Israeli biopharmaceutical company BioLineRx Ltd. said its cancer therapy Motixafortide received an orphan-drug tag from the European Medicines Agency as a treatment for pancreatic cancer.
The medicine, also called BL-8040, received the same designation from the U.S. Food and Drug Administration in 2019. Orphan medicines are meant to treat conditions that affect a smaller segment of the population — in the EU's case, less than five in 10,000 people.
Pancreatic cancer accounts for 3.2% new cases in the U.S. Each year, about 185,000 individuals globally are diagnosed with the condition, and an estimated 55,000 individuals were diagnosed with pancreatic cancer in the U.S. in 2018.
The tag grants regulatory and financial incentives for companies to develop and market therapies that can either treat orphan conditions or offer a significant benefit over existing medicines for these diseases. The grant also provides for market exclusivity of a drug if it is ultimately approved.
BioLineRx CEO Philip Serlin said in a Jan. 14 news release that the orphan-drug tag in the EU was the result of the initial data readout from a portion of an ongoing phase 2a study called Combat/Keynote-202 in second-line metastatic pancreatic cancer patients.
The company is studying Motixafortide in combination with Merck & Co. Inc.'s Keytruda and chemotherapy.