PLIVA d.d. (LSE: PLVD) announced today that agreement has been reached to update the joint collaboration with Mayne Pharma (Mayne) for development, supply and marketing of generic versions of granulocyte colony stimulating factor (G-CSF) and erythropoietin (EPO).
In light of recent guidelines and scientific advice received from the European Medicines Agency (EMEA) for both products, clinical program costs have increased significantly beyond the scope of the original agreement bringing expected investment returns below targets. Consequently, although EPO has shown encouraging phase I results and substantial progress has been made, both companies have agreed to remove EPO from their agreement and update their continuing agreement for the development, supply and marketing of G-CSF.
PLIVA's ongoing partnership with Barr Laboratories for G-CSF for Canada and the USA is not affected by this new agreement. PLIVA is currently discussing potential alternative collaborations on EPO in Europe with a number of companies.
More information about PLIVA can be found at www.pliva.com.
ADDITIONAL NOTES: About EPO and G-CSFEPO 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. G-CSF is the generic version of Amgen’s NEUPOGEN (filgrastim) primarily indicated for the regulation of white blood cell production in the treatment of cancer patients with chemotherapy induced neutropenia.
For additional information, please contact:Marija Mandić Executive Director Investor Relations & Corporate Communications Tel: +385 1 6160 355, 6120 909 Fax: +385 1 6114 413 E-mail: Marija.Mandic@pliva.com
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. |