Medivir has named Linda Basse, M.D., Ph.D., as chief medical officer. The appointment puts a leader who played a starring role in the development of Darzalex in charge of ushering Medivir’s clinical pipeline through a critical period.
Basse joins Medivir from Zealand Pharma, where she served as medical director for the past 14 months. But the newly minted CMO is better known for the six years she spent at Genmab. In that time, Basse helped Genmab to bring Johnson & Johnson-partnered cancer drug Darzalex past clinical milestones and onto the market.
That experience should serve Basse well at Medivir. The Swedish biotech made its name through its own partnership with J&J. That partnership brought Olysio to market but fell apart after Gilead and its rivals transformed the treatment of hepatitis C.
Sovaldi and its ilk drove Medivir to retreat from infectious diseases and focus instead on cancer. Two years after laying off its infectious disease team, Medivir’s prospects rest on a new-look pipeline. Remetinostat, a HDAC inhibitor, is the star of this pipeline, but talks with the FDA about a planned phase 3 trial have slowed its progress.
RELATED: Medivir delays pivotal HDAC trial as FDA discussions stall
Medivir had planned to start a late-phase trial of remetinostat in patients with early-stage cutaneous T-cell lymphoma (CTCL) this year, but the slow progress of talks with the FDA has killed off that idea. Basse’s experience of interacting with the FDA could help Medivir get the project back on track.
“I am pleased to bring Linda's expansive drug development and market experience to Medivir. With her strong track record, she will be a valuable member of the management team and responsible for both the clinical strategy and development of our pipeline," Medivir CEO Christine Lind said in a statement.
The delay to the phase 3 risks undermining the promising position Medivir has established. While systemic HDAC inhibitors have been used in the treatment of advanced CTCL for more than a decade, there is a lack of formulations suited to earlier-stage forms of the cancer. Medivir thinks remetinostat can help these patients, but drugs targeting the same people are chasing it through the clinic.