Medivir, a Stockholm, Sweden-based pharmaceutical company, has agreed to acquire two clinical-stage oncology programs from Tetralogic Pharmaceuticals, a Malvern, Pennsylvania-based biopharmaceutical company in a deal valued up to $238 million.

The acquisition includes remetinostat, a skin-directed histone deacetylase (HDAC) inhibitor, and birinapant, a bivalent second mitochondrial activator of caspases (SMAC) mimetic, and all intellectual property and data associated with Tetralogic’s HDAC inhibitor and SMAC mimetic projects.

Remetinostat is currently in a late Phase II program aimed to treat early-stage cutaneous T-cell lymphoma, a chronic, orphan hematologic cancer that presents in the skin. Medivir currently plans to start a Phase III trial with remetinostat in the second half of 2017.

In addition, Medivir currently plans to start two different clinical studies with birinapant: a Phase I study in combination with Merck & Co.’s Keytruda (pembrolizumab) in patients with solid tumors, and a Phase II program in combination with platinum-based chemotherapy for treating high-grade serous carcinomas, including ovarian cancer, in collaboration with clinical investigators at the University of California, Los Angeles.

The acquisition includes an upfront cash payment, but with the majority of financial consideration tied to successful clinical development, regulatory approvals and sales milestones. Medivir will also assume agreements or certain obligations with other third parties, including the Merck & Co. agreement regarding Keytruda, subject to confirmation from Merck & Co.

Potential payments to Tetralogic and other third party licensees include an upfront cash consideration of $12 million; remetinostat development milestones through regulatory filings of up to $20 million; remetinostat regulatory approval milestones of up to $45 million; remetinostat tiered royalties capped at an aggregate of 13%; and additional remetinostat commercialization milestones of up to $31 million, primarily based on sales achievement levels. Payments also include birinapant development milestones and research support of up to $20 million; birinapant tiered royalties capped at an aggregate of 10%; and additional birinapant commercialization milestones of up to $110 million, primarily based on sales achievement levels.

The transaction is subject to confirmation by Merck & Co. of agreement transfer to Medivir, the consent of the Tetralogic senior noteholders, approval of the tetralogic shareholders, and other customary closing conditions. Medivir expects the transaction to close by year-end of 2016.

Source: Medivir