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1 million in higher sales and marketing expenses largely due to the sales force expansion and increased marketing activities for the Gamunex IGIV CIDP indication and for Prolastin A1PI patient identification, $14.
FDA approval for its next generation A1PI product, Prolastin-C.
2 million reduction in Prolastin A1PI revenue mainly as a result of foreign exchange losses of $8.
6 million associated with the terminated CSL merger, higher sales and marketing expenses resulting from the expansion of the sales force and marketing activities for the Gamunex IGIV CIDP and Prolastin A1PI patient identification as well as increased R&D spending.
4 million in higher Prolastin-C/Prolastin A1PI sales as well as higher revenues related to Koate DVI Factor VIII (Human), and Thrombate III, partially offset by reduced contract manufacturing for Canadian Blood Services due to their multi-source strategy, as well as lower sales of albumin, hyperimmunes and PPF powder.
During the fourth quarter of 2010, Talecris initiated a clinical trial evaluating the safety and pharmacokinetic profile of two doses of Prolastin-C A1PI.
Akhtar's team will study how the destructive oxidants in cigarette smoke cause two-fold damage in the lungs by degrading elastic fibers that allow the lungs to stretch and recoil and by damaging A1PI so it does not function correctly.
TPR), which is Talecris' plasma collection platform, higher Gamunex IGIV and Prolastin-C/Prolastin A1PI revenue, as well as lower costs of production primarily driven by production mix associated with the conversion to Prolastin-C.
The primary end point of the study was a measure of overall exposure to A1PI, known as area under the plasma concentration versus time curve (AUC), measured over seven days post infusion at steady state.
In March 2010, Talecris launched its next generation A1PI product, PROLASTIN-C, in the United States.
Preliminary findings confirm the presence of a number of proteins and enzymes with applications in significant worldwide markets, including albumin, plasminogen, immunoglobulin and A1PI.