TH-302 is in Phase II and III trials for a range of solid and hematologic cancers.

Merck KGaA is paying Threshold Pharmaceuticals €19 million (about $25 million) up front as part of a deal to co-develop and commercialize the latter’s late-stage anticancer drug TH-302. The small molecule hypoxia-targeted drug is currently undergoing a Phase III trial as combination therapy with doxorubicin in patients with soft tissue sarcoma and Phase II evaluation in patients with solid tumors and hematologic cancers.

Under terms of the deal Merck receives co-development rights and exclusive global commercialization rights to TH-302. Threshold will have primary responsibility for developing the drug for the soft tissue sarcoma indication in the U.S. and will work jointly with Merck to develop the drug on all other cancer indications. Merck will pay 70% of worldwide development costs.

Threshold retains an option to co-commercialize TH-302 in the U.S. and could earn up to another €26.5 million ($35 million) in milestone payments during 2012, plus a €15 million ($20 million) milestone payment pending positive data from a Phase II study investigating TH-302 as combination therapy with gemcitabine in the treatment of pancreatic cancer. Topline data from this 214-patient trial is expected this month.  

“The addition of TH-302 to our pipeline provides an important opportunity in several different tumor types to expand our oncology development program,” comments Susan Jane Herbert, head of global Business development and strategy at Merck Serono. “Given the fact that pancreatic cancer is a very difficult to treat indication, successful Phase II results could represent important upside for our company.”

TH-302 is designed to convert into its DNA alkylating form, dibromo isophoramide mustard, specifically within hypoxic tumor cells. The drug has been investigated in over 550 patients in Phase I/II clinical trials in a broad spectrum of tumor types, both as a monotherapy and in combination with chemotherapy treatments and other targeted cancer drugs.

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