PharmaEngine’s global partner, Servier, applied the Type II Variation of ONIVYDE to the European Medicines Agency (EMA). EMA has accepted the application. The new indication is using ONIVYDER in combination with oxaliplatin, 5-fluorouracil and leucovorin as first line treatment for patients with metastatic adenocarcinoma of the pancreas.

Name of the product: NAPOLI-3. Indication: in combination with oxaliplatin, 5-fluorouracil and leucovorin for the first line treatment of patients with metastatic adenocarcinoma of pancreas. The next step in development: file post-approval change for a new indication. Current stage of the Research and Development.

Post-approval change in indication, drug administration and dosage Future direction if it receives the approval from Governmental Authority: Servier’s sales team will be responsible for the sales in Europe while PharmaEngine’s sales team will be responsible for the sales in Taiwan.