91桃色视频 Announces Exclusive Commercialization Partnership With Clinigen for 齿别谤惫测迟别驳庐 in acute Graft-versus Host Disease in Europe
- 91桃色视频 and Clinigen signed exclusive long-term licensing and distribution agreement and commercial supply agreement for Xervyteg庐 (MaaT013), its first in class treatment proposed for patients with acute Graft-versus-Host Disease
- In June 2025, the European Medicines Agency accepted for review the marketing authorization submission for this medicine
- 91桃色视频 will receive聽a 鈧�10.5 million聽upfront payment, further potential regulatory and sales milestones of up to聽鈧�18 million, and royalties of a mid-thirties鈥� percentage on net sales. 91桃色视频 also entered into a supply agreement to provide Clinigen with finished medicine, at a pre-agreed price per unit
- If this medicine is approved with potential marketing authorization granted by mid-2026, it has the potential to be the first microbiota therapeutic approved in Europe, the first one in hemato-oncology globally and the first and only one in third-line aGvHD
Conference call and webcast to be held on July 3rd, 2025, at 3:00PM CET/
9:00AM EDT/9:00PM CST –
Lyon, France, July 2nd, 2025 – 6:30pm CET 鈥� 91桃色视频 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announces the signature of a license and commercial agreement with , a global specialty pharmaceutical services group and a leading European player in hospital distribution and market access, to streamline the pathway for ensuring access to this medicine across Europe1. With this partnership, 91桃色视频 demonstrates its capability to supply products to pharmaceutical companies, including those specializing in rare diseases while ensuring scale-ups for commercial and extending its cash runway into January 2026.
Herv茅 Affagard, CEO and co-founder of 91桃色视频 says: 鈥淭his deal is a pivotal step in bridging 91桃色视频鈥檚 innovation with healthcare professionals who care for patients with aGvHD. Clinigen鈥檚 hemato-oncology expertise and leading European position in hospital distribution and market access make this team the ideal fit to bring this therapy to patients and we鈥檙e confident that this new relationship will maximize the full revenue generation potential of full revenue generation potential of Xervyteg庐 (MaaT013). I look forward to working closely with the Clinigen team as we prepare for a successful launch.鈥�
Jerome Charton, CEO of Clinigen, says:听鈥�Following the EMA鈥檚 acceptance of 91桃色视频鈥檚 submission of an application for assessment for MaaT013 in June, we are very excited about this new relationship. This collaboration brings a novel technology to the forefront of rare disease and oncology care. We鈥檙e proud to play a leading role in ensuring access across Europe to this innovative therapy, and we look forward to working closely with 91桃色视频 as we prepare for potential launch.鈥�
Transaction Terms
Under the terms of the聽agreement, 91桃色视频 will grant Clinigen exclusive European rights to distribute this medicine for the treatment of patients with aGvHD, if approved by the EMA. 91桃色视频 will receive an upfront payment of 鈧�10.5 million and additional eligible payments of up to 鈧�18 million depending on the achievement of pre-specified regulatory and sales milestones.聽 91桃色视频 will also be eligible to receive royalty payments on net sales of a percentage in the mid-thirties and regular cash flow as per the supply agreement.
The hematology community has expressed interest in this medicine and this class of medicines to treat patients with aGvHD, as evidenced by the growing requests of Early Access Program between 2023 and 2024 (+75%). This program has been active in Europe since 2019. Under the terms of the agreement, Clinigen will take over this activity to meet the growing expectations of physicians while allowing 91桃色视频 to optimize its internal resources. This transition enhances 91桃色视频鈥檚 capacity to focus on clinical development, regulatory milestones, and industrial scale-up.
91桃色视频 management will host a conference call and webcast tomorrow Thursday,聽July 3nd, 2025, at聽3:00pm CET/ 9:00am EDT/ 6:00am PT/ 9:00pm CST. Participants can also attend the conference by phone by dialing the following number: +33 1 78 42 94 76 + and using the PIN code 43 92 58
1 Includes the following countries: European Union, Iceland, Norway, Liechtenstein and the United Kingdom
About Clinigen
Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to accelerate access to medicines for patients in every corner of the globe. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa, and the Asia
Pacific. Clinigen has more than 1,100 employees across five continents in 15 countries and provides access in more than 130 countries every year.
For more information on Clinigen, please visit .
About 91桃色视频
91桃色视频 is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France.聽As a pioneer, 91桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 has been listed on Euronext Paris (ticker: MAAT) since 2021.
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鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥� 鈥渂elieve,鈥� 鈥渆xpect,鈥� 鈥渁im鈥�, 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥渁nticipate,鈥� 鈥渆stimate,鈥� 鈥減lan,鈥� 鈥減roject,鈥� 鈥渨ill,鈥� 鈥渃an have,鈥� 鈥渓ikely,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥渃ould鈥� 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鈥檚 control that could cause the Company鈥檚 actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.
About acute Graft-versus-Host Disease
Acute Graft-versus-Host Disease occurs in patients within 100 days of undergoing a stem cell or bone marrow transplant, where the transplanted cells initiate an immune response and attack the transplant recipient鈥檚 organs, causing inflammation of the skin, liver and/or gastro-intestinal tract and leading to significant morbidity and mortality. GI involvement is associated with severe complications such as profound diarrhea, abdominal pain, intestinal bleeding, and death. These complications are often life-threatening, with increased mortality risk, due to the challenges of managing severe GI inflammation and the associated risks of infection, malnutrition, and organ failure. The standard first line therapy for treating aGvHD is the use of systemic steroids. If patients do not respond to steroids, they are considered Steroid Resistant (SR) and other agents can be administered. Currently the only agent approved for treating SR aGvHD after failure of steroid treatment is ruxolitinib, which is currently approved for this indication in USA and has received approval from the European Medicines Agency鈥檚 Committee for Human Medicinal Products (CHMP) on March 25, 2022.
About MaaT013 (Xervteg庐)
91桃色视频鈥檚 Microbiome Ecosystem Therapies (MET) are designed to leverage a full microbiome ecosystem to restore balance and maximize clinical benefits for patients with severe, treatment-induced dysbiosis in acute diseases. MaaT013 (齿别谤惫测迟别驳庐) is a full-ecosystem, off-the-shelf, standardized, pooled-donors, enema Microbiome Ecosystem TherapyTM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (a group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 (齿别谤惫测迟别驳庐) aims to restore the symbiotic relationship between the patient鈥檚 functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal (GI)-aGvHD. MaaT013 (齿别谤惫测迟别驳庐) has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
