DGAP-News: ERYTECH PHARMA SA / Key word(s): Patent
ERYTECH PHARMA SA: ERYTECH announces granting of new patent in the
United States
21.10.2014 / 11:24
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ERYTECH announces granting of new patent in the United States
- Patent that can strengthen positioning of ERY-ASP/GRASPA(R) by
detecting the presence of neutralizing antibodies to asparaginase
- Patent delivered in the USA with patent term until 2029
- Patent already granted in Europe, Australia and Singapore
Lyon (France), October 21, 2014 - ERYTECH (Euronext Paris: FR0011471135 -
ERYP), the French biopharmaceutical company that develops innovative 'tumor
starvation' treatments for acute leukemia and other oncology indications
with unmet medical needs, announces the granting of a new patent in the
field of asparaginase in the United States.
The patent 'Test for predicting neutralization of asparaginase activity'
(WO 2010/052315 A1) protects the process and methods for the detection of
factors neutralizing the activity of asparaginase in patients, notably
anti-asparaginase antibodies. A large percentage of patients treated with
current forms of asparaginases are known to develop neutralizing antibodies
to asparaginase, which drastically reduces its activity and treatment
efficacy. In addition, these patients have a higher chance to develop
hypersensitivity reactions, some of which can be severe. Detecting the
presence of these neutralizing factors before the administration of
asparaginase can reduce the risk of treatment inefficacy and allergic
reactions by enabling to propose the product with the best risk profile in
these conditions.
In the clinical studies with ERY-ASP/GRASPA(R), a very significant
reduction of allergic reactions and a sustained asparaginase activity have
been observed, even in the presence of antibodies, and this thanks to the
encapsulation of the asparaginase in red blood cells. Recent analysis of
the top-line Phase III results of the GRASPIVOTALL (GRASPALL2009-06) study
in relapsing Acute Lymphoblastic Leukemia (ALL) has shown favorable
results, also in patients who had prior allergies to L-asparaginase. In
patients without history of allergic reactions, none of the patients
developed allergies to GRASPA(R) versus 43% for the native
L-asparaginase. Only two of twenty-six patients with prior allergies to
L-asparaginase developed allergies to GRASPA(R) and these have been of mild
nature. In these patients the average duration of asparaginase activity
observed was similar to the duration observed in non-allergic patients
(18.6 days of asparaginase activity above 100IU/l versus 20.3 days in the
non-allergic patients). These results seem to confirm the hypothesis that
the encapsulated asparaginase is not 'visible' to the circulating
antibodies, which allows it to continue its activity without the formation
of immunogenic complexes.
The interest for ERYTECH would be to make available a test to clinicians
allowing to detect neutralizing antibodies earlier and to switch to other
forms of asparaginase, like ERY-ASP/GRASPA(R), faster and before clinical
symptoms of allergies or inactivation occur.
The patent application was filed in 2009. The patent has in the meantime
been granted in Europe, Australia and Singapore, and now also in the United
States. According to American law, the patent will be valid until mid 2029.
ERYTECH's patent portfolio consists of 13 patent families worldwide,
covering its technologies, its products and their therapeutic usages.
« The granting of this new patent in the United States is an additional
tool to favor the future adoption of ERY-ASP/GRASPA(R) by physicians. The
test based on this patented technology will be developed in collaboration
with a specialized industrial partner in view of making it available at the
time of European Marketing Authorization, aimed by mid 2016 », comments
Pierre-Olivier Goineau, co-founder and COO of ERYTECH Pharma.
About ERYTECH and ERY-ASP/GRASPA(R): www.erytech.com
Created in Lyon in 2004, ERYTECH is a French biopharmaceutical company
providing new prospects for cancer patients, particularly those with acute
leukemia and selected solid tumors.
By encapsulating the asparaginase enzyme in red blood cells, ERYTECH has
developed ERY-ASP/GRASPA(R), an original treatment that targets cancer
cells through "tumor starvation" while significantly reducing the side
effects for patients. ERY-ASP/GRASPA(R) is currently completing Phase III
clinical development in Acute Lymphoblastic Leukemia (ALL) and is in Phase
IIb clinical trial in Acute Myeloid Leukemia (AML) in Europe. The product
is also in Phase I/II clinical development in ALL in the USA.
Every year about 50,000 patients are diagnosed with ALL or AML, the two
forms of acute leukemia. Today, for about 80% of these patients, mainly
adults and relapsing patients, current forms of asparaginase cannot be used
due to their toxicity. With a presumed improved safety profile,
ERY-ASP/GRASPA(R) is being developed to allow all leukemia patients to be
treated, even the most fragile ones, representing a market opportunity of
more than EUR 1 billion.
The company is also developing other indications in solid tumors and
certain orphan indications outside oncology. The company is currently
launching a Phase II study in pancreas cancer and is exploring other solid
tumor indications.
ERYTECH has obtained orphan drug designations for ERY-ASP/GRASPA(R) in ALL,
AML and pancreas cancer, both in Europe and the USA, and has its own
GMP-approved and operational manufacturing site in Lyon (France), and a
site for clinical production in Philadelphia (USA).
The company has concluded licensing and distribution partnership agreements
for ALL and AML in Europe with Orphan Europe (Recordati Group), and for ALL
with TEVA in Israel.
ERYTECH is listed on Euronext regulated market in Paris. (ISIN code:
FR0011471135, ticker: ERYP) and is part of the CAC Healthcare, CAC Pharm. &
Bio and Next Biotech indexes.
Forward-looking information
This document may contain forward-looking statements and estimates with
respect to the financial situation, the results of operations, the
strategy, the project and to the anticipated future performance of ERYTECH
and of the market in which it operates. Certain of these statements,
forecasts and estimates can be recognized by the use of words such as,
without limitation, "believes", "anticipates", "expects", "intends",
"plans", "seeks", "estimates", "may", "will" and "continue" and similar
expressions. They include all matters that are not historical facts. Such
statements, forecasts and estimates are based on various assumptions and
assessments of known and unknown risks, uncertainties and other factors,
which were deemed reasonable when made but may or may not prove to be
correct. Actual events are difficult to predict and may depend upon factors
that are beyond the Company's control. Therefore, actual results, the
financial condition, performance or achievements of ERYTECH, or industry
results, may turn out to be materially different from any future results,
performance or achievements expressed or implied by such statements,
forecasts and estimates. Documents filed by ERYTECH Pharma with the French
Autorité des Marchés Financiers (www.amf-france.org), also available on our
website (www.erytech.com) describe such risks and uncertainties. Given
these uncertainties, no representations are made as to the accuracy or
fairness of such forward-looking statements, forecasts and estimates.
Furthermore, forward-looking statements, forecasts and estimates only speak
as of the date of the publication of this document. ERYTECH disclaims any
obligation to update any such forward-looking statement, forecast or
estimates to reflect any change in the Company's expectations with regard
thereto, or any change in events, conditions or circumstances on which any
such statement, forecast or estimate is based, except to the extent
required by French law.
CONTACTS
<pre>
ERYTECH NewCap
Gil Beyen Julien Perez & Emmanuel Huynh
Chairman & CEO Investor Relations
Pierre-Olivier Goineau Nicolas Mérigeau
Vice-President & COO Press Relations
Tel : +33 4 78 74 44 38 Tel : +33 1 44 71 98 52
investors@erytech.com erytech@newcap.fr
</pre>
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DGAP-News: ERYTECH PHARMA SA: ERYTECH announces granting of new patent in the United States
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