Pliva and Mayne update partnership on G-CSF and EPO

By Lisa Kerner

Erie, Pa., Feb. 22 - Pliva d.d. said it has agreed to update its joint collaboration with Mayne Pharma for development, supply and marketing of generic versions of granulocyte colony stimulating factor (G-CSF) and erythropoietin (EPO).

Clinical program costs have increased significantly beyond the scope of the original agreement bringing expected investment returns below targets, according to a company news release.

Recent guidelines and scientific advice received from the European Medicines Agency for both products contributed to the increased costs.

Although EPO has shown encouraging phase 1 results, both companies have agreed to remove EPO from their agreement. However, Pliva is discussing potential alternative collaborations on EPO in Europe with other companies.

The updated agreement is for the development, supply and marketing of G-CSF.

Pliva said its ongoing partnership with Barr Laboratories for G-CSF for Canada and the United States is not affected by the new agreement.

EPO is a generic version of Janssen-Cilag's Eprex (epoetin-alfa) primarily indicated for the stimulation of red blood cell production in patients undergoing dialysis therapy and patients undergoing chemotherapy treatment.

G-CSF, the generic version of Amgen's Neupogen (filgrastim), is indicated for the regulation of white blood cell production in the treatment of cancer patients with chemotherapy-induced neutropenia.

Pliva specializes in the discovery, development, production and distribution of generic and niche pharmaceutical products. The company is based in Zagreb, Croatia.

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