ERYTECH Provides Regulatory Update
ERYTECH Provides
Regulatory Update
- ERYTECH
to stop further plans to pursue a BLA submission seeking
an approval for
Graspa® in hypersensitive
ALL
- Evaluation of strategic
partnering options
ongoing
Cambridge, MA (U.S.)
and Lyon (France),
August
24,
2022 –
ERYTECH Pharma (Nasdaq & Euronext:
ERYP), a clinical-stage
biopharmaceutical company developing innovative therapies by
encapsulating therapeutic drug substances inside red blood cells,
today provided a regulatory update,
announcing that it is no longer
seeking approval for
Graspa® in
hypersensitive acute lymphoblastic leukemia
(ALL) following
feedback from the U.S. Food and Drug
Administration (FDA).
“We are obviously disappointed to stop the
process of seeking approval for Graspa in ALL after all the work
done and clinical promise observed in this indication,”
said Gil Beyen,
Chief
Executive
Officer of
ERYTECH. “In multiple clinical trials, Graspa showed
promising results for patients, and we were encouraged by the
dialogue with the FDA and the Fast Track designation that we
received for this indication last year. However, the changing
competitive landscape, combined with new FDA’s requests for
additional clinical data that would require significant additional
resources on our part, led to the difficult decision to stop the
development of Graspa in ALL. We are now focusing our resources on
our most promising preclinical programs, while pursuing strategic
partnering options to maximize value for our shareholders and
employees.”
Following positive results of a Phase 2 trial,
sponsored by the Nordic Organization for Paediatric Haematology and
Oncology (NOPHO), presented at the 2020 American Society of
Hematology annual meeting, ERYTECH has been in discussions with the
FDA for the approval of Graspa to treat ALL patients who had
previously experienced hypersensitivity reactions to pegylated
asparaginase therapy.
A meeting to discuss the submission of a
Biologics License Application (BLA) took place in June 2021, after
which the Company confirmed its intention to submit a BLA, subject
to the submission of additional requested information to the FDA
and agreement on an Initial Pediatric Study Plan (iPSP).
The Company recently received feedback from the
FDA on its iPSP, submitted in July 2022. After thorough evaluation
of this feedback, which included a new request for additional data,
and taking into account the changing competitive landscape in the
treatment of hypersensitive ALL, the Company has determined that it
is in the best interests of the Company and its shareholders to no
longer seek approval for Graspa in ALL and to focus its resources
on its preclinical programs and strategic partnering
activities.
Following the sale of its production facility in
Princeton, New Jersey, for $44.5 million in April 2022, the Company
appointed a specialized advisor to evaluate strategic options to
leverage its ERYCAPS® platform with complementary assets and/or a
broader corporate transaction. Multiple options are under review,
and the Company expects to give further updates on these strategic
initiatives in the fourth quarter of this year.
About ERYTECH
ERYTECH is a clinical-stage biopharmaceutical
company developing innovative red blood cell-based therapeutics for
severe forms of cancer and orphan diseases. Leveraging its
proprietary ERYCAPS® platform, which uses a novel technology to
encapsulate drug substances inside red blood cells, ERYTECH is
developing a pipeline of product candidates for patients with high
unmet medical needs.
ERYTECH produces its product candidates for
treatment of patients in Europe at its GMP-approved manufacturing
site in Lyon, France, and for patients in the United States through
a long-term supply agreement with Catalent, operating from
ERYTECH’s former GMP facility in Princeton, New Jersey, USA.
ERYTECH is listed on the Nasdaq Global Select
Market in the United States (ticker: ERYP) and on the Euronext
regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP).
ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC
Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next
Biotech indexes.
For more information, please visit
www.erytech.com
CONTACTS
ERYTECH
Eric SoyerCFO & COO |
NewCapMathilde Bohin / Louis-Victor
DelouvrierInvestor relationsNicolas
MerigeauMedia relations |
+33 4 78 74 44
38investors@erytech.com |
+33 1 44 71 94 94
erytech@newcap.eu |
Forward-looking information
This press release contains forward-looking
statements, forecasts and estimates with respect to the clinical
results from and the development plans of eryaspase, 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. All statements contained in
this press release other than statements of historical facts are
forward-looking statements, including, without limitation,
statements regarding ERYTECH’s business and regulatory strategy and
its evaluation of potential strategic transactions. 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. 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. Important factors that could
cause actual results and outcomes to differ materially from those
indicated in the forward-looking statements include, among others,
the following: (1) the failure to achieve certain regulatory and
commercial milestones; (2) the inability to maintain the listing of
ERYTECH’s shares on the Nasdaq Global Select market and the
Euronext regulated market; (3) changes in applicable laws or
regulations; (4) the possibility that ERYTECH may be adversely
affected by other economic, business and/or competitive factors;
(5) the inability to agree to terms on a long-term supply agreement
with Catalent; and (6) other risks and uncertainties indicated from
time to time in ERYTECH’s regulatory filings. Further description
of these risks, uncertainties and other risks can be found in the
Company’s regulatory filings with the French Autorité des Marchés
Financiers (AMF), the Company’s Securities and Exchange Commission
(SEC) filings and reports, including in the Company’s 2021
Universal Registration Document (Document d’Enregistrement
Universel) filed with the AMF on April 27, 2022 and in the
Company’s Annual Report on Form 20-F filed with the SEC on April
28, 2022 and future filings and reports by the Company. 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.
- 220824_ERYTECH_Reg_Update_ALL
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