Date: 2016-10-27
Type of information: Production agreement
Compound: rucaparib
Company: Clovis Oncology (USA - CO) Lonza (Switzerland)
Therapeutic area: Cancer - Oncology
Type agreement: manufacturing bioproduction
Action mechanism: enzyme inhibitor/PARP inhibitor. Rucaparib is an orally-available, small molecule PARP 1 (poly ADP-ribose polymerase) and PARP2 inhibitor being developed for the treatment of platinum-sensitive ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, commonly referred to as “BRCA-like” or “BRCAness.”
Disease: ovarian cancer
Details: * On October 27, 2016, Lonza announced that it has entered into a long-term commercial supply agreement with Clovis Oncology, a biopharmaceutical company developing and commercializing innovative cancer treatments, for the manufacture of Clovis’s development-stage PARP inhibitor, rucaparib (Rubraca®). The focus of the agreement is to provide Clovis with security of supply and the flexibility to react swiftly to changes in market demand scenarios. Both companies are strengthening their relationship after a successful collaboration on clinical manufacturing of the highly potent API.
Under the agreement with Clovis, Lonza will construct a new production train in Visp (CH) that will be exclusively dedicated to the manufacture of rucaparib. With this agreement Lonza implements a new dedicated facility concept for small molecules using modern technologies, including extensive 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.
By the beginning of 2019, the new train should be completed and operationally qualified. Until the completion of the new train, Lonza will manufacture rucaparib in its existing facilities in Visp with dedicated access to capacity. The agreement represents a comprehensive supply strategy supporting the customers ongoing business needs through commercialization and ongoing market supply.
Financial terms:
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