Merck Serono, a unit of German pharmaceutical manufacturer Merck, has signed a licensing agreement with US-based biotechnology firm Threshold Pharmaceuticals for the development and commercialisation of TH-302. TH-302 is Threshold’s small molecule hypoxia-targeted drug, designed to treat pancreatic cancer, which is currently in a Phase III clinical trial investigating its efficacy in patients with soft tissue sarcoma and a randomised Phase II trial in patients with advanced pancreatic cancer.
The results of the trials are expected to be announced in February 2012, and approval will see the drug pitted against Eli Lilly’s Gemzar and the Genentech, OSI Pharmaceuticals and Roche drug Tarceva.
Under the terms of the agreement, Merck will obtain co-development and exclusive global commercialisation rights, whilst Threshold will retain the option to co-commercialise the drug in the US.
Threshold will receive an initial upfront payment of $25m and additional payments totalling $35m depending on additional development milestones throughout 2012. Positive results in the drug’s Phase II pancreatic cancer trial will see Threshold receive a further $20m.
Potential milestone payments, comprising of $280m in regulatory and development and $245m in sales-based milestones, could see Threshold receive a total of $525m through the licensing agreement.
Merck Serono head of global business development and strategy Susan Jane Herbert hailed the addition of TH-302 to the company’s pipeline, adding: “Given the fact that pancreatic cancer is a very difficult to treat indication, successful Phase II results could represent important upside for our company.”