Lonza, Clovis in Cancer-Drug Supply PactBy
Lonza has formed a long-term commercial supply agreement with Clovis Oncology, a Boulder, Colorado-based biopharmaceutical company, for the manufacture of Clovis’ rucaparib, a development-stage poly ADP-ribose polymerase (PARP) inhibitor. The agreement build on an earlier relationship for the clinical manufacturing of the highly potent active pharmaceutical ingredient.
Under the agreement, Lonza will construct a new production train in Visp, Switzerland that will be exclusively dedicated to the manufacture of rucaparib. With this agreement, Lonza implements a new dedicated facility concept for small molecules, including use of on-line analytical monitoring that is designed to facilitate real-time release testing. The dedicated train guarantees access to manufacturing capacity for Clovis and allows coverage of the full range of anticipated demand scenarios for commercial supply.
The new train should be completed and operationally qualified by the beginning of 2019. Until the completion of the new train, Lonza will manufacture rucaparib in its existing facilities in Visp.
Rucaparib targets cancer types through the inhibition of DNA-repair enzyme PARP-1, PARP-2, and PARP-3. The US Food and Drug Administration has granted the molecule breakthrough therapy designation as a monotherapy treatment of patients with advanced ovarian cancer with BRCA-mutated tumors and who have been treated with two or more chemotherapies.