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Biocad Biocad

Company

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Biocad is a Russian biotechnology company.

Owners:
Dmitry Valentinovich Morozov

Content

Revenue and Net Profit millions Ths. rub

Number of employees
2018 year
2200

Owners

BIOCAD

BIOCAD is an international innovative biotechnology company that unites a world-class research center, modern pharmaceutical production, preclinical and clinical research.


BIOCAD creates fundamentally new opportunities to treat diseases and improve the quality of life of patients. The development of original and reproduced medicines is carried out in the company's own research centers. All products are manufactured strictly according to international GMP standards. BIOCAD produces medicines and substances in the following areas: gynecology/urology, oncology and onco/hematology, autoimmune and infectious diseases. The total number of personnel includes more than 700 people, about 150 of whom are research laboratory researchers. BIOCAD has a wide network of subsidiaries abroad: in,,,, and Belarus To Ukraine. Brazil China India USA

Production of biotechnological company BIOCAD, Neudorf, SEZ "St. Petersburg"

Performance indicators

2020: Revenue - 33.3 billion rubles. (+ 38%), profit - 12.2 billion rubles. (+ 70%)

On August 13, 2021, information appeared that in Russia the profit of the pharmaceutical company Biocad, which produces the Sputnik V vaccine, increased by 70% over the year - from 7.2 billion rubles in 2019 to 12.2 billion rubles in 2020.

The company's revenue for the year also increased to 33.3 billion rubles (an increase of 38%), follows from the study of the API project "Contour. Focus."[1]

Information Technology in Biocad

2020: Most employees transferred to remote work due to coronavirus

On March 18, 2020, Biocad announced that most of its employees are moving to remote work in the home office. The "quarantine" mode for employees at home-office will last at least 30 days. Only research laboratories and production sites will continue to operate in the same format.

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Having analyzed the situation, as well as a three-stage action plan "to prevent the import and spread" of coronavirus infection in the country, we decided to motivate employees to switch to a remote mode of operation. There are several reasons for this, including a strong desire to keep your team healthy and able-bodied during a pandemic. In addition, realizing that social self-isolation can reduce the viral load on the city, we want to be active participants in these events. I myself decided to withstand the prescribed quarantine after meeting with Italian partners, after which I felt unwell and symptoms of ARVI,
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The head of the company added that the salaries of employees who chose remote work will remain in full, if necessary, the company will be able to allocate a laptop and other divides necessary for work.

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A special working group has been created in the HR department, which will prepare everything necessary to transfer company employees to remote work. The task of the group is also to develop measures that will allow the company's employees to stay healthy and ensure uninterrupted work,
counts Dmitry Morozov
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BIOCAD has developed a number of measures to reduce the epidemiological threat to employees, including regular communication about the disease and the impact of the virus on public life. To do this, a special hashtag# ask-coronavirus was introduced in the corporate communications system, according to which employees will be able to track quarantine-related news. In addition, the company canceled all events, limited the entry of visitors to the company and strengthened measures to clean and disinfect the premises.

As of March 18, 2020, a three-stage corporate program was developed to counter the spread of the virus at the enterprise and in the country. Measures of the first phase of the epidemiological threat are being implemented.

2019: Hybrid Cloud: Reality or Concept

From the presentation of Palnikov Pavel Director of the Department of Infrastructure Solutions, September 17, 2019.

Use on-premium as a replacement?

  • There is no apparent reason for this. There are resources of their own.

  • Use public cloud for DR as a service?
  • There is its own geographically distributed infrastructure.
  • But placing enterprise worldwide services in the cloud requires failover or HA on-premium.


BIOCAD cases:

  • SaaS - of course we purchase some services under this model, we are a large MS client in the Russian Federation as part of the Office 365 product.
  • PaaS - deploying microservices to the public cloud. Kubernetes
  • IaaS on demand - Use public clouds to expand infrastructure on demand.
  • This requires transparent migration of virtual machines, microservices to the public cloud and back on-premium.
  • Use as QA medium.
  • Additional SaaS services provided by the cloud (for example, in Azure: AD, MFA, Monitoring)

Technology Stack

  • On-premium infrastructure:
  • OpenStack. KVM + Ceph - for Biocad it is archaism, it has been used for several years, but it was decided to develop the infrastructure on it, because it requires a lot of resources for maintenance/updating and does not participate in the hybrid cloud in any way, although it has all the capabilities for this. SCOM - came to replace OpenStack as a possible solution to the poor performance of Windows guest systems in the KVM hypervisor and S2D as an alternative to Ceph for SDS.
  • SCVMM. Hyper-V + S2D
  • Kubernetes + Ceph All new enterprise services are developed using the microservice architecture model. Also, some of the existing Corp. Services are transferred to this architecture.

