Switzerland-based Helsinn Healthcare announced Nov. 16 it will discontinue enrollment in Phase III trials for the biliary tract tumor treatment becatecarin, a blow to Exelixis, which had licensed the small molecule drug to Helsinn in 2005.

According to Helsinn, "preliminary analysis of the Phase III data by an Independent Data Monitoring Committee indicated that the comparator agent 5-fluorouracil (5-FU) demonstrated a greater than expected survival benefit, making it statistically improbable that the final study results could achieve the planned objectives of the trial."

Under a 2005 agreement, Helsinn paid South San Francisco-based Exelixis an up-front payment of $4 mil., with additional milestones up to $21 mil. Helsinn assumed the Phase III costs from that point forward. In exchange, Exelixis granted the Swiss firm a worldwide royalty-bearing license. Exelixis retained rights to reacquire commercial North American rights to the drug.

Exelixis originally licensed becatecarin, also known as XL119, from Bristol-Myers Squibb in 2001. That year, the two firms agreed on a broad collaboration to create therapeutic oncology agents targeting defects in tumor suppressor gene pathways.

The becatecarin enrollment discontinuation is the second bit of bad news this month for Exelixis. On Nov. 2, the firm announced it was suspending patient enrollment for its tyrosine kinase inhibitor XL999, though CEO George Scangos said there were no plans to halt the Phase II trial (¹ Also see "Despite Enrollment Suspension, Exelixis Optimistic On XL999" - Pink Sheet, 3 November, 2006.).

-Jonathan M. Block (j.block@elsevier.com)

Enrollment Discontinued For Exelixis-Licensed Oncologic

More from Archive

More from Pink Sheet