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PLIVA and Mayne Pharma Finalise Agreement to Continue Development of G-CSF |
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27 Jul 2006 |
PLIVA d.d. (LSE: PLVD) announces that it has finalised an agreement with Mayne Pharma (“Mayne”), a leading oncology-focused specialty pharmaceuticals company, for the continued development of biosimilar granulocyte-colony stimulating factor (G-CSF) for the European, South East Asian, Middle Eastern and Asia Pacific markets.
ZAGREB, Croatia | Jul 27, 2006 | PLIVA d.d. (LSE: PLVD) announces that it has finalised an agreement with Mayne Pharma (“Mayne”), a leading oncology-focused specialty pharmaceuticals company, 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.
More information about PLIVA can be found at www.pliva.com
For additional information, please contact:
Marija Mandić
Executive Director
Investor Relations & Corporate Communications
Tel: +385 1 6160 355
Tel: +385 1 6120 909
Fax: +385 1 6114 413
E-mail:
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This release contains certain "forward-looking statements", relating to the Group's business, which can be identified by the use of forward-looking terminology such as "will", "planned", "expectations", "forecast" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of new products expected to be introduced or have been introduced by the Group companies and anticipated customer demand for such products. Such statements reflect the current views of the Group with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the Group to be materially different from any future results that may be expressed or implied by such forward-looking statements.
SOURCE PLIVA |
