Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) announced today that Medivir AB (“Medivir” or “the Company”) together with the originators of remetinostat, and TetraLogic Pharmaceuticals Corporation and The Leukemia & Lymphoma Society (”the Stakeholders”) have restructured and streamlined the financial obligations for remetinostat, a topical histone deacetylase (HDAC) inhibitor, for the treatment of cutaneous T-cell lymphoma (CTCL) and potentially other types of skin cancers. The purpose of the new agreement is to create improved business development opportunities.
Medivir acquired remetinostat from TetraLogic in 2016. The original arrangements between Medivir and the Stakeholders included milestone payments with predetermined amounts as well as royalty obligations to the Stakeholders when Medivir develops, markets or out-licenses remetinostat. The original agreement has been renegotiated so that the compensation Medivir is obliged to pay in a potential future out-licensing of remetinostat is based solely on the distribution of actual future revenues to Medivir.
It is very satisfying that we now have renegotiated a new agreement which aligns and benefits all parties and creates significantly improved conditions for a potential out-licensing or sale in our continued business development efforts related to remetinostat ", says Magnus Christensen, Interim CEO, Medivir AB.
For further information, please contact:
Magnus Christensen, Interim CEO, Medivir AB
Phone: +46 (0)8 5468 3100
Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on August 16, 2021.
Remetinostat is a topical histone deacetylase (HDAC) inhibitor. A clinical phase II study in mycosis-fungoides cutaneous T-cell lymphoma (MF-CTCL) has been completed demonstrating that remetinostat reduced severity of CTCL skin lesions with an objective response rate (ORR) of 40%. The study also showed a clinically significant reduction in the severity of pruritus (itching) in 80% of the patients. In addition, two investigator-initiated phase II studies have been conducted at Stanford University in the USA, demonstrating efficacy in both Basal Cell Carcinoma (BCC) and cutaneous Squamous Cell Carcinoma (SCC). Results from the BCC study was recently published, and publication of final data from the SCC study is now being prepared.
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 MIV-818, 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. Birinapant, a SMAC mimetic, is exclusively outlicensed to IGM Biosciences (Nasdaq: IGMS) to be developed in combination with IGM-antibodies for the treatment of solid tumors. Medivir’s share (ticker: MVIR) is listed on Nasdaq Stockholm’s Small Cap list. www.medivir.com.
This press release contains forward-looking statements related to the Company’s intentions, estimates or expectations with regard to the Company’s future results, financial position, liquidity, development, outlook, estimated growth, strategies and opportunities as well as the markets in which the Company is active. Forward-looking statements are statements that do not refer to historical facts and can be identified by the use of terms such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “will,” “may,” “implies,” “should,” “could” and, in each case, their negative, or comparable terminology. The forward-looking statements in this press release are based on various assumptions, which in several cases are based on further assumptions. Although the Company believes that the assumptions reflected in these forward-looking statements are reasonable, there is no guarantee that they will occur or that they are correct. Since these assumptions are based on assumptions or estimates and involve risks and uncertainties, actual results or outcomes, for many different reasons, may differ materially from those what is stated in the forward-looking statements. Due to such risks, uncertainties, eventualities and other significant factors, actual events may differ materially from the expectations that expressly or implicitly are contained in this press release through the forward-looking statements. The Company does not guarantee that the assumptions which serve as a basis for the forward-looking statements in this press release are correct, and each reader of the press release should not rely on the forward-looking statements in this press release. The information, opinions and forward-looking statements that expressly or implicitly are stated herein are provided only as of the date of this press release and may change. Neither the Company nor any other party will review, update, confirm or publicly announce any revision of any forward-looking statement to reflect events that occur or circumstances that arise with respect to the contents of this press release, beyond what is required by law or Nasdaq Stockholm’s rules for issuers. Potential investors should not attach undue confidence to the forward-looking information herein.