Public Cloud:

  • The integration of the Exchange cluster with Office 365 increased the depth of e-mail storage and increased service performance.
  • The integration of local Active Directory and Keycloack with Azure AD made it possible to implement single sign on and multifactor authentication in corporate services, including its own development.
  • Integration with Azure AD, as well as agents on On-prem servers, enabled the powerful Advanced Threat Protection tool
  • Unfortunately, the described solution leads to a vendor-lock on a specific cloud provider. The task of changing it, maximally preserving functionality, will require significant financial investments and changes in the local infrastructure.
  • At the same time, the possibility of preventing the use of a public cloud without direct losses for the Company has been preserved.

  • Work is underway to build a federation of Kubernetes clusters.
  • An obvious plus is that you can choose where to execute the application drop and with the CI/CD configured, everything will happen automatically.
  • An excellent solution for stateless services and providing them with DR.
  • However, for stateful services, you will have to look for a solution for storage replication.

Kubernetes Federation:

  • Lack of Federation support in the cloud services market in the Russian Federation.
  • If you have stateful services, you need a storage replication solution.
  • The development of the on-premium solution lags significantly behind the GCP
  • Some systems have been successfully converted to microservice architecture
  • Federation is supported by a limited number of cloud providers: GCP and AWS.
  • Basically, an alternative option is offered: a service based on the IaaS model, where your own cluster will be raised K8s
  • But GCP itself, for obvious reasons, primarily develops Kubernetes within the GKE.

  • The hybrid cloud, in its design, looks like a flexible solution, but does not have this flexibility when we decide to change the cloud service provider.
  • When choosing a provider, we are also limited by the compatibility of the local infrastructure and the provider infrastructure.

  • In the Russian Federation, there are practically no services for software developers or cloud services for information security specialists.
  • For this, foreign providers are used, but geographical remoteness affects the availability of services and introduces geopolitical risks.

But even when using services from the main market players, there are those where "hybridity" is absent as such and when you use it, you "get hooked" on this provider. For example, they found themselves with this when using the pipeline CI/CD of one of the largest providers of such a service, where they discovered the impossibility of using their own resources for assembly (build).

  • On the one hand, there is clearly a tendency to unify the architecture of private and public clouds. Subject to the transition to microservices.
  • On the other hand, several of the largest international cloud service providers are able to influence the future prospects of hybrid clouds.

2017: Interview with TAdviser of Evgeny Pochkayev, Vice President for IT Biocad

Evgeny Pochkaev, Vice President for Information Technology and Operational Development of the pharmaceutical manufacturer Biocad, told TAdviser in an interview in November 2017 why the company is focused on moving away from Western IT solutions towards its own developments, why it abandoned outsourcing computing resources and what are the advantages of the transition from "monster systems" to a microservice IT structure. Read the interview here.

History

2022

2-fold increase in the number of studies performed in 2 years

Biotechnological company BIOCAD on November 25, 2022 announced that it continues to increase the number of clinical trials of drugs for the therapy of cancer, autoimmune and orphan diseases. Since 2020, the company has doubled the number of research conducted.

As of November 2022, BIOCAD is conducting 37 clinical studies of drugs for the treatment of socially significant diseases, including melanoma, non-small cell lung cancer, neuroblastoma, cervical cancer, axial spondyloarthritis, multiple sclerosis and others. The company's clinical trials are taking place in Russia, the Republic of Belarus, China and Europe.

