|[December 06, 2013]
ERYTECH announces two presentations at 55th ASH annual meeting and exposition in New Orleans
LYON, France --(Business Wire)--
ERYTECH Pharma (Paris:ERYP) (Euronext Paris: FR0011471135 -
ERYP), a French biopharmaceutical company that develops
innovative treatments for acute leukemia and other oncology indications
with unmet medical needs, announces that data related to the Company's
lead product GRASPA® will be the subject of two poster
presentations at the 55th American Society of Hematology (ASH) Annual
Meeting and Exhibition on December 7 and 8 in New Orleans, USA.
"L-Asparaginase Sensitivity and Asparagine Synthetase Expression In
Primary Tumor Cells From AML Patients" will be presented on Saturday,
December 7th at 5:30 pm. This presentation underlines the
scientific and medical rationale to use L-asparaginase in this
indication. The design of the ongoing Phase IIb study with ERYTECH's
lead product, GRASPA®, in Acute Myeloid Leukemia will be also explained.
A safety review by an external data safety monitoring board (DSMB)
recently confirmed the safety profile of the product in this very
fragile patient population.
"L-Asparaginase Loaded Inside Red Cells Has An Acceptable Tolerability
Profile On Bilirubin Value" will be presented on Sunday, December 8th
at 6:30 pm, focusing on the liver tolerability and safety assessments
performed on the available data with the lead product GRASPA® in Acute
Lymphoblastic Leukemia in ERYTECH's completed clinical trials. The
presentation will be made in collaboration with Orphan Europe (Recordati
Group), ERYTECH's co-development and licensing partner in Europe.
"These two poster presentations at ASH annual meeting support the
potential of our lead product, GRASPA®, to treat very fragile patients
with an asparaginase-based product. The use of asparaginase has to date
been very limited in these patients due to the toxicity of the current
forms." said Dr Yann Godfrin, CSO at ERYTECH.
About ERYTECH and GRASPA®: 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. Every year about 50,000 patients are diagnosed with
Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML), the
two forms of acute leukemia. Today, for about 80% of these patients,
mainly adults and relapsing patients, there is no adequate solution due
to the toxicity of existing treatments, representing a market
opportunity of more than EUR 1 billion. By encapsulating the
asparaginase enzyme in red blood cells, ERYTECH has developed GRASPA®,
an original and effective treatment that targets leukemia cells through
"starvation" while significantly reducing the side effects for patients,
and allowing all patients to be treated, even the most fragile ones.
GRASPA® is currently completing Phase III clinical development in Acute
Lymphoblastic Leukemia (ALL) and is in Phase IIb clinical trial in Acute
Myeloid Leukemia (AML). ERYTECH has concluded distribution partnership
agreements for Europe with Orphan Europe (Recordati Group), and with
TEVA for Israel. In the United States, ERYTECH is launching a Phase Ib
clinical trial in ALL, after having received approval from the US FDA.
GRASPA® benefits from the orphan drug status both in ALL and in AML.
The company is also developing other indications in solid tumors and
certain orphan indications outside oncology. ERYTECH has its own
GMP-approved and operational manufacturing site.
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.
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.
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