- Major milestone achieved with new state-of-the-art microbiome
facility spanning over 17,200 sq ft, completed within the 12-month
timeframe, further enhancing bioproduction capabilities and
contributing to the ecosystem in France and Europe
- MaaT Pharma is Skyepharma’s Skyehub Bioproduction® first
resident company
- The facility was designed with the intent to support MaaT
Pharma’s clinical-and commercial-scale manufacturing of Microbiome
Ecosystem Therapies
Regulatory News:
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20230911074606/en/
Manufacturing Facility for MaaT Pharma’s
Microbiome Ecosystem Therapies at Skyepharma’s Skyehub
Bioproduction® Plant (Photo: Business Wire)
MaaT Pharma (EURONEXT: MAAT – the “Company”), a
clinical-stage biotech company and a leader in the development of
Microbiome Ecosystem TherapiesTM (MET) dedicated to improving
survival outcomes for patients with cancer, and Skyepharma,
a French independent CDMO, expert in providing innovative solutions
for bioproduction as well as complex drugs development and
manufacturing, today announced that a significant development
milestone has been reached with the completion of the facility and
the transfer of MaaT Pharma’s Production and Development teams to
the new site. The companies had entered a partnership in February
2022 to build the largest cGMP1 facility, to date, for full
ecosystem microbiome therapies in Europe.
“With MaaT013, our lead asset currently in Phase 3, and MaaT033,
our second drug candidate, nearing launch in a Phase 2b clinical
study, we have reached a major milestone that will be fundamental
to securing our market access strategy. This new GMP manufacturing
facility is a testament to the continued growth of MaaT Pharma,”
stated Hervé Affagard, CEO and co-founder of MaaT Pharma.
“Thanks to our strategic partnership with Skyepharma, we have
successfully completed the new infrastructure within a year. I also
want to take the opportunity to thank the ABL Europe team who have
hosted our GMP production since 2016.”
MaaT Pharma, the leading microbiome company in oncology, is one
of the few end-to-end microbiome companies that oversees the entire
process, including innovative bioprocesses for both donor-derived
and co-cultured drug candidates in a GMP environment.
“The on-time completion of our first Skyehub facility is a major
achievement for Skyepharma and our partner MaaT Pharma. The whole
team is proud to have demonstrated the appropriate agility and
expertise to deliver this state-of-the-art building and BioCDMO
offering in the challenging 12-month timeframe,” added David
Lescuyer, CEO and President of Skyepharma. “This reliability is
an uncompromising service we want to offer to the biotech partners
that are joining us. This is an integral part of the outstanding
value accelerator that the Skyehub is providing them.”
Skyepharma is a recognized expert CDMO, offering solutions and
technologies to develop hard-to-make oral solids and addresses the
complex challenges faced by its worldwide partners to improve
patients’ lives. Backed by its strong and continuous double-digit
growth over the past 7 years, Skyepharma has continuously invested
to keep its offering ever more innovative and focused on customer
experience, and ultimately the patients. With the Skyehub
Bioproduction® model, Skyepharma can also propose a unique capacity
and service offering in the demanding bioproduction area.
The completion of this new infrastructure brings with it
positive impacts for the regional and national economy. Overall,
the partnership between MaaT Pharma and Skyepharma could lead to
the creation of a dozen jobs for specialized workers in the
industry over the coming years. These therapies demand advanced
manufacturing techniques and procedures and will contribute to the
growth of the microbiome sector in France. MaaT Pharma and
Skyepharma are currently performing quality qualification according
to GMP guidelines, with the first production campaign targeted to
start in the new plant by the end of Q3 2023.
About MaaT Pharma
MaaT Pharma, a clinical stage biotechnology company, has
established a complete approach to restoring patient-microbiome
symbiosis in oncology. Committed to treating cancer and
graft-versus-host disease (GvHD), a serious complication of
allogeneic stem cell transplantation, MaaT Pharma has launched, in
March 2022, an open-label, single arm Phase 3 clinical trial in
patients with acute GvHD, following the achievement of its proof of
concept in a Phase 2 trial. Its powerful discovery and analysis
platform, gutPrint®, enables the identification of novel disease
targets, evaluation of drug candidates, and identification of
biomarkers for microbiome-related conditions. The company’s
Microbiome Ecosystem Therapies are produced through a standardized
GMP manufacturing and quality control process to safely deliver the
full diversity of the microbiome, in liquid and oral formulations.
MaaT Pharma benefits from the commitment of world-leading
scientists and established relationships with regulators to support
the integration of the use of microbiome therapies in clinical
practice. MaaT Pharma is listed on Euronext Paris (ticker:
MAAT).
Forward-looking Statements
All statements other than statements of historical fact included
in this press release about future events are subject to (i) change
without notice and (ii) factors beyond the Company’s control. These
statements may include, without limitation, any statements preceded
by, followed by or including words such as “target,” “believe,”
“expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,”
“project,” “will,” “can have,” “likely,” “should,” “would,” “could”
and other words and terms of similar meaning or the negative
thereof. Forward-looking statements are subject to inherent risks
and uncertainties beyond the Company’s control that could cause the
Company’s actual results or performance to be materially different
from the expected results or performance expressed or implied by
such forward-looking statements.
About Skyepharma
SKYEPHARMA is an independent French pharmaceutical CDMO, 100%
owned by its management team and Bpifrance. Skyepharma is an expert
CDMO specialized in the formulation, development and manufacturing
of complex oral solid forms, with a specific expertise and
proprietary technologies on modified release products. Skyepharma
is based in Saint-Quentin-Fallavier, France. The current factory,
dedicated to its activity, occupies 22,000m², on a 60,000m² piece
of land. Skyepharma has decided to allocate a portion of the
available land to establish its SkyeHub Bioproduction, an
innovative model designed to offer clinical and commercial
production capacities to biotech companies. This SkyeHub model
includes the construction of dedicated buildings, with specifically
designed surfaces and premises, together with transverse support
services such as quality, maintenance, batch release, and other
services.
www.skyepharma.com
1 GMP: Good Manufacturing Practices is the aspect of quality
assurance that ensures that medicinal products are consistently
produced and controlled to the quality standards appropriate to
their intended use and as required by the product
specification.
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version on businesswire.com: https://www.businesswire.com/news/home/20230911074606/en/
MaaT Pharma – Investor Relations Guilhaume DEBROAS, Ph.D.
Head of Investor Relations +33 6 16 48 92 50
invest@maat-pharma.com
MaaT Pharma – Media Relations Pauline RICHAUD PR &
Corporate Communications Manager +33 6 14 06 45 92
media@maat-pharma.com
Trophic Communications – Corporate Communications
Charlotte SPITZ or Stephanie MAY +49 171 351 2733
maat@trophic.eu
Skyepharma – Investor Relations David LESCUYER President
& Chief Executive Officer +33 6 76 47 10 44
d.lescuyer@skyepharma.com
Skyepharma – Media Relations Laurent RIGAUDEAU Chief
Business Officer +33 6 30 49 22 82 l.rigaudeau@skyepharma.com
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