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Medivir strengthens its clinical pipeline by entering into agreement to acquire a portfolio of clinical stage oncology programs

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Medivir AB announces that it has entered into an agreement to acquire two clinical stage oncology programs from Tetralogic Pharmaceuticals Corporation , advancing and expanding its clinical pipeline.

The acquisition includes remetinostat, a skin-directed HDAC inhibitor, and birinapant, a bivalent SMAC mimetic, and all intellectual property and data associated with Tetralogic’s HDAC inhibitor and SMAC mimetic projects.

Remetinostat Clinical Program
Remetinostat is a topical, skin-directed inhibitor of histone deacetylases (HDACs) and has a strong link to Medivir´s existing expertise in protease inhibition. The compound was designed to effectively inhibit HDACs within cutaneous lesions, but to be rapidly broken down in the bloodstream, preventing the side effects associated with systemically administered HDAC inhibitors.

Remetinostat is currently in a late phase II program aimed to treat early stage cutaneous T-cell lymphoma (CTCL), a chronic, orphan hematologic cancer that presents in the skin. There are few drugs available for the treatment of the disease, and those currently available have generally poor tolerability. As a result, patients are in need of safe and effective new treatment options which remetinostat may represent. The estimated addressable market for early-stage CTCL in the US alone is approximately USD 900m annually.

Medivir currently plans to start a phase III trial with remetinostat in the second half of 2017.

Birinapant Clinical Program
Birinapant is a bivalent, second mitochondrial activator of caspases (SMAC) mimetic that binds cellular inhibitor of apoptosis proteins (cIAPs) and induces their degradation. cIAPs are part of the ubiquitin proteasome system, and birinapant therefore ties in well to Medivir’s existing interests in modulators of protein ubiquitination. Medivir currently plans to start two different clinical studies with birinapant:

The acquisition includes the following potential payments to Tetralogic and other third party licensees:

  • Upfront cash consideration of USD 12m;
  • Remetinostat development milestones through regulatory filings of up to USD 20m;
  • Remetinostat regulatory approval milestones of up to USD 45m;
  • Remetinostat tiered royalties capped at an aggregate of 13%;
  • Additional remetinostat commercialization milestones of up to USD 31m, primarily based on substantial sales achievement levels;
  • Birinapant development milestones and research support of up to USD 20m;
  • Birinapant tiered royalties capped at an aggregate of 10%; and
  • Additional birinapant commercialization milestones of up to USD 110m, primarily based on substantial sales achievement levels.

For further information, please contact:

Niklas Prager,
CEO and President Medivir AB,
+46 8 407 6430

Ola Burmark,
CFO Medivir AB,
mobile: +46 (0) 725 480 580

Richard Bethell,
CSO Medivir AB,
mobile +46 (0)72 704 3211 

About Medivir
Medivir is a research based pharmaceutical company with a research focus on oncology and infectious diseases. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Our commercial organization provides a portfolio of specialty care pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

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