Business Wire

ERYTECH Announces Resubmission of European Marketing Authorization Application for GRASPA in Acute Lymphoblastic Leukemia

Jaa

Regulatory News:

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced that it has resubmitted to the European Medicine Agency (EMA) its Marketing Authorization Application (MAA) for eryaspase (GRASPA®) for the treatment of patients with relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL). The MAA resubmission includes the data from ERYTECH’s GRASPALL 2009-06 Phase 2/3 clinical trial in children and adults with R/R ALL as well as additional data to address the outstanding questions of the Committee for Medicinal Products for Human Use (CHMP) of the EMA.

The GRASPALL Phase 2/3 trial, showed positive efficacy and safety results with GRASPA in combination with chemotherapy as compared to native L-asparaginase in patients with R/R ALL. The patients treated with GRASPA experienced a mean duration of L-asparaginase activity that was almost twice as long as for patients receiving native L-asparaginase. GRASPA also had a favorable safety profile in the trial and no patients who received GRASPA experienced an allergic reaction, as compared to 46% of the patients who received native L-asparaginase. Patients in the GRASPA treatment arm also had overall higher complete remission rates during induction, and GRASPA was associated with fewer drug-related adverse events.

In November 2016, ERYTECH withdrew its original MAA to allow sufficient time to provide the additional data requested in the CHMP’s Day 180 List of Outstanding Issues. ERYTECH has now resubmitted its MAA with additional data from studies on comparability, immunogenicity, and pharmacodynamic effects.

Gil Beyen, CEO and Chairman of ERYTECH, said: "Our teams have worked hard over the past weeks and months to address and compile additional data for the resubmission of the MAA for potential approval of GRASPA as a treatment for ALL. We believe these data have further strengthened our dossier for European marketing authorization. We strongly believe in the potential of our drug candidate and are looking forward to working with the EMA during the review process.”

Dr. Iman El-Hariry, Chief Medical Officer of ERYTECH, added: "We are delighted to complete the resubmission of the MAA for GRASPA in R/R ALL. Asparaginase continues to play an important role in treatment of newly diagnosed patients with R/R ALL. ERYTECH is committed to developing an effective therapy to patients with ALL and improving patient outcomes.”

About Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia (ALL) is a blood cancer affecting mainly the white blood cells. ALL is most prevalent in children between the ages of two and five, although adults are also affected. The American Cancer Society estimates that approximately 5,970 new cases of ALL will be diagnosed in the United States in 2017, resulting in approximately 1,440 deaths. Based on incidence data published in scientific literature, ERYTECH estimates that there are at least as many new cases of ALL diagnosed each year in Europe as in the United States. The risk for developing ALL declines slowly after the age of five until the mid-20s and then begins to rise again slowly after the age of 50. Although most cases of ALL occur in children, approximately 80% of deaths from ALL occur in adults. Pediatric ALL patients have a five-year survival rate of approximately 90%, while the five-year survival rate for adults drops to approximately 30% and for seniors to approximately 15%.

About ERYTECH and eryaspase (GRASPA®): www.erytech.com

Founded 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 development of products that target the amino acid metabolism of cancer, depriving them of nutrients necessary for their survival.

The company’s lead product, eryaspase, also known under the trade name GRASPA®, 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. L-asparaginase has been a standard component of multi-agent chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), but side effects limit treatment, especially in adults and patients with weak performance status. With its improved safety profile, eryaspase aims to provide L-asparaginase to patients who cannot tolerate current non-encapsulated asparaginases.

Eryaspase demonstrated positive efficacy and safety results in various studies in ALL, including in a Phase 2 study in elderly patients with ALL and a Phase 2/3 study in children and adults with relapsed or refractory ALL, as well as in pancreatic cancer, where it achieved positive results in a Phase 2b study of second-line treatment of patients with metastatic pancreatic cancer. ERYTECH believes that the positive results of its Phase 2b clinical study in second-line metastatic pancreatic cancer are significant indicators of eryaspase as a potential treatment approach in solid tumors. ERYTECH also has an ongoing Phase 1 clinical study of eryaspase in the United States in adults with newly diagnosed ALL and a Phase 2b clinical study in Europe in elderly patients with newly diagnosed acute myeloid leukemia (AML), each in combination with chemotherapy.

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

In addition to eryaspase, ERYTECH is developing two other product candidates, erymethionase and eryminase, that focus on using encapsulated enzymes to target cancer metabolism and induce tumor starvation. ERYTECH is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies (ERYMMUNE) and enzyme replacement therapies (ERYZYME).

