Croatian drugmaker Pliva has scaled down its near-term ambitions in the nascent market for biosimilar or follow-on biologic drugs, ending an agreement with Mayne Pharma on the development of a ‘biogeneric’ version of erythropoietin (EPO).
EPO, a generic version of Johnson & Johnson unit Janssen-Cilag's Eprex (epoetin alfa) is used to stimulate red blood cell production in patients undergoing renal dialysis and those having chemotherapy.
Pliva said the decision was taken because clinical programme costs have increased significantly beyond the scope of the original agreement with Mayne, mainly as a result of recent guidelines and scientific advice received from the European Medicines Agency (EMEA).
And the move comes despite the fact that EPO has shown encouraging Phase I results, said Pliva. The Croatian firm is currently discussing potential alternative collaborations on EPO in Europe with a number of companies.
Pliva and Mayne will continue their agreement to develop a biosimilar version of granulocyte colony stimulating factor, a generic version of Amgen's Neupogen (filgrastim) for the regulation of white blood cell production in the treatment of cancer patients with chemotherapy-induced neutropenia. This project is also affected by the new EMEA guidelines, but is thought to be a more appealing project commercially than EPO.
Pliva also has a partnership with Barr Laboratories for G-CSF in the USA and Canada, but this is unaffected by the decision.