Darbesty Biocad

2019: Obtaining registration certificate

On April 1, 2019 the biotechnology company BIOCAD announced obtaining the registration certificate on medicine from MNN darbepoetin an alpha — the domestic bioanalogue intended for therapy of anemia at a chronic renal failure. The company intends to occupy during 2019 a half of the market on all class of medicines. Medicine will go on sale in the next 30 few days. Investment volume into development was over 400 million rubles.  

The provided medicine is intended for treatment of patients with anemia at the chronic renal failure (CRF) and also at effects of himioterapiinemiyeloidny malignant new growths. Darbepoetin an alpha is considered the gold standard of therapy of these diseases. First of all, medicine is shown to the people who are on replacement kidney therapy (i.e., receiving dialysis or living with a kidney transplant) inuzhdayushchimsyav corrections of level of hemoglobin in blood. Medicines of this class spread according to the VED federal programs (vital and essential drugs) and ONLS (the list of providing necessary medicines).

Darbestim   — bioanalog a darbepoetina an alpha, recombinant human erythropoietin of the prolonged action. It is made in cells of ovaries of the Chinese hamster (CHO-K1) s by use of gene technology, works by analogy with endogenous human erythropoietin, but thanks to minor changes in the structure has more long action that allows to reduce medicine introduction frequency.

By estimates of analysts of the company, market capacity only on medicines from MNN darbepoetin is about one billion rubles if to speak about all drugs intended for treatment of nefrogenny anemia, then the speech can go about 3-4 billion rubles. By calculations of analysts of the company, medicine sales volume at the end of 2019 will reach 700 million rubles.darbepoetin an alpha is included in the Russian standards of therapy and clinical recommendations, and Darbestim has sufficient potential to become the main medicine, having occupied at least 50% of the market, consider in BIOCAD. Introduction of domestic medicine to civil circulation will allow to reduce the cost of therapy of this nosology significantly. The bioanalogue from BIOCAD is capable to give high quality and efficiency at the level of an originator, and at the same time to support rather low price capable to increase security with medicine in regions.

Reliability of domestic medicine is confirmed with clinical trials.

"Features of a molecule of a darbepoetin provide the prolonged action in comparison with short erythropoietins that allows to reduce the frequency of injections of medicine at lower price. Emergence in the market of the Russian bioanalogue of a darbepoetin the alpha will make effective modern treatment more available to patients through the whole country". Roman Ivanov, vice president for developments and researches BIOCAD

In the company worked on medicine from 2010 to 2019.

As reported in BIOCAD, clinical trials of a bioanalogue were conducted in a full compliance with all Russian and international regulatory requirements. Patients were recruited in 23 largest medical centers of Russia. The number of participants of researches exceeded 300 people, 196 of which patients with the 5th stage of a chronic disease of kidneys made.  

According to information for April, 2019 in Russia 45 890 of patients on dialysis, 3,600 patients on a peritonealnomdializa and 8 thousand with a kidney transplant. The number of patients with this nosology steadily grows for 10-12% a year.B 2016 experts of the All-Russia People's Front and Zdorovye Fund a zafiksirovalisnizheniye of availability dialysis to a pomoshchinaseleniye. According to data of monitoring, in a year the number of procedures of a hemodialysis in Russia was reduced by 2 million. In 2017 from 40 thousand patients to whom replacement kidney therapy was applied only 80%, i.e. about 32 thousand patients, were on a hemodialysis. According to the experts, security with a hemodialysis in Russia is three times less, than in Europe.