PLIVA Registers generic EPO in Croatia
PLIVA d.d. (“PLIVA”) announced today that the Croatian Agency for Medicinal Products and Medical Devices has granted approval to its subsidiary PLIVA CROATIA Ltd. to market its biogeneric erythropoietin (EPO) in Croatia. Based on MIS data, the total Croatian EPO market reached a combined market value of about USD 6m in 2004.
Željko Čović, President of PLIVA’s Management Board and CEO commented: “The registration of EPO in Croatia represents a significant milestone in PLIVA’s biological program as it demonstrates the quality and capabilities of our project team. We believe that this achievement clearly shows that PLIVA will be among the very few companies that will succeed in both developing and registering biogenerics across global markets while respecting developing regulatory rules and patent protection for these markets.”
EPO represents PLIVA’s most advanced biologics program and 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 for chronic renal failure and patients undergoing chemotherapy treatment.
PLIVA’s Biological Program
PLIVA has more than 60 years of history in the area of classical biotechnology with several successful projects started in R&D and brought to full scale production and commercialization including: yeast, antibiotics, vitamins, enzymes and veterinary vaccines. Based on this experience and knowledge, PLIVA advanced its program with very structured R&D efforts in the area of recombinant proteins – biogenerics. Currently, PLIVA's two most advanced projects are EPO and G-CSF, relying on extensive comparability studies between respective PLIVA products and respected reference products from markets of interest. Through quality of its scientific data and knowledgeable personnel, PLIVA continues to attract reputable partners such as Mayne and Barr for collaboration in this exciting field.
For additional information, please contact:Marija Mandić
Investor Relations & Corporate Communications
Tel: +385 1 6160 355
Tel: +385 1 6120 909
Fax: +385 1 6114 413
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.
- 2005-06-21 PR Epo Registration.pdf ( 62,2 KB)