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.

Forward-looking information

This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development plans, business and regulatory strategy, 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 ERYTECH's control. There can be no guarantees with respect to ERYTECH’s resubmission of the MAA or that its product candidates will receive the necessary regulatory approvals or that they will prove to ultimately 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 ERYTECH’s 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 this press release. 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 ERYTECH’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.

Contact information

ERYTECH
Naomi Eichenbaum
Director of Investor Relations
+33 4 78 74 44 38
+1 917 312 5151
naomi.eichenbaum@erytech.com
or
The Ruth Group
Lee Roth
Investor relations
+1 646 536 7012
lroth@theruthgroup.com
or
Kirsten Thomas
Media relations
+1 508 280 6592
kthomas@theruthgroup.com
or
NewCap
Julien Perez
Investor relations
Nicolas Merigeau
Media relations
+33 1 44 71 98 52
erytech@newcap.eu

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Edgewater Networks Announces Event Sponsorship of BroadSoft Connections 201721.10.2017 00:00Tiedote

Edgewater Networks, Inc., the industry leader in Network Edge Orchestration, announced today that it is an event sponsor of the BroadSoft Connections 2017 user conference, which takes place October 22-25 at the JW Marriott Phoenix Desert Ridge Resort & Spa in Phoenix, AZ. During the event, Edgewater Networks will feature demonstrations of the latest end-to-end network interoperability capabilities, including Zero Touch Provisioning, UC Analytics from the core to the endpoint, SD-WAN optimized for BroadSoft, and much more. Continuing a long-standing partnership with BroadSoft, Edgewater Networks has completed another level of BroadCloud certification, this time for local survivability which is critical for business continuity for SMB and Enterprise customers. BroadSoft’s PacketSmart is available on all EdgeMarc Intelligent Edges. All elements of the Network Edge Orchestration are

More than 70 Companies to Showcase Top Tech at CES Unveiled Paris20.10.2017 18:08Tiedote

The Consumer Technology Association (CTA) today announced that more than 70 exhibitors will showcase their latest innovations at the now sold-out fifth annual CES Unveiled Paris The event will focus on the Internet of Things (IoT), connectivity and smart cities, and draw more than 600 attendees. CES Unveiled Paris will run from 2-7:30 PM on Tuesday, October 24, 2017 at the Palais Brongniart. Regional technology companies, top-tier media outlets, buyers and key industry influencers will come together at CES Unveiled Paris to get a direct look at the latest industry developments. The day kicks off with a CES news conference and CTA market trends presentation. Conference programming is followed by a tabletop exhibition & networking reception. Curated exhibitors will be there to showcase top tech from robotics and audio to smart home and augmented and virtual reality. Notable

Westinghouse Receives Regulatory Approval for Analysis Methodologies20.10.2017 15:15Tiedote

Westinghouse Electric Company today announced that it has received approval from the U.S. Nuclear Regulatory Commission (NRC) for two new important analysis methodologies that will be used to upgrade Westinghouse- and Combustion Engineering-based nuclear steam supply system (NSSS) safety analyses. The approvals granted are for the new FULL SPECTRUMTM Loss of Coolant Accident (FSLOCATM) methodology and the Performance Analysis and Design Model software code update, PAD5. FSLOCA is capable of improved modeling of the transient response in a pressurized water reactor to the full spectrum of LOCA break sizes that could occur, and PAD5 is the next generation of the Westinghouse fuel rod design performance code. “These codes were developed to work in concert with each other to maximize analytical margin for nuclear utilities,” said Michele DeWitt, senior vice preside

Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®20.10.2017 15:03Tiedote

Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C. Positive results from studies of Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22. In addition, updated results f

SP3H Announces That It Has Obtained a €1.2 Million European Union Grant for Its Intelligent and Clean Vehicle (VIP) Project20.10.2017 13:47Tiedote

SP3H is proud to announce joining the very select circle of the 10 French winners of the H2020 SME Instrument Phase 2 program since 2014. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171020005325/en/ Last summer VIP received the very prestigious SME instrument phase 2 H2020 label in the "transport & smart cities mobility" category. With an overall budget of € 1.7 million, VIP is subsidized by the European Union at a rate of 70% or €1.2 million. The framework contract was officially signed early October. VIP is the pre-industrialization program for Fuelbox sensors, the world's first miniaturized scanner capable of analyzing the quality of fuels on board vehicles. The heart of the program remains closely linked to the reduction of CO2 and pollutant emissions from vehicle

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme