ERYTECH Announces Withdrawal Of Its European Marketing Authorization Application For GRASPA For Acute Lymphoblastic Leukemia And Prepares For Resubmission

Regulatory News:

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP), the French biopharmaceutical company developing 'tumor starvation' treatments for acute leukemia and other oncology indications with unmet medical needs, today announced its decision to withdraw the current MAA for GRASPA for the treatment of acute lymphoblastic leukemia (ALL). The Company determined that the time allowed in the CHMP procedure was not sufficient to provide the additional data requested in the CHMP's Day 180 List of Outstanding Issues (LOI). The Company intends to resubmit an MAA around mid-2017.

Following positive efficacy and safety results from the completed European Phase 2/3 pivotal study in patients with relapsed and refractory ALL, ERYTECH submitted an MAA for GRASPA in September 2015. The Company received the Day 180 LOI in September 2016 and has been in discussion with the Rapporteur/Co-rapporteur and the CHMP to provide the requested additional data regarding the comparability between the old and new form of asparaginase encapsulated in GRASPA and the development of a new immunogenicity assay, as well as the pharmacodynamics effects of eryaspase. Given the fact that the generation of these additional data will require more time than allowed in the CHMP's approval procedures, the Company has notified the CHMP of the withdrawal of the application at this time. The Company intends to resubmit the MAA mid-2017, as soon as the newly generated data are available.

"It is disappointing that assembling the data necessary to properly address the remaining questions is requiring longer time than we were actually granted at this stage. Our pivotal trial demonstrated improved clinical outcome and an excellent safety profile with eryaspase compared to native asparaginase. We are committed to pursuing regulatory approval for GRASPA and intend to work closely with our investigators and advisors to generate the additional information requested and to resubmit an MAA next year" said Iman El-Hariry, Chief Medical Officer of ERYTECH.

"The decision to withdraw at this stage was not an easy one, but does not change our commitment to bringing eryaspase to the market." comments Gil Beyen, ERYTECH's Chairman and Chief Executive Officer. "We believe we have generated strong clinical data in our different programs of eryaspase, and we continue to execute our plans towards making the product available to patients with aggressive forms of cancer, such as acute lymphoblastic leukemia, acute myeloid leukemia and pancreatic cancer. We are not aware of any safety issues and our other clinical trials are not affected. We will continue to pursue our planned clinical strategy in ALL and AML in close collaboration with our European partner Orphan Europe (Recordati Group)".

Conference Call Details

ERYTECH management will hold a conference call and webcast on Tuesday, November 15, 2016 at 15:00 pm CET / 9:00am ET to discuss the withdrawal decision and plan forward. Gil Beyen, Chairman and CEO, Eric Soyer, CFO and COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.