Merck KGaA, Darmstadt, Germany granted FDA Fast Track designation for development of evofosfamide

Merck KGaA, Darmstadt, Germany, a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of evofosfamide (previously known as TH-302), administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an investigational drug that is thought to be activated under severe tumor hypoxic (low oxygen) conditions, a feature of many solid tumors. The compound, currently in Phase III trials, is being developed in collaboration with Threshold Pharmaceuticals, Inc.

"Merck KGaA, Darmstadt, Germany, is focused on discovering and developing innovative new therapeutic options for cancers that are particularly difficult to treat," said Luciano Rossetti, Head of Global Research and Development of the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. "Many patients with pancreatic cancer present with advanced, inoperable tumors, and there are limited treatment options currently available for them. The Fast Track designation for evofosfamide in pancreatic cancer - the second indication for this compound to receive Fast Track designation from the FDA, following the granting of the designation in soft tissue sarcoma - will help to facilitate the timely development of this high-priority program for the biopharmaceutical business of Merck KGaA, Darmstadt, Germany."

Threshold received the first Fast Track designation for the development of evofosfamide in combination with doxorubicin for the treatment of advanced soft tissue sarcoma in November 2014.

"We are pleased that evofosfamide has been granted Fast Track status for the treatment of patients living with pancreatic cancer," said Barry Selick, Ph.D., Chief Executive Officer of Threshold Pharmaceuticals, the co-development partner of Merck KGaA, Darmstadt, Germany. "Evofosfamide is currently being studied in patients with pancreatic cancer in the MAESTRO Phase 3 study, and based on current projections, we expect that the number of protocol-specified events for the trial may be reached in the second half of 2015, with the results of the primary efficacy analyses to be available shortly thereafter."

The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs.

Pancreatic cancer is a relatively uncommon, but lethal cancer. Ranked as the 12th most common cancer worldwide, it is the 7th most common cause of cancer-related death, accounting for 4% of deaths. With 93-95% of patients dying from their disease within 5 years, pancreatic cancer has a low survival rate. There has been little improvement seen in the survival of patients with this disease over the past 30 years and there remain limited treatment options for pancreatic cancer. Surgery remains the only curative approach for pancreatic cancer; however, many patients (80-85%) present with advanced, inoperable disease. For this large group of patients ineligible for surgery, the aim of treatment is prolongation of survival and palliation of symptoms.

In the United States and Canada, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, operates as EMD Serono.