604 )

Upon exercising the Option, Novartis would pay the other shareholders in
Gamida Cell (the Sellers) cash payments of approximately $165 million, in
accordance with the terms of the Agreement. In addition, the Sellers will be
entitled to potential future payments which can reach a total of $435 million,
depending on certain development and regulatory milestones and on sales of
Gamida Cell's products.

Gamida Cell president and CEO Dr. Yael Margolin said, "The investment and
option agreement announced today demonstrates Novartis' belief in the
potential of Gamida Cell's platform technology, product pipeline and team.
Novartis is a leading pharmaceutical company with a declared commitment to
further expand and develop its pipeline of cell therapy products. This,
combined with the breadth of its resources and experience, positions Novartis
perfectly for an alliance with Gamida Cell."

Gamida Cell chairman of the board and Clal Biotechnology Industries' CEO Mr.
Ruben Krupik said, "Every company experiences successes and challenges during
the course of its evolution. It is the ones with particularly brilliant
scientists and astute management teams that are able to successfully persevere
to bring good products to the market. We believe that Gamida Cell is in this
category. The investment and option agreement with Novartis could bring the
company a significant step closer to this important goal." 

Gamida Cell is currently engaged in a Phase I/II study of NiCord^® 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. NiCord^® is derived from a single cord blood unit and expanded
and enriched with stem cells using Gamida Cell's proprietary NAM technology. 

In a standard individual cord blood unit, the limited number of stem cells
compromises successful engraftment in an adult patient. To circumvent this
obstacle, physicians currently provide patients with two cord blood units to
achieve therapeutically meaningful cell numbers. The positive clinical results
of a Phase I/II clinical study using a double cord protocol, NiCord^® (the
expanded cord blood unit) along with an un-manipulated unit, showed early and
durable engraftment with the un-manipulated unit disappearing in most of the
patients.

These results were the basis for studying NiCord^® as a 'single' expanded unit
without co-infusion of a second un-manipulated cord. NiCord^® may provide a
single unit of expanded cord blood with clinical results comparable to those
seen in a double cord setting, thus introducing a paradigm shift in treatment
practice. The current Phase I/II single cord study of NiCord^®, the first of
its kind, is soon to be followed by a Phase III study planned to begin at the
end of 2015. 

Additionally, recruitment continues for Gamida Cell's Phase I/II study of
NiCord for pediatric sickle cell disease.  SCD affects 90,000 to 100,000 in
the US alone. Symptoms range in type and severity. However, SCD can be fatal.
To date, the only known cure for SCD is stem cell transplantation from a
family related matched donor.

About Gamida Cell 

Gamida Cell is a world leader in stem cell population expansion technologies
and stem cell therapy products for transplantation and regenerative medicine.
The company's pipeline of stem cell therapy products are in development to
treat a wide range of conditions including blood cancers, solid tumors,
non-malignant hematological diseases such as sickle cell disease and
thalassemia, neutropenia and acute radiation syndrome, autoimmune diseases and
genetic metabolic diseases as well as conditions that can be helped by
regenerative medicine. Gamida Cell's therapeutic candidates contain
populations of adult stem cells, selected from non-controversial sources such
as umbilical cord blood, bone marrow and peripheral blood, which are expanded
in culture. Gamida Cell's current shareholders include: Elbit Imaging (NASDAQ:
EMITF), Clal Biotechnology Industries (TASE: CBI), Israel Healthcare Venture,
Teva Pharmaceutical Industries (NASDAQ: TEVA), Amgen (NASDAQ: AMGN), Denali
Ventures and Auriga Ventures. For more information please visit
http://www.gamida-cell.com.

Forward looking statement

All forward-looking statements in this announcement are based on information
available to Gamida Cell as of the date hereof and Gamida Cell cannot
guarantee such statements will materialize. Gamida Cell does not assume any
obligation to update the forward-looking statements provided to reflect events
that occur or circumstances that exist after the date on which they were made
or to update the reasons why actual results could differ materially from those
anticipated in the forward-looking statements, even if new information becomes
available in the future.

Press contact:
Marjie Hadad
MH Communications
marjie@netvision.net.il
marjie@gamida-cell.com
+972-54-536-5220

SOURCE Gamida Cell
 
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