MaaT Pharma and Clinigen Sign Exclusive European Licensing Deal for Xervyteg® in Acute Graft-Versus-Host Disease

03 July 2025 | Thursday | News

Europe-focused agreement grants Clinigen rights across the EU, UK, and EEA, securing up to €28.5 million for MaaT Pharma as EMA reviews the first-in-class microbiota therapy targeting third-line aGvHD

  • MaaT Pharma and Clinigen signed exclusive long-term licensing and distribution agreement and commercial supply agreement for Xervyteg® (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
  • MaaT Pharma will receive a €10.5 million upfront payment, further potential regulatory and sales milestones of up to €18 million, and royalties of a mid-thirties’ percentage on net sales. MaaT Pharma 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

 

MaaT Pharma (EURONEXT: MAAT – the “Company”), 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,  announces the signature of a license and commercial agreement with Clinigen, 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, MaaT Pharma 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.

Hervé Affagard, CEO and co-founder of MaaT Pharma says: “This deal is a pivotal step in bridging MaaT Pharma’s innovation with healthcare professionals who care for patients with aGvHD. Clinigen’s 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’re confident that this new relationship will maximize the full revenue generation potential of full revenue generation potential of Xervyteg® (MaaT013). I look forward to working closely with the Clinigen team as we prepare for a successful launch.”

Jerome Charton, CEO of Clinigen, says: “Following the EMA’s acceptance of MaaT Pharma’s 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’re proud to play a leading role in ensuring access across Europe to this innovative therapy, and we look forward to working closely with MaaT Pharma as we prepare for potential launch.”

Transaction Terms

Under the terms of the agreement, MaaT Pharma will grant Clinigen exclusive European rights to distribute this medicine for the treatment of patients with aGvHD, if approved by the EMA. MaaT Pharma will receive an upfront payment of €10.5 million and additional eligible payments of up to €18 million depending on the achievement of pre-specified regulatory and sales milestones. MaaT Pharma 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 MaaT Pharma to optimize its internal resources. This transition enhances MaaT Pharma’s capacity to focus on clinical development, regulatory milestones, and industrial scale-up.

MaaT Pharma management will host a conference call and webcast tomorrow Thursday, July 3nd, 2025, at 3:00pm CET/ 9:00am EDT/ 6:00am PT/ 9:00pm CST. To register, please click here.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

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