TIDMMEDG TIDMMEDU
RNS Number : 8555B
Medgenics Inc
23 April 2012
Medgenics Files for U.S. Orphan Drug Designation for INFRADURE
for the Treatment of Hepatitis D
Designation could open pathway to expedited approval of platform
protein delivery technology and additional market exclusivity
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the
developer of a novel technology for the sustained production and
delivery of therapeutic proteins in patients using their own
tissue, today announced that it has filed for Orphan Drug
Designation with the U.S. Food and Drug Administration (FDA) for
INFRADURE(TM) for the treatment of hepatitis D. INFRADURE is based
on Medgenics' proprietary tissue-based Biopump(TM) platform
technology, which uses the patient's own tissue to continuously
produce and deliver therapeutic proteins, such as interferon-alpha
for use in the treatment of hepatitis.
Orphan Drug Designation carries multiple benefits, including the
availability of grant money, certain tax credits and seven years of
market exclusivity, as well as the possibility of an expedited
regulatory process.
This application for Orphan Drug Designation follows Medgenics'
recent submission of an Investigational New Drug (IND) application
to the FDA for a Phase IIb anemia trial in dialysis patients using
EPODURE(TM), a different implementation of the same Biopump
platform that produces erythropoietin (EPO).
Marlene Haffner, M.D. MPH, former Director of Orphan Products
Development at the FDA, and regulatory advisor to Medgenics said,
"INFRADURE's application for the treatment of hepatitis D appears
to meet the key criteria required for Orphan Drug Designation by
the FDA, as the number of U.S. patients with this disease is
estimated to be considerably fewer than 200,000. Furthermore,
preclinical data support that INFRADURE has a reasonable rationale
for treatment of the disease based on its potential ability to
continuously delivery interferon alpha, the current standard of
care for hepatitis D that is administered by years of repeat
injections. Should Orphan Drug Designation be granted, the
regulatory approval route for INFRADURE for the treatment of
hepatitis D could be significantly expedited."
This Orphan Drug Designation filing marks the first application
for Medgenics' Biopump technology seeking an expedited regulatory
pathway in the U.S. Obtaining Orphan Drug Designation could
potentially allow for substantially smaller pivotal clinical
trials, as compared to a more wide-spread disease. This could lead
to more immediate access of the treatment to a patient population
in need. Medgenics expects to receive the FDA's initial response to
the filing before the end of this quarter, and believes Orphan
Designation could be confirmed during the third quarter.
Bruce Bacon, M.D., past President of the American Association
for the Study of Liver Disease and a recognized global expert in
hepatitis who serves on Medgenics' Strategic Advisory Board,
commented, "The current treatment for hepatitis D requires years of
weekly injections of interferon alpha, which leads to patient
discomfort and substantial compliance challenges. Oral antiviral
treatments have proven to be ineffective. INFRADURE is intended to
be implanted infrequently, with a single administration potentially
replacing many months of weekly injections. This could offer a safe
and efficacious treatment that could greatly improve patient
compliance. Medgenics' treatment is potentially a game changer not
only as a treatment for hepatitis D, but also as a key element in
the treatment of various other forms of hepatitis worldwide."
"Our application for Orphan Drug Designation for hepatitis D
demonstrates Medgenics' commitment to the treatment of hepatitis.
Obtaining Orphan Drug Designation could be the most rapid route for
us to bring our Biopump technology to the U.S.," stated Andrew L.
Pearlman, Ph.D., President and Chief Executive Officer of
Medgenics. "We recently submitted an IND application with the FDA
for a Phase IIb anemia trial for EPODURE, a version of the Biopump
which produces a different protein, EPO, and have received approval
in Israel to commence a Phase IIa trial for that same indication.
We are very encouraged with the momentum we are building in 2012 as
these important clinical advancements reflect the progress that
various applications of our platform technology are making through
regulatory approval processes as we continue to build shareholder
value."
"We are eager to pursue this niche opportunity in hepatitis D,
which would use a similar INFRADURE approach to that we will employ
in treating hepatitis C in a Phase I/II study in Israel that is
scheduled to commence in the third quarter of 2012 pending final
regulatory approval. Receiving Orphan Drug Designation for our
INFRADURE Biopump in the treatment of hepatitis D could lead not
only to an expedited approval route based on clinical studies of
moderate size for this specific rare indication, but could also
represent a significant advancement of our entire portfolio of
treatments. Such an approval may serve to pave the way for a more
rapid pace at which our platform protein delivery technology can
move through the FDA approval process for other multibillion-dollar
clinical indications," added Dr. Pearlman.
About Hepatitis D
According to the U.S. Centers for Disease Control and
Prevention, hepatitis D, also known as "delta hepatitis," is a
serious liver disease caused by infection with the hepatitis D
virus (HDV), which is an RNA virus structurally unrelated to the
hepatitis A, B or C viruses. Hepatitis D, which can be acute or
chronic, is not common in the United States. HDV is an incomplete
virus that requires the helper function of the hepatitis B virus
(HBV) to replicate and only occurs among people who are infected
with HBV. HDV is transmitted through percutaneous or mucosal
contact with infectious blood and can be acquired either as a
co-infection with HBV or as a super-infection in persons with HBV
infection. There is no vaccine for hepatitis D, but it can be
prevented in persons who are not already HBV-infected by
administrative of the hepatitis B vaccination. Hepatitis D infects
about 15 million people worldwide.
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 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 is
about to commence a Phase IIa safety/efficacy trial in dialysis
patients in Q2 2012 in Israel. An IND has been filed with the U.S.
Food and Drug Administration 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 Q3 2012.
-- 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
Religare Capital Markets (UK) Limited Phone: +44 207 444 0542
(NOMAD)
David Porter
Richard Thompson
SVS Securities plc (Joint Broker) Phone: +44 207 638 5600
Alex Mattey
Ian Callaway
Nomura Code Securities (Joint Broker) Phone: +44 207 776 1219
Jonathan Senior
- Ends -
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The company news service from the London Stock Exchange
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