Medivir rounds out oncology portfolio with new deal
- Following its decision to focus on cancer, Stockholm-based Medivir has snagged the rights to two of Tetralogic's clinical stage oncology products in return for up to $238 million in upfront cash, and clinical development, regulatory approvals and sales milestones, as well as tiered royalties of up to 13%.
- The lead of the two products is remetinostat, a local treatment for early stage cutaneous T-cell lymphoma (CTCL). This is in Phase 2, with Phase 3 trials planned for the second half of 2017.
- Medivir has two clinical trials planned for birinapant: a Phase 1 combination study with Merck & Co.'s Keytruda (pembrolizumab) in solid tumors and a Phase 2 with platinum-based chemotherapy in high-grade serous carcinomas (HGSCs), including ovarian cancer.
Last month, Medivir announced that it would be switching its focus around to cancer. Its deal with Tetralogic, gaining access to two cancer drugs already in the clinic, has shown that it is putting these plans into action. If everything goes as expected, the deal will be worth almost $240 million plus up to double digit royalties, and shifts the balance of Medivir's pipeline towards clinical development from R&D.
"These assets are complementary to our oncology efforts in early phases. Both programs have an excellent fit with the Medivir scientific platforms and we are uniquely positioned to recognize the value of both of Tetralogic’s clinical assets," said Niklas Prager, CEO & president of Medivir.
The next step will be to move remetinostat, a skin-directed inhibitor of histone deacetylases (HDACs), into Phase 3 in the chronic and rare cancer early stage CTCL. This has few treatment options, and could be a market worth $900 million a year in the U.S. There are two studies planned for birinapant, a bivalent, second mitochondrial activator of caspases (SMAC) mimetic.
A Phase 1 study will look at whether birinapant can enhance the activity of Keytruda, and this could be an interesting market as the use of PD-1 inhibitors grows. A Phase 2 study will focus on ovarian cancer and other high-grade serous carcinomas (HGSCs) in combination with platinum-based chemo. The drug could have particular application in patients with platinum-resistant disease, an area of unmet need.
Medivir has sold its subsidiary BioPhausia to Karo Pharma, which has netted it SEK908 million ($100.7 million). This, along with the savings made with the refocus and out-licensing of non-core programs, could help to fund Medivir's other attempts to bolster up its currently very sparse oncology pipeline.
"Medivir has a track record of discovering and developing drugs that are targeted to specific tissues, so we are well placed to rapidly progress remetinostat for the treatment of early-stage CTCL. Many patients with this disease are urgently in need of new treatments that are both safe and effective. We also believe that birinapant, through its effects on both immune and tumor cells, offers the potential to improve the treatment of a number of different cancers. We look forward to rapidly advancing both of these agents into the next round of clinical studies," said Richard Bethell, CSO of Medivir in a statement.
- Medivir Statement
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