In a significant disappointment for the German pharma and life sciences company, Merck KGaA (MRK: DE) today announced that it is not planning to file for approval of evofosfamide in advanced soft tissue sarcoma and advanced pancreatic adenocarcinoma.
The decision was made in light of results from two Phase III studies of evofosfamide in combination with chemotherapy in these two types of cancer, as reported by partner Threshold Pharmaceuticals (Nasdaq: THLD). Merck says it will now be redeploying its resources into high-profile future products, such as avelumab and all other priority programs in oncology, immuno-oncology and immunology. Merck’s shares were barely affected by the news, dipping just 0.9% to 91.69 euros in morning Frankfurt trading.
Merck had high expectations for both evofosfamide and avelumab, and R&D chief Luciano Rossetti said in an exclusive interview with The Pharma Letter that the company hoped to launch both as early as end-2016 (TPL August 17). Evofosfamide has already been granted orphan drug status by the US Food and Drug Administration and the European Commission. In addition, the FDA has also granted fast track designation. Analysts at Baader-Helvea had expected the drug to generate peak annual sales of 500 million euros ($543 million).
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