PLIVA and Mayne Pharma Finalise Agreement to Continue Development of G-CSF
PLIVA d.d. announced that it has finalised an agreement with Mayne Pharma for the continued development of biosimilar granulocyte-colony stimulating factor (G-CSF) for the European, South East Asian, Middle Eastern and Asia Pacific markets.
This agreement is an amendment of the collaboration originally signed in February 2005 involving both G-CSF and Erythropoietin (EPO), which was redrawn in light of the increased clinical program costs brought on by the recent guidelines and scientific advice received from the European Medicines Agency (EMEA). G-CSF has made significant progress through development and continues to meet the product development milestones for comparability to Neupogen® set by PLIVA and Mayne.
Mayne is conducting and funding all clinical development of the product and will be responsible for regulatory filings in the territories in which it will market the product. PLIVA is completing compound development and will be responsible for manufacturing the commercial product.
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