Medgenics Signs Development Agreement with Major International Pharma Company
October 23 2009 - 4:57AM
Business Wire
Medgenics (AIM:MEDG)(AIM:MEDU) is pleased to announce that it
has signed a preclinical development and option agreement with a
major international biopharmaceutical company that is a market
leader in the field of hemophilia. This groundbreaking feasibility
agreement is worth up to $7 million in payments that will include
funding for preclinical development of Medgenics’ Biopump protein
technology to produce and deliver clotting protein Factor VIII for
the sustained treatment of hemophilia.
Under the terms of the agreement, Medgenics will receive $4
million to work exclusively with this partner for one year to
develop a Biopump to test the feasibility of continuous production
and delivery of this clotting protein. Additional payments totaling
$3 million are payable upon Medgenics meeting certain technical
milestones and upon the partner’s exercise of an option to extend
the exclusivity through an additional period to negotiate terms to
commercialize the Biopump technology for Factor VIII. This is a new
application of the Biopump tissue protein therapeutic platform,
which has previously demonstrated success in the production of
erythropoietin (“EPO”) in treating renal anemia and interferon
alpha for use in treating hepatitis-C. The market for Factor VIII
is greater than $3.2 billion per year (La Marie 2008), and
according to the World Federation of Hemophilia, some 400,000
people in the world have hemophilia.
Dr. Andrew Pearlman, Chief Executive Officer of Medgenics,
said:
"We are very excited to have reached this key milestone toward
commercialization of our technology. The fact that this agreement
is for a new therapeutic application of our Biopump demonstrates
the versatility of our platform technology. It further validates
the belief that our platform can be applied to help treat many
chronic diseases and will attract further interest from other major
partners. The fact that a market leader in hemophilia has entered
such an agreement at this early stage testifies to the promise of
the Biopump technology for use in treating hemophilia. It reflects
our mutual expectation that this feasibility program will be
successful and will lead to a definitive agreement to complete the
development and to commercialize this unique and exciting new
therapeutic option which could make a major difference in the lives
of hemophilic patients.”
“Medgenics' Biopump platform technology has already achieved
unprecedented results in the sustained treatment of anemia; the
only indication that we have tested in patients to date. In a Phase
I/II clinical study using our EPODURE Biopumps to produce and
deliver EPO in patients with chronic kidney disease, a single
administration of EPODURE Biopumps has been shown to provide
effective anemia treatment for up to 12 months without any need for
additional EPO injections. We believe our Biopump technology will
address many of the current challenges in healthcare and provide an
important advance for the treatment of chronic disease.”
“While this first agreement is directed to the treatment of
hemophilia, Medgenics is continuing its discussions with other
potential partners with a view to signing additional agreements for
other indications using different therapeutic proteins.”
About Medgenics:
Medgenics is a clinical-stage biopharmaceutical company
developing its unique tissue-based Biopump platform technology to
provide sustained-action protein therapy for the treatment of a
range of chronic diseases. The Company currently has three products
in development based on this technology and addressing the
indications of:
- Anemia – using EPODURE, a Biopump producing erythropoietin
(EPO)
- Hepatitis-C - using INFRADURE – a Biopump producing
interferon-alpha (IFN-a)
- Hemophilia - using a Biopump to produce clotting Factor
VIII
The Company's Phase I/II clinical trial using EPODURE to treat
anemia in patients with chronic kidney disease, has demonstrated
proof of concept of the Biopump. Designed to produce and deliver a
therapeutic dose of EPO steadily for six months or more, EPODURE
Biopumps have already provided effective anemia treatment in most
of these patients for 6-12 months, even at the low administered
dose.
Medgenics intends to develop its innovative products and bring
them to market via multiple strategic partnerships with major
pharmaceutical and/or medical device companies. In addition to
treatments for Anemia, Hepatitis-C, 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 US $87 billion by 2010. Other
potential applications of Biopumps producing various proteins
include multiple sclerosis, arthritis, pediatric growth hormone
deficiency, obesity, and diabetes.
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