LYON, France--(BUSINESS WIRE)--Regulatory News :
ERYTECH (Paris:ERYP) (NYSE Euronext Paris: FR0011471135 - ERYP), a French biopharmaceutical company that develops innovative treatments for acute leukemia and other oncology indications with unmet medical needs, announces it received notification of allowance for the granting of its core process patent in the United States with two additional years of exclusivity in the United States.
This patent entitled “Lysis/Resealing Process and Device for Incorporating an Active Ingredient, in particular Asparaginase or Inositol Hexaphosphate, in Erythrocytes“ describes and claims the process and methods for preparing erythrocytes which reproducibly contain a well-defined amount of active ingredient for use as a pharmaceutical product. This patent is the core protection of the technology platform and products developed by ERYTECH, including the GRASPA® product used in Phase III clinical trials in Acute Lymphoblastic Leukemia which recruitment was just achieved and Phase IIb in Acute Myeloid Leukemia.
The patent application was filed in 2004 and had in the mean time been granted in Europe, Australia, China, Hong-Kong and Japan. Yann Godfrin, scientific founder of ERYTECH, is the sole inventor and ERYTECH is the sole owner of the title. No license fees are due to any third party.
Under the US law and the determination of Patent Term Adjustment, the term of this patent has currently been extended for approximately 2 additional years, which means protection until mid 2027 in the United States. This term can possibly be further extended to 2032 on the basis of the patent term extension that may be available based on future marketing authorization.
The patent portfolio of ERYTECH consists today of 12 patent families worldwide, covering its technology platform, its products as well as their therapeutic uses.
“Building a strong position in the USA is an important element of our value creation strategy. In collaboration with the American Red Cross we have a fully validated pilot scale manufacturing facility in Philadelphia. We are preparing the launch of our first clinical trial in the USA, and are now further building our foothold in this important healthcare market. The granting of our patent is another important pillar in doing so”, said Pierre-Olivier Goineau, co-founder and COO of ERYTECH.
About ERYTECH: 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. 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 NYSE 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.