The new-generation drug will be used in ambulatory care for patients with severe renal impairment awaiting hemodialysis and transplantation surgery. Epolong® may become the first Russian erythropoietin slow-release drug, the full development cycle of which will be implemented in Russia. The main feature of the drug mode of action will be in gradual increase of hemoglobin levels to normal values allowing the delay of switching patients to hemodialysis and maintaining their quality of life.
The joint participation of Pharmasyntez and Pharmsynthez in the new generation drug development will bring together the efforts of Russian pharma manufacturers to meet the needs of patients with chronic kidney disease in effective medicines to control anemia. According to the registry of the Russian Dialysis Society, the annual increase in the number of patients receiving substitutive renal therapy is more than 11%. At the same time, not only patients on hemodialysis need anemia treatment, but also patients with earlier stages of chronic kidney disease, the number of which inevitably grows every year.
The agreement between Pharmasyntez and Pharmsynthez includes several steps required for conducting clinical trials, registration, and finished product launch. At the first step, the companies will proceed with a study of efficiency, safety and tolerance of the drug in patients with stage 3 and 4 chronic kidney disease, who are not on dialysis. It is planned to complete clinical trials and registration procedures until the end of year 2019.