TIDMMEDG TIDMMEDU
RNS Number : 9278E
Medgenics Inc
07 June 2012
Press Release 7 June 2012
Medgenics Initiates U.S. Biopump Processing Site
Facility initially to supply EPODURE for U.S. anemia clinical
trials
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG), ("the
Company") the developer of the novel Biopump(TM) technology for the
sustained production and delivery of therapeutic proteins in
patients using their own tissue, announced today it has initiated
its first U.S. Biopump processing facility in Davis,
California.
EPODURE(TM) Biopumps for the treatment of anemia are now being
processed by the Company's contract manufacturing organization
("CMO") in a good manufacturing practice ("GMP") certified
facility. This marks the first Biopump processing site outside of
Israel, and provides Medgenics with a significant ability to
scale-up its clinical and commercial capabilities to address global
therapeutic areas such as anemia and hemophilia.
In a key "dry run" test of the production system, tissue
micro-organs were obtained and loaded into individual closed
processing chambers in Israel, and then shipped to the U.S. CMO
Biopump processing center in California. There, the micro-organs
were processed in their closed systems into fully functioning
EPODURE Biopumps, meeting the release criteria for use in human
clinical trials in the U.S. This demonstrates Medgenics' capability
to support the treatment of patients at remote clinical sites,
transporting their Biopumps to and from strategically located
processing facilities, thereby allowing for multicenter clinical
trials and practical commercial implementation.
Medgenics recently announced that it had received clearance from
the U.S. Food and Drug Administration ("FDA") for its
Investigational New Drug ("IND") application to conduct a Phase IIb
study of EPODURE for the treatment of anemia in dialysis patients
in the U.S.
"The launch of this U.S. processing facility is another
important step for advancing our U.S. clinical trials and product
commercialization. The initial processing of Biopumps in the GMP
facility of our U.S. CMO resulted in product that meets all quality
requirements for use in human clinical trials. We plan to continue
with processing additional lots of product to ensure consistency
and reliability before the U.S. clinical trial commences," stated
Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of
Medgenics. "Importantly, this U.S. GMP processing center has been
launched through an existing facility, which is much less capital
intensive and simpler to establish than typical protein production
facilities. As Medgenics grows and expands, we believe that similar
Biopump processing facilities can be easily set up in other sites
around the world."
-Ends-
About Medgenics
Medgenics is developing and commercializing Biopump(TM), a
proprietary tissue-based platform technology for the sustained
production and delivery of therapeutic proteins using the patient's
own dermal skin biopsy for the treatment of a range of chronic
diseases including anemia, hepatitis and hemophilia, among others.
Medgenics believes this approach has multiple benefits compared
with current treatments, which include regular and costly
injections of therapeutic proteins.
Medgenics has three long-acting protein therapy products in
development based on this technology:
-- EPODURE(TM) to produce and deliver erythropoietin for many
months from a single administration, has demonstrated elevation and
stabilization of hemoglobin levels in anemic patients for six to
more than 36 months in a Phase I/II dose-ranging trial, and has
received approval of a Phase IIa trial in dialysis patients due to
launch in Q2 2012 in Israel. An Investigational New Drug
application has been cleared by the FDA to initiate a Phase IIb
study to evaluate the safety and efficacy of EPODURE in the
treatment of anemia in dialysis patients in the U.S.
-- INFRADURE(TM) for sustained production and delivery of
interferon-alpha for use in the treatment of hepatitis is awaiting
final approval of two Phase I/II trials in Israel in hepatitis C,
slated to commence in Q3 2012, and is filed for Orphan Drug
Designation with the FDA to treat hepatitis D.
-- HEMODURE(TM) for sustained production and delivery of
clotting Factor VIII therapy for the sustained prophylactic
treatment of hemophilia is now in development.
Medgenics is focused on the development and manufacturing of its
innovative Biopumps, aiming to bring them to market via strategic
partnerships with major pharmaceutical and/or medical device
companies.
In addition to treatments for anemia, hepatitis and hemophilia,
Medgenics plans to develop and/or out-license a pipeline of future
Biopump products targeting the large and rapidly growing global
protein therapy market, which is forecast to reach $132 billion in
2013. Other potential applications for Biopumps include multiple
sclerosis, arthritis, pediatric growth hormone deficiency, obesity
and diabetes.
Forward-looking Statements
This release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and as that term is defined
in the Private Securities Litigation Reform Act of 1995, which
include all statements other than statements of historical fact,
including (without limitation) those regarding the Company's
financial position, its development and business strategy, its
product candidates and the plans and objectives of management for
future operations. The Company intends that such forward-looking
statements be subject to the safe harbors created by such laws.
Forward-looking statements are sometimes identified by their use of
the terms and phrases such as "estimate," "project," "intend, "
"forecast," "anticipate," "plan," "planning, "expect," "believe,"
"will," "will likely," "should," "could," "would," "may" or the
negative of such terms and other comparable terminology. All such
forward-looking statements are based on current expectations and
are subject to risks and uncertainties. Should any of these risks
or uncertainties materialize, or should any of the Company's
assumptions prove incorrect, actual results may differ materially
from those included within these forward-looking statements.
Accordingly, no undue reliance should be placed on these
forward-looking statements, which speak only as of the date made.
The Company expressly disclaims any obligation or undertaking to
disseminate any updates or revisions to any forward-looking
statements contained herein to reflect any change in the Company's
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.
As a result of these factors, the events described in the
forward-looking statements contained in this release may not
occur.
For further information, contact:
Medgenics, Inc. Phone: +972 4 902 8900
Dr. Andrew L. Pearlman
andrew.pearlman@medgenics.com
LHA Phone: 212-838-3777
Anne Marie Fields
afields@lhai.com
@LHA_IR_PR
Abchurch Communications Phone: +44 207 398 7719
Adam Michael
Joanne Shears
Jamie Hooper
jamie.hooper@abchurch-group.com
Nomura Code Securities (NOMAD) Phone: +44 207 776 1200
Jonathan Senior
Giles Balleny
SVS Securities plc (Joint Broker) Phone: +44 207 638 5600
Alex Mattey
Ian Callaway
This information is provided by RNS
The company news service from the London Stock Exchange
END
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