Pliva, Mayne Pharma finalize agreement to continue G-CSF development

By Elaine Rigoli

Tampa, Fla., July 27 - Pliva dd said it has finalized 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.

Pliva said the agreement amends the collaboration signed in February 2005 involving both G-CSF and Erythropoietin, 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.

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.

Pliva is a pharmaceuticals company with headquarters in Zagreb, Croatia.

Mayne Pharma is an oncology-focused pharmaceuticals company with headquarters in Paramus, N.J.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.