BARCELONA, Spain, March 15, 2012 /PRNewswire/ -- Grifols (MCE:GRF,
MCE:GRF.P and NASDAQ:GRFS), the world's third largest plasma
product manufacturer and a pioneer in the research and development
of therapeutic alternatives designed to contribute to both
scientific and social development, has acquired 51% of the equity
of Zaragoza-based company Araclon Biotech, ensuring the viability
of its projects and the future of the company.
(Logo:
http://photos.prnewswire.com/prnh/20110304/PH59473LOGO)
Araclon Biotech was created in 2004 as a spin-off from the
University of Zaragoza, and specializes in the research and
development of therapies and diagnostic methods for
neurodegenerative diseases, although it is currently focusing on
Alzheimer's disease (AD), a condition for which there is no cure
and of which there are around 350,000 to 380,000 sufferers in
Spain[1] and over 25 million in the world[2].
Grifols completed the operation by acquiring a stake in the
company through Gri-Cel S.A., an
investment vehicle created in 2010 to promote the group's
participation in fields of medicine which lie outside the scope of
its main activities, such as advanced therapies.
Following the purchase, Grifols has become Araclon Biotech's
largest shareholder, with a 51% holding, while other founding
partners retain 49% of the capital.
The addition of Grifols to the shareholders of Araclon Biotech
will guarantee the company's future and enable it to continue to
promote its R&D projects, focusing in particular on two
research lines:
- The diagnosis of AD: Using a kit patented for the
detection of amyloid beta peptides (AB) 40 and 42 in the blood.
Araclon Biotech is performing clinical studies with more than 400
individuals, the final results of which it is hoped will contribute
to the development of a tool with 3 major applications: The early
detection of AD (including in individuals with no symptoms) to
monitor patients being treated for Alzheimer's disease and to
improve the design of clinical trials on Alzheimer's disease.
- Treatments of AD: Based on immunotherapy. Research
focused on developing a series of patented vaccines which have
yielded positive results in various animal models and on which
clinical trials will start soon.
Araclon Biotech also plans in the future to pursue a number of
research initiatives in other neurodegenerative diseases related to
illnesses such as vascular dementia, fibromyalgia and multiple
sclerosis.
Araclon Biotech does not currently have any products on the
market, although its ABtest is available to the scientific
community for use in research studies.
The participation of Grifols as a leading shareholder of Araclon
Biotech will generate synergies for the group, strengthening the
development of some business lines of the Diagnostic division and
giving it a presence in the vaccine sector. It also complements
other Grifols research projects linked to the search for solutions
which promote new diagnostic and therapeutic approaches to
Alzheimer's disease including, specifically, a treatment for AD
based on plasma derivatives. As a result, the importance of this
neurodegenerative disease within the group's overall R&D
strategy has grown.
A firm commitment to the search for solutions to Alzheimer's
disease: Grifols medical trials
During recent years, Grifols has been at the forefront of some
of the most innovative research in the search for solutions for
AD.
These include the recent launch of a second medical trial for
the treatment of Alzheimer's disease with plasma derivatives. This
new approach involves combining hemapheresis treatment [3] with the
administration of albumin and intravenous immunoglobulin (IVIG),
two of the main plasma derivatives, at different intervals and in
varying doses. 300 Alzheimer's patients with mild to moderate
symptoms, divided into 3 treatment groups, plus a fourth control
group. In total, approximately 400 patients from both Spain and the United
States.
In addition, in September 2009
Grifols published preliminary results of another trial performed
with the participation of three hospitals in Spain and two in the
United States with 42 patients with Alzheimer's. These
intermediate results, which are being confirmed by the final stages
of the study, suggest a tendency to stabilize the illness in
patients receiving treatment, and for this reason Grifols decided
to extend this research by conducting a clinical trial which got
under way recently.
Araclon Biotech and Grifols: Spanish R&D in the fight
against Alzheimer's disease
The medical trials promoted by Grifols and its investment in
Araclon Biotech reflect the group's commitment to R&D,
exploring a range of complementary research which could be
translated into treatment for patients with Alzheimer's
disease.
Araclon Biotech's experience so far has been positive, both with
regard to the development of a useful, effective test which
contributes to the early diagnosis of AD, and with regard to
efforts to find a vaccine to treat the condition.
- With respect to the diagnosis of AD, Araclon is working to
develop the ABtest40 and ABtest42 kits
ABtest is based on scientific evidence which supports the
existence of a relationship between levels of amyloid beta peptides
(Pool AB) in the blood and the development of AD. ABtest 40 and
ABtest 42 are kits which enable the detection of amyloid beta
peptides AB40 and AB42 in the blood using ELISA colorimetric
techniques improved by the company. Innovations by Araclon Biotech
means that the sensitivity levels, detection rates and reproduction
capacity are greater than those of any other product on the
market.
To date, Araclon Biotech has performed 2 studies on 40 and 128
patients, with the aim of obtaining preliminary data on the
diagnostic capacity of the ABtests and their predictive efficacy in
different population groups, and is completing a third study with
255 individuals to validate the earlier results in a larger
population sample. The aim of this study is to determine the risk
of progression towards AD among patients with mild cognitive
impairment (MCI).
- Development of vaccines as treatment for AD: ABvac
Araclon Biotech has also developed and patented a treatment
based on an innovative active immunotherapy (vaccine) for amyloid
beta peptides 40 and 42. So far the group has tested formulations
of its vaccines in animal models and is awaiting approval to start
clinical trials.
In general terms, the trials performed so far have produced
promising results in terms both of efficacy and of safety. No
toxicity has been observed, and there has been a correct immune
system response, with the production of anti-AB antibodies and
evidence of active immunization.
