Pliva and Mayne amend G-CSF deal

Croatian generic drugmaker Pliva says that it has finalized an agreement with Australia's Mayne Pharma, a specialist in the development of oncology drugs, under which the companies will develop the former's biosimilar granulocyte-colony stimulating factor (G-CSF) for the European, South East Asian, Middle Eastern and Asia-Pacific markets.

The deal updates the collaboration that the two firms originally entered into in February 2005, in response to the European Medicines Agency's advice that the clinical development program be expanded.

Pliva said that G-CSF has achieved significant developmental progress and has continually met comparability milestones with Amgen's Neupogen (filgrastim) that Pliva and Mayne established at the beginning of the collaboration. Under the terms of the deal, Mayne is conducting and funding all clinical development activities and is also responsible for all regulatory filings in territories where it will market the drug. Pliva will manufacture any products that are successfully commercialized.