LYON, FRANCE--(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.
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Manufacturing Facility for MaaT Pharma’s Microbiome Ecosystem Therapies at Skyepharma’s Skyehub Bioproduction® Plant (Photo: Business Wire)
“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).
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.
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.
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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