Orgenesis Establishes Belgium Subsidiary for Manufacturing Process Development of Clinical Grade Cells
November 05 2013 - 8:31AM
Marketwired
Orgenesis Establishes Belgium Subsidiary for Manufacturing Process
Development of Clinical Grade Cells
WHITE PLAINS, NY--(Marketwired - Nov 5, 2013) - Orgenesis, Inc.
(OTCQB: ORGS), a development-stage company with a novel
regenerative medicine technology that converts a diabetes patient's
liver cells into functioning insulin-producing cells, has
established and registered a subsidiary in Belgium, named Orgenesis
SPRL, to complete process development and enable product
manufacturing of cells to be used for clinical trials in
Europe.
The incorporation of Orgenesis SPRL follows a partnership
established in May 2013 with ATMI, Inc (NASDAQ: ATMI) for the
Integrity® Xpansion™ disposable bioreactors from ATMI LifeSciences
to become a major component in Orgenesis' cell culture product
manufacturing. Prior to establishing Orgenesis SPRL, Orgenesis
began working with key CMOs (contract manufacturing organizations)
in Belgium's Walloon region in order to develop a
commercially-scalable manufacturing process. The Walloon region has
become a central hub to innovative companies addressing new
technologies for cell therapy.
Orgenesis will continue to collaborate with ATMI and other
partners in the region to complete tech transfer from their R&D
Operations in Tel Aviv and further automate its cell manufacturing
process.
"Our recently submitted request to the subsidy program of the
Walloon region for funding 70% of Orgenesis SPRL activity until
clinical studies commence makes Belgium a natural choice for our
cell manufacturing process development activities," said Sav
DiPasquale, Chief Executive Officer of Orgenesis. "This initiative
geographically aligns our efforts with key partners such as ATMI
LifeSciences, and is expected to facilitate our European clinical
trial design, enrollment and overall program progression."
About Orgenesis Inc. Orgenesis (ORGS) is a development stage
company with a novel therapeutic technology that employs a
molecular and cellular approach directed at converting a patient's
own liver cells into functional insulin producing cells, as a
treatment for diabetes. Orgenesis believes that converting the
diabetic patient's own tissue into insulin-producing cells
overcomes the problem of donor shortage and removes the risk of
transplant rejection. If successful, this could mean the end of
diabetes, as we now know it. For more information visit:
www.orgenesis.com.
About ATMI
ATMI, Inc. provides specialty semiconductor materials, and safe,
high-purity materials handling and delivery solutions designed to
increase process efficiencies for the worldwide semiconductor, flat
panel, and life sciences industries. For more information, please
visit http://www.atmi.com.
About ATMI LifeSciences
ATMI LifeSciences is an acknowledged technology leader in the
field of single-use bioprocess systems and consumables for the
pharmaceutical and biopharmaceutical industries. Its innovative,
market-leading portfolio of custom-engineered, flexible packaging
solutions, single-use storage systems, mixers and bioreactors is
driving bioprocess efficiency and delivering value for
biopharmaceutical companies around the world. For more information,
go to www.atmi-lifesciences.com.
ATMI, Integrity and Xpansion are trademarks, or registered
trademarks, of Advanced Technology Materials, Inc., in the United
States, other countries or both.
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" which
are not purely historical. Such forward-looking statements include,
among other things, the expectations of management that our
regeneration technology can be developed as therapeutic treatment
for diabetes which could, if successful, mean the end of diabetes
as we know it; that we have an advantage over competitors with our
approach to treating diabetes; Orgenesis will continue to
collaborate with ATMI and other partners in the region to complete
tech transfer from their R&D Operations in Tel Aviv and further
automate its cell manufacturing process; and the expectation of the
acceleration of Orgenesis' European clinical trial design,
enrollment and overall program progression. No assurance can be
given that any of the events anticipated by the forward-looking
statements will occur or, if they do occur, what benefits Orgenesis
will obtain from them. Actual results could differ from those
projected in any forward-looking statements due to numerous
factors. Such factors include, among others, the inherent
uncertainties associated with new projects and development stage
companies, which include, without limitation, the potential failure
of development candidates to advance through preclinical studies or
demonstrate safety and efficacy in clinical testing and the ability
to pass clinical trials so as to move on to the next phase;, our
ability to retain key employees; our ability to finance development
or satisfy the rigorous regulatory requirements for new medical
procedures; and competitors may develop better or cheaper
alternatives to our products. These forward-looking statements are
made as of the date of this news release, and we assume no
obligation to update the forward-looking statements, or to update
the reasons why actual results could differ from those projected in
the forward-looking statements. Investors should refer to the risk
factors disclosure outlined in our periodic reports filed from
time-to-time with the Securities and Exchange Commission.
Company Contact: Sav DiPasquale President & Chief Executive
Officer 416-509-9832 sav.d@orgenesis.com Investor Relations: Chris
Tyson Liolios Group, Inc. Tel (949) 574-3860 ORGS@liolios.com
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