MILANO, ITALY--(Marketwire - Nov 23, 2012) - Recordati announces that its subsidiary
Orphan Europe
and Erytech Pharma, a late development stage French biopharmaceutical
company
focused on orphan oncology and rare diseases, have entered into an
agreement
granting Orphan Europe the exclusive rights for the
commercialization and
distribution of Graspa® for the treatment of Acute Lymphoblastic
Leukemia (ALL)
and Acute Myeloid Leukemia (AML) in Europe. Graspa®, human
erythrocytes
encapsulating L-asparaginase, for the treatment of hematological
malignancies,
is currently in pivotal Phase II/III clinical trial for ALL and will
enter a
Phase IIb trial in AML in Europe. The product has obtained an orphan
drug
designation in Europe and the USA for ALL.
Graspa® is a new formulation of L-asparaginase with a safer and broader
range of
clinical use than existing forms due to the entrapment and protection
of the
enzyme inside homologous red blood cells. The added value of
Graspa® (by
encapsulating L-asparaginase in red blood cells) relates to its
ability to
overcome existing limitations associated with conventional L-
asparaginase via
longer efficacy, better compliance, reduced doses and a better safety
profile.
Graspa® is intended to satisfy the unmet medical needs of frail
patients,
patients suffering relapses and other patient groups for whom the
current
treatments are not suitable.
Marco Liguori CEO of Orphan Europe is delighted with this new partnership
"The
Orphan Europe team has considerable experience in the orphan drug field
and the
special requirements of rare diseases. We are committed and prepared to
ensure
that these treatments become available for patients in Europe rapidly".
"We are very pleased to announce this agreement with Orphan Europe
(Recordati
Group)" said Pierre-Olivier Goineau, Chief Executive Officer of
Erytech. "We
believe we have found a partner that is uniquely positioned to ensure
market
access and commercial success of our lead product in ALL, and to
advance the
product in AML. Erytech will manufacture the product. This agreement is a
major
milestone for Erytech, and a clear recognition of the potential
of our
technology. It will allow us to focus on our developments in the US in
solid
tumors and in other rare disease indications".
About Orphan Europe
Orphan Europe was founded in 1990 and acquired by Recordati in 2007.
For the
past two decades Orphan Europe has developed and marketed orphan
drugs for
patients with rare diseases. In 2000 orphan drugs were defined by the
European
Drug Regulation as a treatment for a life-threatening or
chronically
debilitating condition affecting no more than five in 10,000
persons. The
parameters involved in the development of an orphan drug are very different
from
the development of conventional drugs, for example there is a limited
number of
patients and a scarcity of expertise. Therefore Orphan Europe's
approach is
based on combined efforts between the company, patients and the
medical
community with the overall aim to improve the life of affected persons.
Orphan Europe has also built the Orphan Europe Academy with the aim to
further
the understanding of rare diseases and provide a forum for sharing
knowledge and
developing new ideas.
About Erytech
Erytech Pharma SA is a late-stage French biopharmaceutical company
developing
medicinal products for orphan oncology and rare diseases. The
company's
proprietary core technology is based on the use of human red blood cells
(RBCs)
to improve the pharmacokinetic (PK) and pharmacodynamic (PD)
properties of
therapeutic molecules.
Erytech has established a cGMP approved manufacturing facility that can
meet the
demand for Graspa® products in Europe.
The company is expanding the use of its technology in oncology to Acute
Myeloid
Leukemia and solid tumors, and outside oncology in enzyme replacement
therapy,
immunology and haematology indications.
Recordati, established in 1926, is a European pharmaceutical group,
listed on
the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM,
ISIN IT
0003828271), with a total staff of over 3,200, dedicated to the
research,
development, manufacturing and marketing of pharmaceuticals.
Headquartered in
Milan, Italy, Recordati has operations in the main European
countries, in
Central and Eastern Europe, and in Turkey. A field force of around
1,700
medical representatives promotes a wide range of innovative
pharmaceuticals,
both proprietary and under license, in a number of therapeutic areas
including a
specialized business dedicated to treatments for rare diseases. Recordati
is a
partner of choice for new product licenses from companies which do not
have a
European presence. Recordati is committed to the research and
development of
new drug entities within the cardiovascular and urogenital therapeutic
areas and
of treatments for rare diseases. Consolidated revenue for 2011 was EUR
762.0
million, operating income was EUR 163.5 million and net income was
EUR 116.4
million.
Statements contained in this release, other than historical facts, are
"forward-
looking statements" (as such term is defined in the Private Securities
Litigation Reform Act of 1995). These statements are based on currently
available information, on current best estimates, and on assumptions
believed to
be reasonable. This information, these estimates and assumptions may prove
to be
incomplete or erroneous, and involve numerous risks and uncertainties,
beyond
the Company's control. Hence, actual results may differ materially from
those
expressed or implied by such forward-looking statements. All mentions and
descriptions of Recordati products are intended solely as information on
the
general nature of the company's activities and are not intended to indicate
the
advisability of administering any product in any particular instance
RECORDATI LICENSES GRASPA® FROM ERYTECH IN EUROPE:
http://hugin.info/143644/R/1660193/537599.pdf
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: RECORDATI via Thomson Reuters ONE
[HUG#1660193]