Regulatory Filings • Nov 7, 2014
Regulatory Filings
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Lyon, France, November 7, 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 need, announces the presentation of four case studies with GRASPA® in an expanded access program at the 56th Annual Meeting of the American Society of Hematology (ASH), December 6-9, 2014, in San Francisco, CA.
The expanded access program (#NCT02197650) was set up to provide access to GRASPA® to patients with acute lymphoblastic leukemia (ALL), in first line or relapse, who are at severe risk to receive any other asparaginase formulations because of prior hypersensitivity reactions to both the E. Coli and Erwinia derived asparaginases.
The first results of this program indicate a strongly reduced risk of hypersensitivity reactions in these 'double allergic' patients while maintaining adequate asparaginase activity and they bring an additional confirmation of GRASPA®'s reduced immunotoxicity, also in patients with prior allergies to E. Coli derived asparaginase, as was recently demonstrated in the top-line results of its Phase III study in relapsing ALL.
The abstract #937 entitled "L-Asparaginase Allergic Patients Treated with L-Asparaginase Loaded into Red Blood Cells in an Expanded Access Program. Report of Four Cases" will be presented by Prof. Yves Bertrand, Head of the Institute of Pediatric Hemato-Oncology, Lyon, France, as a poster presentation.
Session: 612. Acute Lymphoblastic Leukemia: Clinical Studies: Poster I Date: Saturday, December 6, 2014 Time: 5:30 PM - 7:30 PM
The abstract is now available on the ASH website at www.hematology.org
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®, an original and effective treatment that destroys cancerous cells through "starvation" while significantly reducing side effects. ERY-ASP/GRASPA® has recently announced positive top-line Phase III data in Acute Lymphoblastic Leukemia (ALL) and is in Phase IIb in Acute Myeloid Leukemia (AML) in Europe. The product is also in Phase I/II in ALL in the U.S.
Every year about 50,000 patients are diagnosed with ALL or AML in Europe and the U.S. Today, about 80% of these patients, mainly relapsing adults and children, cannot use the current forms of asparaginase due to their toxicity. ERY-ASP is being developed with the goal of improving the tolerability profile in order to treat all patients diagnosed with acute leukemia, even the most fragile ones. The market segment addressed by ERYTECH represents a potential of 1 billion euros.
The Company is also developing treatments for solid tumors and some orphan indications outside oncology. It is currently conducting a Phase II study on pancreatic cancer in Europe and examining other solid tumor indications for ERY-ASP.
The Company has obtained orphan drug designations for ERY-ASP/GRASPA® in ALL, AML and pancreatic cancer in Europe and the U.S. It has its own operational manufacturing sites in Lyon, France and Philadelphia in the U.S.
ERYTECH has concluded two distribution partnership agreements, one in Europe with Orphan Europe (Recordati Group), one of the main actors in orphan drugs, and the other in Israel with the TEVA Group.
ERYTECH is listed on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker code: ERYP) and is part of the CAC All Shares, CAC Healthcare, CAC Pharma & Bio, CAC Small, CAC Mid&Small, CAC All Tradable and Next Biotech indexes. ERYTECH shares are eligible to PEA-PME (French share savings plan for SMEs).
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.
Gil Beyen Chairman and Chief Executive Officer Pierre-Olivier Goineau Vice President, Chief Operating Officer Tel.: +33 4 78 74 44 38 [email protected]
Julien Perez & Emmanuel Huynh Investor Relations Nicolas Mérigeau Press Contact Tel.: +33 1 44 71 98 52 [email protected]
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