Merck Serono initiation of TH-302 Ph III trial triggers $30 million milestone for Threshold

Merck Serono, the pharma division of Germany’s Merck KGaA (MRK: DE), has initiated the global Phase III MAESTRO study, assessing the efficacy and safety of the investigational hypoxia-targeted drug TH-302 in combination with gemcitabine (Eli Lilly’s Gemzar) in patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma.

The initiation of the study resulted in US partner Threshold Pharmaceuticals (Nasdaq: THLD) earning a $30 million milestone payment from Merck under the terms of a license and co-development agreement with the German company, which includes an option for Threshold to co-commercialize in the USA. Under the terms of the deal signed last year, total potential milestone payments are $525 million, comprised of $280 million in regulatory and development milestones and $245 million in sales-based milestones (The Pharma Letter February 6, 2012).

The world market for pancreatic cancer drugs is projected to exceed $1.2 billion by the year 2015. The market is driven by sales of Eli Lilly's Gemzar (gemcitabine), the standard treatment for pancreatic cancer, as well as Genentech/OSI Pharmaceuticals/ Roche's Tarceva (erlotinib), according a report issued in 2010 by Global Industry Analysts, but since then several other drugs have been approved for this indication.