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BIOCAD not only continues to implement active clinical trials, but also plans to start trials of new drugs, opening up the opportunity for patients in Russia and abroad to gain early access to innovative therapies. In 2022, more than 2,400 people became participants in our research. In 2023, we expect more than 3,500 healthy volunteers and patients to take part in the company's clinical trials, "said Yulia Linkova, vice president for clinical development and research at BIOCAD.
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As of November 2022, the company's clinical studies are actively recruiting participants with axial spondyloarthritis, melanoma and neuroblastoma. In addition, BIOCAD is preparing to open the recruitment of participants in the study of a gene therapy drug for the therapy of spinal muscular atrophy, as well as in the clinical trials of the drug for the treatment of systemic scleroderma and Devik's disease.

In addition to researching new drugs, the company continues two international studies of the original drug prolgolimab, registered in Russia and the Republic of Belarus for the treatment of unresectable or metastatic melanoma. DOMAJOR in indication of non-small cell lung cancer (NSCLC) and FERMATA in indication of cervical cancer (cervical cancer). Clinical studies of the drug are underway in both Russia and China, and the DOMAJOR study also includes participants from the European Union.

Opening of a warehouse for medicines at Alabushevo site

A warehouse for medicines has begun work at the Alabushevo site of the Moskva technopolis. This was announced on October 27, 2022 by the Department of Investment and Industrial Policy of the city of Moscow (DIiPP).

The warehouse complex was launched on the territory of the pharmaceutical complex "PK-137" of the biotechnological company "Biocad" - a resident of the special economic zone of Moscow.

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A resident of the SEZ "Technopolice Moscow" built a high-temperature warehouse complex with an area of ​ ​ four thousand square meters at the Alabushevo site. It is designed to store all types of raw materials and packaging that are used in pharmaceutical production. The storage capacity makes it possible to ensure one-time storage of up to 10 thousand paleto-places, - said Vladislav Ovchinsky, head of the Department of Investment and Industrial Policy of the city of Moscow (DIiPP).
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The premises of the complex are equipped with high-moisture equipment and specialized narrow-passage equipment. Thanks to this, it is possible to store and process cargo at an altitude of up to 19 meters. Special temperature conditions have been created for the storage of raw materials and packaging. Thus, a main storage area (+ 15-25 ° C), a refrigeration chamber (+ 2-8 ° C) and a controlled humidity chamber (40-60%) are provided. In addition, there are separate rooms for storing flammable materials. The warehouse is also equipped with refrigeration rooms for unloading, processing and shipping drugs, for the safety of which it is necessary to maintain the temperature within the "cold chain."

The production complex "PK-137" was created to implement the offset contract concluded between the city and the company "Biocad." According to its conditions, the plant produces drugs for the therapy of oncological and autoimmune diseases. The total volume of shipments of drugs for 2021 to medical institutions in Moscow amounted to about 290 thousand packages. For two quarters of 2022 - more than 250 thousand packages.

To ensure the production of medicinal products, the company has created a quality control system that meets GMP standards (a system of standards, a set of rules and guidelines that contribute to ensuring a high-quality production process, including storage and testing of products). The complex of buildings "PK-137" is equipped with high-tech production equipment, advanced engineering solutions are used that increase the investment and operational efficiency of the facility. In addition to the production site, there are chemical and analytical and microbiological laboratories at the site.

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The total area of ​ ​ the pharmaceutical complex at the Alabushevo site is 43 thousand square meters. The company invested over 5 billion rubles in the implementation of its project, which made it possible to create more than 170 new jobs, "said Gennady Degtev, General Director of the Moscow Technopolice SEZ.
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Refusal to build a plant in Finland

On September 12, 2022, it became known that Biocad refused to build a plant in Finland 5 years after the conclusion of the agreement. The Russian pharmaceutical company was going to implement a project in Turku.

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In a difficult geopolitical situation, as well as taking into account unfavorable conditions for business development in Finland, it was decided to close the plant construction project, allocating resources to meet the needs of Russian patients, the Biocad press service said.
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The main task for Biocad was to provide the Russian health care system with the necessary drugs, representatives of the company noted.

Biocad Company

Biocad signed an agreement on the construction of a Russian pharmaceutical plant in Finland in 2017 with the Turku Science Park pharmaceutical cluster, the University of Turku and the Abo Academy. It was planned to invest 25 million euros in it. A building permit was obtained in 2019, but it was never started due to regulatory difficulties. Due to this project, the company wanted to be able to implement research projects in the field of immuno-oncology together with European colleagues.

