ERYTECH Strengthens Its Intellectual Property Position with the Issuance of United States Patent for Erythrocytes Containing Arginine Deiminase

Regulatory News:

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris:ERYP), the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, announces the issuance of a new patent in the United States.

A United States patent entitled “Erythrocytes Containing Arginine Deiminase” has been issued by the U.S. Patent and Trademark Office (USPTO) as U.S. Patent No. 9,125,876. It covers the use of ERY-ADI, a tumor starvation product candidate arising from ERYTECH’s encapsulation platform.

The patent received 363 days of patent term adjustment (PTA), and with that PTA, has a term in the United States through at least April 2027. The term of this patent may also be eligible for limited patent term extension in the United States under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. The counterparts of this patent have already been issued in Europe, China, Japan, Canada, Korea and Australia.

ERYTECH’s patent portfolio consists of 12 patent families covering its technology platform and applications in and outside oncology and a license from the U.S. National Institutes of Health covering a diagnostic method to predict the efficacy of L-asparaginase.

About ERY-ADI

ERY-ADI, arginine deiminase encapsulated in red blood cells, is one of two new tumor starvation product candidates arising from ERYTECH’s encapsulation platform. In addition to L-asparaginase, the active ingredient in our lead product candidate ERY-ASP, we are leveraging our proprietary ERYCAPS technology to develop additional product candidates, encapsulating other therapeutic drug substances. Based on our preclinical research, we have identified two other tumor starvation enzymes, methionine-ϒ-liase (MGL) and arginine deiminase (ADI), which we believe can benefit from being encapsulated in red blood cells. MGL and ADI degrade methionine and arginine respectively, two amino acids that are essential for tumor cells to survive and grow. The resulting product candidates, ERY-MET and ERY-ADI, are currently in preclinical development. We expect to commence a Phase 1 clinical trial with ERY-MET in 2016 and a Phase 1 clinical trial with ERY-ADI as early as 2017.

About ERYTECH and ERY-ASP (GRASPA): www.erytech.com

Created in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate therapeutic drug substances inside red blood cells, ERYTECH has developed a pipeline of product candidates targeting markets with high unmet medical needs. ERYTECH’s initial focus is on the treatment of blood cancers, including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), by depriving tumors of nutrients necessary for their survival. The company has recently announced positive efficacy and safety results from its completed Phase 2/3 pivotal clinical trial in Europe with its lead product candidate, ERY-ASP, also known under the trade name GRASPA®, in children and adults with relapsed or refractory ALL. ERY-ASP consists of an enzyme, L-asparaginase, encapsulated inside donor-derived red blood cells. L-asparaginase depletes asparagine, a naturally occurring amino acid essential for the survival and proliferation of cancer cells, from circulating blood plasma. ERYTECH also has an ongoing Phase 1 clinical trial of ERY-ASP in the United States in adults with newly diagnosed ALL, and a Phase 2 clinical trial in Europe evaluating GRASPA as a first-line therapy for the treatment of elderly patients with AML, each in combination with chemotherapy. ERYTECH believes that ERY-ASP has the potential as a treatment approach in solid tumors and is conducting a Phase 2 clinical trial in Europe in patients with metastatic pancreatic cancer.

Every year over 50,000 patients in Europe and the United States are diagnosed with ALL or AML. For about 80% of these patients, mainly adults and relapsing patients, current forms of L-asparaginase cannot be used due to their toxicity or as a result of allergic reactions. ERYTECH believes that the safety and efficacy profile of ERY-ASP/GRASPA, as observed in its Phase 2/3 pivotal clinical trial, offers an attractive alternative option for the treatment of leukemia patients.

In addition to its current product candidates that focus on using encapsulated enzymes to induce tumor starvation, ERYTECH is exploring the use of its platform for developing cancer vaccines and enzyme replacement therapies.

The EMA and the U.S. Food and Drug Administration (FDA) have granted orphan drug designations to ERY-ASP/GRASPA for the treatment of ALL, AML and pancreatic cancer. ERYTECH produces ERY-ASP at its own GMP-approved and operational manufacturing site in Lyon (France), and at a site for clinical production in Philadelphia (USA). The Company has entered into licensing and distribution partnership agreements for ERY-ASP for ALL and AML in Europe with Orphan Europe (Recordati Group), and for ALL in Israel with TEVA, who will market the product under the GRASPA® brand name.

ERYTECH is listed on Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP) and is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes. ERYTECH is also listed in the US under an ADR level 1 program (OTC, ticker EYRYY).

Forward-looking information

This document may contain forward-looking statements and estimates with respect to the financial position, results of operations, business strategy, plans, objectives and 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. There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated 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. Readers are cautioned not to place undue reliance on any of these forward-looking statements. 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 law.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: http://www.businesswire.com/news/home/20150923006004/en/

Contact information

ERYTECH
Gil Beyen
Chairman & CEO
Tel: +33 4 78 74 44 38
investors@erytech.com
or
NewCap
Julien Perez / Emmanuel Huynh
Investor relations
Nicolas Merigeau
Press relations
Tel: +33 1 44 71 98 52
erytech@newcap.fr