DGAP-News

ERYTECH announces granting of new patent in the United States

DGAP-News: ERYTECH PHARMA SA / Key word(s): Patent
ERYTECH announces granting of new patent in the United States

21.10.2014 / 10:00

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ERYTECH reports positive top-line Phase III results from clinical study
with GRASPA(R)in Acute Lymphoblastic Leukemia

- GRASPA(R) meets primary endpoints compared to native L-asparaginase:

- Statistically significant reduction of allergic reactions

- Statistically significant increase in duration of asparaginase
activity

- Secondary endpoints confirm the favorable clinical efficacy of
GRASPA(R)

- GRASPA(R) well tolerated by patients with previous allergies to
L-asparaginase

- Submission of European marketing authorization application targeted for
1H 2015

- Important validation of ERYTECH's technology forming strong basis for
further leveraging the product and platform in other oncology
indications



Lyon (France), September 30, 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 needs, reports positive Phase III results from its
pivotal study with GRASPA(R) in Acute Lymphoblastic Leukemia.

Analysis of the primary and first secondary efficacy endpoints of the
GRASPALL clinical trial with one year follow up shows that the GRASPIVOTALL
(GRASPALL2009-06) clinical trial convincingly meets both of its primary
endpoints, and that the secondary efficacy endpoints analyzed so far
confirm the favorable clinical efficacy profile of GRASPA(R). The study
also shows favorable results in patients with prior allergies to
L-asparaginase.

The GRASPIVOTALL study is a controlled, multicenter Phase II/III trial with
80 children and adults suffering from relapsing or refractory Acute
Lymphoblastic Leukemia (ALL) with three arms. The first two arms compare
GRASPA(R) to native E. Coli L-asparaginase, both in combination with
standard chemotherapy (COOPRALL), in a 1-to-1 randomization in patients
without prior allergies to L-asparaginase. The third arm is an open label
assessment of GRASPA(R) for patients who have experienced allergic
reactions related to asparaginase in their first line treatment.

The primary endpoint of the study consisted of two objectives, in
accordance with CHMP advice: a) superior safety, expressed as a
significant reduction of the incidence of allergic reactions with GRASPA(R)
compared to the control group, and b) non-inferior duration of asparaginase
activity above the threshold of 100 IU/l during the induction phase in the