Medivir enters exclusive licensing agreement with Biossil, Inc. for remetinostat

Summary by AI ^BETAClose X

Medivir AB has granted Biossil, Inc. exclusive global development rights for remetinostat, a topical HDAC inhibitor, which has shown positive Phase 2 data in basal cell carcinoma and cutaneous T-cell lymphoma. Under the licensing agreement, Medivir is eligible to receive payments up to approximately USD 60 million if remetinostat is successfully developed and approved. Additionally, Medivir will receive mid-single digit royalties on future net sales of the drug. Biossil plans to resume development of remetinostat, aligning with its clinical potential.

Disclaimer*

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announces today that it has entered into an exclusive licensing agreement, through which Biossil, Inc. will receive global, exclusive development rights for remetinostat, a clinical-stage topical HDAC inhibitor. Biossil is a Toronto-based AI-native drug developer focused on developing novel therapies for heterogenous diseases with urgent unmet medical needs.

Remetinostat has shown positive phase 2 data in basal cell carcinoma (BCC) as well as cutaneous T-cell lymphoma (CTCL). The terms of the agreement entitle Medivir, should remetinostat be successfully developed and approved, to receive payments up to a total of approximately USD 60 million, in addition to mid-single digit royalties on future net sales.

- “Agreements, such as the one announced today with Biossil, continue to be a core component of Medivir’s corporate mission and business model,” said Jens Lindberg, Chief Executive Officer of Medivir. “Today’s announcement further exemplifies our focus and commitment to the development and commercialization of innovative treatments for cancer, and we look forward to Biossil’s progress with remetinostat in the clinic and beyond.”

- “Remetinostat was identified with the same rigorous approach applied to all of Biossil candidates,” said Dr. Alexander Mosa, Co-Founder, Chief Scientific Officer and Chair of Biossil. “It meets our key criteria of promising clinical data, differentiated mechanism of action, and potential to address important unmet need. We are fortunate to have a supportive partner in Medivir, and we will resume development and advance remetinostat in accordance with its clinical potential.”

About remetinostat
Remetinostat is a topical histone deacetylase (HDAC) inhibitor. Three clinical phase II studies, demonstrating remetinostat efficacy and safety, have been completed. The phase II study in mycosis-fungoides cutaneous T-cell lymphoma (MF-CTCL) showed reduced severity of CTCL skin lesions with an objective response rate (ORR) of 40% and 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 cutaneous Squamous Cell Carcinoma (SCC), and showing 70% ORR and >50% complete histologic resolution in Basal Cell Carcinoma (BCC).

About Medivir
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 drug candidate designed to selectively treat cancer cells in the liver 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.