Biocad Efleyra (Netakimab)

Efleyra (Netakimab) — medicine for treatment of blyashechny psoriasis of medium-weight and heavy degree. Represents the high-humanized monoclonal antibody developed by Biocad company original, IL-17 inhibitor. Medicine is registered in the territory of the Russian Federation.

2020

Approval of application for treatment of patients with psoriatichesky arthritis

On March 26, 2020 Biocad reported that regulators of the Russian Federation approved use of medicine netakimab for treatment of patients with psoriatichesky arthritis. Netakimab became the first original Russian medicine on the basis of monoclonal antibodies against SILT-17 for therapy of medium-weight and heavy vulgar psoriasis, the ankiloziruyushchy spondilit and now psoriatichesky arthritis.

At the heart of a molecule of a netakimab immunoglobulin of a lama, the closest to immunoglobulins of the person contains that promotes achievement of the fast, expressed and steady effect of therapy.

According to Biocad, received during clinical trials of medicine, 82.5% of patients with psoriatichesky arthritis reach the answer of ACR20 from peripheral joints, and 83% – the answer of PASI75 from skin manifestations by 24th week of therapy netakimaby.

At a half of the patients with a disease "psoriatichesky arthritis" participating in a medicine research improvement of a status of joints and skin manifestations on the second week of therapy was noted. And after 4 months of therapy at 39.2% of patients the disease reached the minimum activity.

Expansion of a scope of a netakimab will allow to increase several times a circle of patients who will receive modern therapy. The cost of a course of treatment domestic medicine is approximately three times lower, than when using foreign analogs, is sure the deputy CEO for marketing and sales of BIOCAD Oleg Pavlovsky

The representative of the company reported that according to the State Register of Medicines of the Ministry of Health of the Russian Federation, the marginal selling price of medicine for March, 2020 is 20,000 rub.

For March, 2020 nonsteroid anti-inflammatory medicines and basic anti-inflammatory medicines are most often applied to treatment of psoriatichesky arthritis. Patients with psoriatichesky arthritis receive therapy by biological medicines much less often in comparison with other rheumatologic statuses: rheumatoid arthritis and ankiloziruyushchiya spondilit. In many respects this results from the fact that psoriatichesky arthritis lies on a joint of two specialties – dermatology and rheumatology.

Also, in connection with the high cost of treatment biological therapy is received most often by patients with the set disability. Thanks to emergence of genetically engineered biological medicine of the Russian production, doctors will have an opportunity to provide with necessary therapy of patients at an early stage of a disease: not allow an invalidization of patients at early age or at all to influence process of a disease (for example, at patients with the psoriasis burdened by psoriatichesky arthritis).

Registration in the Russian Federation for treatment of a disease of Bekhterev

On January 30, 2020 it became known that the Ministry of Health of the Russian Federation approved registration of the Russian medicine with MNN (international non-proprietary name) netakimab according to the additional indication – ankiloziruyushchiya spondilit (Bekhterev's disease). Originally the first Russian original medicine on the basis of monoclonal antibodies against SILT-17 of biotechnology company BIOCAD was registered for treatment of medium-weight and heavy degree of psoriasis.

As it was reported, netakimab, having a favorable profile of security and efficiency at treatment of medium-weight and heavy psoriasis, since 2020 it will be available to appointment to adult patients with the diagnosis "ankiloziruyushchiya spondilit" at the insufficient response to standard therapy.

At the heart of a molecule of a netakimab immunoglobulin of a lama, the closest to immunoglobulins of the person contains that allowed to provide low immunogenicity of medicine and long effect of therapy (according to the clinical trials conducted BIOCAD companies, 80% of patients with an ankiloziruyushchy spondilit reach the answer by ASAS40 index in a year of therapy). Physical and chemical characteristics of medicine promote its good tolerance.

Results of the international multicenter randomized double blind placebo - controlled clinical trial of the III phase BCD-085-5/ASTERA confirmed efficiency and security of medicine at patients with an active ankiloziruyushchy spondilit. Participants of a research of steel of 228 patients with the ankiloziruyushchy spondilit saving the activity despite acceptance of standard treatment at least a month before screening inspection. Application of a netakimab in a dose of 120 mg resulted in the expressed therapeutic effect: clinically significant improvement was observed already at the first assessment on the 4th week of therapy; in 16 weeks of therapy decrease in expressiveness of the osteit according to MRT both in a backbone, and in a sacral podvzdoshnykh joints was noted. Therapy netakimaby was well transferred by patients, the frequency of the undesirable phenomena did not differ from the group accepting placebo.

The marketing vice president and to sales of BIOCAD Oleg Pavlovsky emphasized that expansion of a scope of medicine promotes increase in number of patients who will be able shortly to get access to hi-tech therapy.

Among genetically engineered medicines the tumor necrosis factor inhibitors an alpha rendering mainly anti-inflammatory effect are most often applied to treatment of patients with an ankiloziruyushchy spondilit for January, 2020. This class of medicines – interleukin-17 inhibitors which treats netakimab – except reduction of inflammation are capable to suppress the excess growth of a bone tissue, thus, interfering with progressing of a disease and an invalidization of patients.

