- Integrated solution for process development and manufacturing of drug substance and drug product will facilitate the advancement of clinical development
- The agreement meets Allarity’s needs for current and future commercial production of dovitinib and will support the Company’s planned NDA filing in 2021
Basel, Switzerland and Hoersholm, Denmark, 23 September 2021 – Allarity Therapeutics A/S, a clinical-stage precision medicine company actively advancing a pipeline of in-licensed oncology therapeutics for patients with difficult-to-treat cancers, and Lonza, a CDMO partner to the biopharma industry, today announced an agreement to develop and manufacture dovitinib. The agreement aims to commence manufacturing of dovitinib in 2022 to meet Allarity’s projected needs for bringing dovitinib to market following anticipated regulatory approvals.
Dovitinib represents Allarity’s most advanced clinical asset, targeting metastatic renal cell carcinoma (RCC) with possible use in other indications, such as liver cancer, breast cancer and various solid tumors. This pan-tyrosine kinase inhibitor targets fibroblast growth factor receptor, vascular endothelial growth factor receptor and other receptor tyrosine kinases.
Steve Carchedi, CEO, Allarity commented: “Entering this agreement with Lonza is an important step in our long-term preparations to take dovitinib towards commercialization. Allarity now has a robust agreement covering the production and ongoing supply of dovitinib that we will need in the years to come.”
Under the terms of the agreement, Lonza will leverage its capabilities for commercial manufacturing of small-molecules and oral solid dosage forms to provide Allarity with cGMP compliant drug product supply and regulatory support towards commercialization. Allarity will leverage Lonza’s global network, technical capabilities, and integrated solution covering both drug substance and drug product. The drug substance manufacturing and particle size reduction by micronization will be performed at Lonza’s facility in Visp (CH). The drug product manufacturing will take place at the Tampa, FL (US) facility.
Christian Dowdeswell, VP and Global Head, Commercial Development – Small Molecules, Lonza, added: “Our collaboration with Allarity Therapeutics demonstrates our commitment to supporting companies with their development pipeline. Our unique and comprehensive set of capabilities supporting drug substance through to drug product development and manufacturing enable Allarity to focus on dovitinib commercialization.”