Stockholm, Sweden— Medivir AB (Nasdaq Stockholm: MVIR) announced today that its partner Infex Therapeutics, a leading anti-infectives specialist, has been granted Qualified Infectious Disease Product (QIDP) designation for MET-X by the U.S. Food and Drug Administration (FDA). MET-X is the Company’s broad spectrum Metallo-beta-lactamase inhibitor (MBLI) based on the MBLI program outlicensed by Medivir in 2017 to the AMR Centre, which changed its name to Infex Therapeutics in 2020.
QIDP designation is a U.S. incentive scheme designed to encourage the development of innovative new drugs to treat serious or life-threatening infections. The designation gives MET-X an accelerated FDA regulatory pathway, including priority review, fast-track designation and an additional five years of market exclusivity upon regulatory approval.
During 2022, Infex has presented additional preclinical data and communicated its intention to initiate regulatory safety studies to enable a Phase I clinical trial application in 2023. The QIDP designation is a significant step forward in the development of MET-X. Under the terms of the licensing agreement, Medivir is entitled to a share of potential future revenues from the MET-X programme.
For further information, please contact:
Magnus Christensen, CFO, Medivir AB
Phone: +46 (0)8 5468 3100.
Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a pro-drug designed to selectively treat liver cancer cells and to minimize side effects. Collaborations and partnerships are important parts of Medivir’s business model, and the drug development is conducted either by Medivir or in partnership. Medivir’s share (ticker: MVIR) is listed on Nasdaq Stockholm’s Small Cap list. www.medivir.com.
Infex Therapeutics Holdings plc is a leader in critical-priority infectious diseases, with a broad and diverse pipeline of innovative best-in-class and first-in-class drug candidates to address the urgent global shortage of novel anti-infective treatments. The Company is building a differentiated pipeline through in-house drug discovery, acquisition, co-development and in-licensing of early stage/pre-clinical candidates, developing them to clinical proof of concept before licensing to commercial pharma partners.