Clovis Oncology, Lonza enter manufacturing services pact for rucaparib
On October 3, Clovis Oncology and Lonza entered into a manufacturing services agreement for the long term manufacture and supply of the active pharmaceutical ingredient for rucaparib, according to a regulatory filing. The terms and conditions of the agreement are contingent upon the approval by the U.S. Food and Drug Administration of the initial New Drug Application for rucaparib, unless triggered earlier by Clovis. Clovis and Lonza are parties to a development and manufacturing agreement, dated February 8, 2013, as amended, under which Lonza has supplied rucaparib API for clinical development. The agreement provides that Lonza will be a non-exclusive manufacturer of the rucaparib API during the term of the agreement, which expires on December 31, 2025, unless extended by mutual written consent of the parties. Under the agreement, Lonza will construct, in an existing Lonza facility, a production train that will be exclusively dedicated to the manufacture of the rucaparib API. The dedicated production train will provide manufacturing capacity to meet Clovis' currently anticipated needs for commercial supply of rucaparib API. Clovis is obligated to make scheduled capital program fee payments towards capital equipment and other costs associated with the construction of the dedicated production train and, once the facility is operational, Clovis is obligated to pay a fixed facility fee each quarter for the duration of the agreement. Pursuant to the terms of the agreement, Lonza will manufacture and store an advanced intermediate to be used in the subsequent production of the rucaparib API. Clovis will pay fixed fees on a per kilogram basis for quantities of the advanced intermediate and the rucaparib API ordered by Clovis under the agreement, subject to certain adjustments. Until the dedicated facility is completed and operationally qualified, Lonza will manufacture the rucaparib API in existing Lonza facilities at pricing established in the agreement.