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news.Global generics and specialty pharmaceuticals company Pliva has announced that its affiliates, PAM Kft and Pliva Croatia, have entered into partnership with hospital generics firm Mayne Pharma for the development, supply and marketing of Pliva's two most advanced biologics programs.
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The biologics programs are for erythropoietin (EPO), a generic version of Amgen’s Epogen (epoetin-alfa) and granulocyte colony stimulating factor (G-CSF), the generic version of Amgen’s Neupogen (filgrastim).
Epogen is primarily indicated for the stimulation of red blood cell production in patients undergoing dialysis therapy for chronic renal failure and patients undergoing chemotherapy treatment, while Neupogen is primarily indicated for the regulation of white blood cell production in the treatment of cancer patients with chemotherapy-induced neutropenia.
Under the terms of the collaboration agreement, Pliva will receive total net proceeds of E21 million over a three-year period from Mayne, during which time Pliva will complete clinical development in collaboration with Mayne.
Mayne will receive exclusive marketing and distribution rights for the majority of West European markets, and other countries in the Middle East, North Africa and Asia Pacific. Pliva will retain full rights for CEE (including the 10 EU accession countries), the Americas, and Japan where it can market the products itself or with business partners.
Pliva will also be the exclusive supplier of these products to Mayne through a mutually attractive pricing arrangement which is adjusted according to the level of sales volumes and margins achieved.
“We are especially pleased to have entered into this partnership with Mayne,” commented Zeljko Covic, president of Pliva’s management board and CEO. “We are convinced that with Mayne’s strong and established hospital sales force promoting Pliva’s quality products, both companies will successfully profit from this multi billion dollar market, while providing a more affordable solution to patients across the globe.”
Following extensive clinical trials in Croatia, Pliva has already submitted a generic EPO for registration in Croatia that is planned for launch this year.