The Ministry of Health of the Russian Federation has authorized the first Russian originator for the treatment of multiple sclerosis developed by the scientists of the biotechnology company BIOCAD. The medicinal product was given the trade name Ivlizi® (INN: divozilimab). The launch of a Russian originator can significantly increase the efficacy of therapy and the patients’ quality of life.
BIOCAD’s innovation is a next-in-class monoclonal antibody product. The principle of action of divozilimab is based on its ability to detect and bind the CD20 antigen located on the surface of certain white blood cells, B-cells playing a major role in the damage to the nervous tissue in multiple sclerosis. It is B-cells that attack and cause damage to the myelin sheath of the nerve cells. In turn, by binding B-cell CD20 receptors, divozilimab causes depletion of the pool of these cells, which leads to a reduction of immune inflammation in the central nervous system and decrease in the number of relapses in patients with multiple sclerosis accordingly.
Pavel Yakovlev, Vice President, Early-Stage Development and Research, BIOCAD:
Divozilimab is the first Russian original anti-CD20 monoclonal antibody. The improved molecular formula (afucosylation of the Fc region) indirectly leads to an increase in the anti-B-cell response and, as a result, a more pronounced depletion of the pool of B-cells, while the ability to restore B-cells and the existing humoral immunity remain intact. At the same time, divozilimab does not affect innate immunity and the total T-cell count. The dosing regimen of the drug is once every six months.
Divozilimab became the tenth originator in BIOCAD’s portfolio. The efficacy and safety of the drug have been studied in nonclinical and clinical studies in full compliance with international standards. Although all stages of clinical studies required for marketing authorization of the drug have now been completed, participants of phase 2 and 3 studies continue to receive divozilimab in an extended phase 3 and the EXTENSION study, which aims to evaluate the long-term efficacy and safety of the drug. This assessment is especially important because multiple sclerosis requires lifelong therapy.
It should be noted that nonclinical and phase 1 and 2 clinical studies of divozilimab were implemented with the company’s own funds and with the state support. In particular, in 2019 and 2020, BIOCAD received subsidies from the Russian Ministry of Industry and Trade in the amount of 16.3 million rubles (equivalent to USD 210.000). The funds were used to investigate the first Russian original disease-modifying therapy for multiple sclerosis. BIOCAD’s own investments in the development and research of Ivlizi® amounted to more than 660 million rubles (equivalent of USD 8.5mln).
According to experts, there are more than 150,000 Russian patients with multiple sclerosis, an autoimmune disease that causes damage to the sheath of the nerve fibers. The disease onset can be sudden and it can lead to impaired motor activity and complete paralysis. To slow the disease progression, patients take lifelong disease-modifying therapies for multiple sclerosis.
The biotechnology company BIOCAD has been researching new options for the treatment of multiple sclerosis for more than 10 years. The company’s product portfolio includes six drugs for this disease.