Biocad completes research program on darbepoetin bioanalog BCD-066

Russia’s leading biotech firm Biocad has completed the clinical research program of the first Russian dianbepoetin alpha-drug - BCD-066 - for the treatment of anemia in patients with chronic renal failure and with oncological diseases. It is planned that Russian patients will be able to receive the long-awaited bioanalog at the end of 2018.

Today darbepoetin alfa, marketed by Amgen (Nasdaq: AMGN) as Aranesp, is purchased in the framework of budget programs of state guarantees. In 2016, the state allocated about 1 billion roubles ($17.4 million) to purchase a highly effective but expensive drug darbepoetin ( HeadWay monitoring data ). According to experts, in 2017 the volume of the market in kind will grow by 15%. The cost of the preparation of Biocad production will be significantly lower than the price of foreign darbepoetin. Such price positioning will allow a larger number of patients to receive life-saving therapy with a highly effective drug, said Biocad.

For four years of the drug development, preclinical and clinical studies were conducted with the participation of more than 350 patients, including 196 patients with chronic kidney disease of the 5th stage. The results of Phase I studies and a multicenter blind Phase III study proved the equivalence of the darbepoetin alpha bioanalysis and reference preparation for all major indicators of pharmacodynamics, pharmacokinetics, efficacy, safety and immunogenicity. Biocad’s investment in the development, excluding the costs of the organization of production, amounted to more than 400 million roubles.