First dedicated small-molecule manufacturing line to be constructed in Visp, Switzerland
Lonza, a global leader in chemical and biological manufacturing, recently 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.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.
Rucaparib is a candidate targeting various cancer types through the inhibition of DNA-repair enzyme poly-ADP ribose polymerase-1, -2 and -3 (PARP-1, -2 and -3). The US FDA has granted the molecule Breakthrough Therapy designation for the monotherapy treatment of patients with advanced ovarian cancer with BRCA-mutated tumours and who have been treated with two or more chemotherapies.
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 online 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.
'We’re looking forward to further developing our relationship into a long and productive partnership with Clovis to supply this innovative medicine to cancer patients across the globe,' said Gordon Bates, Senior Vice President, Business Unit Head, Chemical and Microbial Manufacturing for Lonza.
'Rucaparib is a highly potent drug, where our expertise in safely handling and scaling highly potent compounds at clinical and commercial scale supported Clovis through to submission,' he added. 'This latest agreement continues to demonstrate our flexibility in developing customised supply solution for accelerated approval breakthrough designation programs to support our customers as they meet some of the greatest challenges in patient treatment.'