Clovis loses Servier pact, agrees to settle SEC case

Clovis Oncology
Clovis CEO Patrick Mahaffey (Clovis)

Clovis Oncology has provided updates on two tarnished drugs that were once central to its plans. The biotech is set to put the rociletinib saga to bed through a $20 million agreement with the SEC, and it will also resume development of lucitanib without the involvement of Servier.

France’s Servier sublicensed the ex-U.S. rights to lucitanib from EOS in return for €45 million ($52 million) upfront. That was in 2012. The following year, Clovis bought EOS for $200 million upfront. Clovis and Servier went on to put the drug through midphase clinical trials in breast and lung cancer, but lackluster data caused the program to stall.

Servier has now responded to the midphase data by cutting its ties to lucitanib, but Clovis thinks the drug has a future. Encouraged by the performance of a rival VEGFR1-3 drug in a PD-1 combination trial, Clovis plans to start trialling lucitanib alongside a checkpoint inhibitor. Clovis is also gearing up for a lucitanib-rucaparib trial. 

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Both trials are set to start by the end of the first quarter of 2019 and form a central part of Clovis’ near-term clinical development plan.

“We look forward to the presentation of the initial data for rucaparib in patients with germline or somatic BRCA mutation-positive metastatic castrate-resistant prostate cancer at ESMO in October, and we are actively advancing multiple combination studies for each of rucaparib and lucitanib,” Clovis CEO Patrick Mahaffy said in a statement.

Those activities could give lucitanib a new lease of life. Elsewhere, Clovis looked to close the book on another drug from its past, rociletinib. Issues regarding the disclosure of data on the once-promising lung cancer drug have dogged Clovis for the past two years and put it in the SEC’s crosshairs.

The SEC recommended taking civil enforcement action against Clovis earlier this year. Now, Clovis has reached a preliminary agreement with the agency to settle the case. Clovis recorded a $20 million charge related to the settlement in its second-quarter results, potentially enabling it to move on from a contentious part of its history.