About Alzheimer's disease
Alzheimer's disease is viewed as an epidemic of the 21st century
affecting the elderly population in the developed world. According
to the Alzheimer's Association, the disease affects 10% of
those aged over 65, and up to 25% of people aged over 85, although
only between 2% and 7% of cases are diagnosed at the early
stages.
In the United States there are
about 4.5 million patients, and it is estimated that by 2050 there
could be some 15 million. At the same time, the direct and indirect
health costs associated with caring for patients amounts to
85,000 million euros per year in
the United States alone[4].
In Spain, the situation is
similar to that of other developed countries. The prevalence of the
disease in Spain is currently
estimated at between 350,000 and 380,000 cases, according to the
team led by Dr. Jesus de Pedro of
Spain's National Epidemiology
Center. Expenditure linked to dementias, including AD, totaled
approximately 14,000 million euros
per year in 2010 (18,000 million
dollars)[1].
However, taking into account the fact that Alzheimer's disease
primarily strikes people aged 65 years or older and that the
proportion of sufferers rises with age, the phenomenon of aging
populations tends to lead to a gradual increase in the total number
of patients. Indeed, medium and long-term forecasts estimate that
in 25 years time the population with Alzheimer's disease could grow
by around 75% if current trends continue.
About Grifols and Gri-Cel
Grifols is a Spanish group, specializing in the
hospital-pharmaceutical sector, and with a presence in over 100
countries. Since 2006, Grifols ordinary (Class A) shares have been
listed on the Spanish Continuous Market and it has been included in
the Ibex-35 (GRF) since 2008. Since 2011, non-voting Grifols shares
(Class B) have also been listed on the Spanish Continuous Market
(GRF.P) and on the NASDAQ (GRFS) via ADRs (American Depositary
Receipts).
Grifols today is the world's third largest producer of plasma
derivatives by capacity and is the sector's largest European
company, with a balanced and diverse range of products. The group
will strengthen its position within the industry as a vertically
integrated company, on the basis of its completed and
additional planned investments. In terms of raw material, Grifols
is the leading plasma collection company, with supplies assured via
its network of 147 plasmapheresis centers in the United States, while its production plants
in Spain and the United States ensure that it has the
fractionation capacity to satisfy rising demand.
Geographic diversification is one of the key elements of the
group's strategy for growth, and it has a major presence in
the United States, Canada and Europe, together with a strong commitment to
R&D, to which it allocates approximate 5% of sales revenue.
Grifols holds a large number of patents and has a range of research
projects under way, of which more than a dozen have passed the
preclinical development stage.
Gri-Cel S.A. is the company
through which Grifols participates in joint R&D projects and
companies, in areas of medicine other than plasma derivatives, such
as advanced therapies. As a Grifols investment vehicle it currently
has shares on Nanotherapix (60% equity share) and Araclon Biotech
(51% equity share).
About Araclon Biotech
Founded in 2004, the company was created to develop a
large-scale research project into the diagnosis and treatment of
Alzheimer's disease. The project, which arose at the University of
Zaragoza, has been led from the start by Professor Manuel Sarasa, current Scientific Director of
Araclon Biotech.
Araclon is a company dedicated to the research and development
of therapies and methods for the diagnosis of degenerative
diseases. It currently has four projects under way: One in the
diagnosis of Alzheimer's disease (where it has already patented a
kit for the detection of blood levels of amyloid beta 40 and 42),
another for the treatment of Alzheimer's disease (based on
immunotherapy), an emerging project which seeks to address the
challenge of predicting Alzheimer's disease in asymptomatic
individuals.
Araclon holds a number of patents, including a European patent
for the treatment of Alzheimer's disease and another for its
diagnosis.
www.araclon.com – www.grifols.com
DISCLAIMER
The facts and figures contained in this report which do not
refer to historical data are "projections and forward-looking
statements". The words and expressions like "believe", "hope",
"anticipate", "predict", "expect", "intend", "should", "try to
achieve", "estimate", "future" and similar expressions, insofar as
they are related to Grifols Group, are used to identify
projections and forward-looking statements. These expressions
reflect the assumptions, hypothesis, expectations and anticipations
of the management team at the date of preparation of this report,
which are subject to a number of factors that could make the real
results differ considerably. The future results of Grifols Group
could be affected by events related to its own activity, such as
shortages of raw materials for the manufacture of its products, the
launch of competitive products or changes in the regulations of
markets in which it operates, among others. At the date of
preparation of this report Grifols Group has adopted the measures
it considers necessary to offset the possible effects of these
events. Grifols, S.A. does not assume any obligation to publicly
inform, review or update any projections and forward-looking
statements to adapt them to facts or circumstances following the
preparation of this report, except as specifically required by
law.
This document does not constitute an offer or invitation to
purchase or subscribe shares, in accordance with the provisions of
the Spanish Securities Market Law 24/1988, of July 28, the Royal Decree-Law 5/2005, of
March 11, and/or Royal Decree 1310/2005, of November 4, and its implementing
regulations.
[1] Prevalence data from the study coordinated by Dr.
Jesus de Pedro of the Centro
Nacional de EpidemiologĂa.
[2] Source: Alzheimer's Association and Alzheimer's Disease
International.
[3] Apheresis is a technique by which blood is separated out
into its different components such as plasma, red blood cells,
platelets and other cells. In this case, a quantity of plasma
similar to that obtained by plasmapheresis is collected, with the
difference that the plasma obtained is replaced with albumin. The
cells are injected straight back into the patient, enabling rapid
recovery.
[4] Data from the study "Alzheimer's & Dementia 6 (2010)
98-103" conducted by the Karolinska Institutet-Alzheimer's Disease
Research Center and i3 Innovus (Sweden)
SOURCE Grifols