Exelixis and Helsinn sign development agreement for XL119

US genomics-based drug discovery company Exelixis and privately owned pharmaceutical group Helsinn Healthcare, of Switzerland, have reached an agreement for the development of XL119 (becatecarin).

Under the terms of the agreement, Helsinn will pay Exelixis an upfront payment of US$4m and additional milestones up to $21m. In addition, Helsinn will assume the cost of the Phase III programme going forward.

In return, Exelixis has granted to Helsinn a worldwide, royalty-bearing license to XL119. Exelixis has retained rights to reacquire commercial rights to XL119 for North America, and will receive milestones and royalties on sales in the rest of the world.

XL119 is currently in a multi-national Phase III clinical trial at approximately 50 centres in North America and Europe. The primary endpoint of the 600-patient trial is increased survival of patients with bile duct tumors treated with XL119 compared with the chemotherapy agents 5-fluorouracil (FU) and leucovorin. The trial is currently recruiting and enrolling patients and is on track to be completed as planned. XL119 was granted Orphan Drug status in the US in March last year.

'Through the development of XL119, we aim to create a new standard of care for patients with biliary tract cancers, a rare and aggressive form of cancer with a high medical need and very limited survival,' said Enrico Braglia, managing director of Helsinn. 'We believe that XL119 will offer a meaningful therapeutic benefit over currently used therapies and will become the therapy of reference for biliary tract cancer patients worldwide.'