After benefiting from the improved profitability of the drug Nephoxil, Panion & BF Biotech Inc. (PBF) announced that the new dosage form and new indication of Nephoxil for iron-deficiency anemia had been successfully unblinded in phase III trials in Taiwan, with significant differences in primary and secondary efficacy indicators.
Approximately 70% of dialysis patients have both hyperphosphatemia and iron deficiency anaemia, and approximately 30%-40% of patients with chronic kidney disease (non-dialysis) have iron deficiency anaemia. PBF has been extended to both renal and non-renal indications and is already marketed in the US and Japan. It is currently the only phosphorus combination for the simultaneous treatment of hyperphosphatemia and iron deficiency anaemia in renal patients worldwide.
It is expected that because of the expiration of the patents of Nephoxil, it will no longer be necessary to pay profits to the inventor, and because of the over-recognized expenses, it will have the opportunity to rebound in the fourth quarter, driving the gross margin back up.
The Phase III trial was conducted in 12 centres in Taiwan, with a total of 141 patients with chronic renal disease suffering from iron deficiency anaemia.
In addition to the success of the Phase III clinical trial in Taiwan, sales in the US and Japan will continue to grow by double digits this year, while European licensing deals are also undergoing and will be finalized in the second half of the year at the earliest. This will lead to a new record in revenue and profitability.