According to price analysis on the biological medicines HWC for 2019 the annual course of therapy by medicine netakimab will be 25% lower than the average annual value of therapy of the ankiloziruyushchy spondilit medicines of a class of inhibitors of a factor of a necrosis of a tumor an alpha. Marginal selling price of medicine netakimab according to the State Register of Medicines of the Ministry of Health of the Russian Federation is 20,000 rub incl. the VAT.

Ankiloziruyushchy spondilit – the chronic inflammatory disease which is characterized by defeat sacral podvzdoshnykh joints and a backbone. According to the research published in the Revmatologiya magazine (volume 53, edition 4, April, 2014), prevalence of a disease in the world – about 1%. According to the Ministry of Health of the Russian Federation in Russia "Ankiloziruyushchy spondilit the diagnosis" is delivered only to 118,000 patients. The peak of incidence is the share of age from 25 to 35 years; functional violations develop in the first 10 years of a disease. About 40,000 patients, security with them for January, 2020 – less than 10% need genetically engineered biological medicines.

2019

Plans of an output of medicines netakimab and prolgolimab on the European market

On November 7, 2019 the biotechnology company BIOCAD provided netakimab and prolgolimab, original medicines on the basis of monoclonal antibodies. By also Russian producer it was announced plans of data output of medicines for the European market.

In Russia Netakimab "psoriasis" in April, 2019 was registered under the trade name Efleyra according to the indication, and in July it was approved by the commission Ministry of Health RUSSIAN FEDERATION for inclusion in the VED list. Investments into the project made 568 million rubles. Registration of immunooncological medicine prolgolimab is expected in the first quarter 2020, investments into the project exceeded 737 million rubles.

The company got permission to carrying out the international multicenter randomized double blind placebo - controlled clinical trial of a prolgolimab according to the indication "non-small cell cancer of a lung" in the territory of Slovakia and Hungary. In a research it is going to include at least 292 patients who will be taken during 12 months in the territory of the European Union, the Russian Federation, and People's Republic of China. At this stage the company is going to invest in the clinical trial necessary for a medicine output to the markets of China and the European Union countries, more than 25 million euros.

Obtaining permission to performing clinical trials of a netakimab in Europe is expected in 2020.

We did a long way that the first two domestic medicines on the basis of monoclonal antibodies could undergo clinical trials in the territory of the European Union and China. It is this break not only for our company, but also all Russian pharmaceutical industry. It is sure that medicines will take the worthy place in an arsenal of doctors worldwide, commented the marketing vice president of BIOCAD Oleg Pavlovsky

Demonstration of high efficiency in therapy of a disease of Bekhterev

On June 14, 2019 in Madrid results of clinical trial of the 3rd phase of the domestic medicine "netakimab" developed by Biocad company were provided. Results the leading specialist of Russia in the field of rheumatology, the doctor of medical sciences, professor, the associate professor of therapy and rheumatology of E.E. Eykhvald presented, SZGMU of I.I. Mechnikova Inna Gaydukova who took part in clinical trial as the researcher.

Netakimab — the original monoclonal antibody developed by the Russian company Biocad is applied to treatment of psoriasis and rheumatic diseases. The research was conducted in the territory of Russia and Belarus for the purpose of confirmation of therapeutic efficiency, assessment of security, pharmacokinetics and immunogenicity of a netakimab at patients with the active ankiloziruyushchy spondilit (AS).

228 adult patients with the set diagnosis "ankiloziruyushchiya participated in a research spondilit", saving activity of a disease, despite the previous therapy by anti-inflammatory medicines in a stable dose.

Results of the first 16 weeks of a research, according to Biocad company, confirm high efficiency of a netakimab at patients of AS (the share of the patients who reached affirmative answer on the 16th week (ASAS40) made 40.53% when using a netakimab and only 2.63% when using placebo) and allow to consider that the research achieved the goal.

Superiority over placebo is proved including data of MRT. Influence of medicine on blocking of bone inflammation and also efficiency of medicine in prevention of the structural progressing of a disease which is one of the invalidization reasons at AS is revealed. The insignificant number of the undesirable phenomena which was registered when using a netakimab, testifies to the favorable profile of its security not different from other representatives of a class of SILT-17 inhibitors.

The clinical trial provided in Madrid is registration, its data will form a basis for registration of medicine in the Russian Federation. This year clinical trial of medicine will be continued in the countries of the European Union and in China for registration of a netakimab according to the indication "axial spondiloartrit". Registration in Russia according to the indication "ankiloziruyushchiya spondilit" it is expected in the fall of 2019.

On development and clinical trials of a netakimab 7 years were required, investments into development made 685 million rubles. The innovation medicine according to the indication "psoriasis" will come to the Russian drugstores in June, according to the indication "spondilit" in November, 2019, to Europe — in the 2023rd, reported in Biocad.

Registration in the Russian Federation according to the indication "psoriasis"

On April 4, 2019 netakimab "psoriasis" was registered in Russia according to the indication.