However, the company, whose headquarters are located in St. Petersburg, has many interesting projects in Russia. First of all, they are associated with the development and introduction into circulation of new original drugs, from such severe diseases as neuroblastoma (brain tumor), melanoma (skin cancer), multiple sclerosis, spinal muscular atrophy (SMA), etc. Also, "Biocad" has created its own original vaccine against coronavirus, which is now being tested.[2]

Agreement on strategic cooperation with the Ministry of Health of Belarus

On March 29, 2022, BIOCAD announced that a document on strategic cooperation with the Ministry of Health of Belarus had been signed. The parties plan to direct the effort to uninterrupted provision of citizens of both countries with therapy for complex and serious diseases.

Biocad signed a strategic cooperation agreement with the Ministry of Health of Belarus

According to the company, the main goal of the signed agreement was to ensure quick and sustainable access for patients to innovative approaches in the therapy of socially significant diseases, as well as to promote the development of an effective and sustainable health protection system for citizens of Belarus. On the part of the company, the document was signed by the general director of BIOCAD Dmitry Sivokoz, on the part of the republic - by the Minister of Health of Belarus Dmitry Pinevich.

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Both in Russia and in Belarus, special attention has always been paid to the health of citizens, in particular, to ensuring effective therapy for the prevention and treatment of severe and deadly diseases. The fact that we are joining forces to achieve humanitarian and social goals.

commented on the signing of the agreement Dmitry Sivokoz
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According to the Director General of BIOCAD, the signed agreement will increase the availability of vital drugs for Belarusian patients by optimizing logistics and financial chains. In addition, the agreement provides for the exchange of experience in the therapy of chronic and oncological diseases, and most importantly, the foundation for long-term partnerships between countries is laid. BIOCAD considers the EAEU and CIS countries, and especially Belarus, as important strategic growth points for development. The first step will be to expand the company's presence: opening branches with official representatives and launching educational programs for health care professionals.

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The agreement between the Ministry of Health of Belarus and BIOCAD will ensure patients' access to innovative approaches in the therapy of socially significant diseases. The agreements will make it possible to introduce flexible pricing models, as well as prepare a platform for discussing the potential localization of a number of BIOCAD drugs at the production sites of Belarusian manufacturers. We also plan to start training Belarusian medical and pharmaceutical workers based on the integration of the scientific, educational, innovative and technological potential of the Republic of Belarus and BIOCAD.

noted Dmitry Pinevich, Minister of Health
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According to analytical to data IQVIA, the market of the Republic of Belarus has grown steadily over the past few years, and has accelerated significantly over the past 2 years. In 2021, the drug market of the republic showed positive dynamics by 19% and amounted to 111.1 billion, Russian rubles while the share of the retail market reached 71.6%, the share of the hospital market - 27.8%, the share of the non-medical segment - 0.6%. The growth driver is the hospital segment, the growth of which in 2021 amounted to 53%.

As of March 2022, BIOCAD conducts 20 clinical trials of drugs at various stages in Russia, Belarus, China and Europe. Patients with axSpA, non-small cell lung cancer, cervical cancer, psoriatic arthritis, multiple sclerosis, melanoma, paroxysmal nocturnal hemoglobinuria, and healthy volunteers are either on study therapy or on follow-up as part of ongoing studies.

On March 30, 2022, the Belarusian delegation is expected to visit the company's production complex in the village of Strelna. Representatives of Belarus plan to inspect the production facilities of the enterprise and get acquainted with the scientific.

Transfer of Dmitry Morozov to the position of Chairman of the Board of Directors

Dmitry Morozov moved to the position of Chairman of the Board of Directors of BIOCAD. The company announced this on March 4, 2022. Read more here.

2021: Establishing a data analysis school to train specialists in conjunction with SAS

BIOCAD and SAS have established a data analysis school to train specialists. BIOCAD announced this on November 22, 2021.

The training started on October 18, 2021. The program for training SAS programmers is designed for 5 months.

Pharmaceutical companies engaged in clinical research are dealing with large amounts of data required to obtain regulatory approvals. There is a lack of qualified employees in the labor market who know how to competently work with these data and draw them up in the form of a dossier, which will be submitted to the relevant authorities in the future.

Experts of the SAS Training Center, together with Anton Meshcheryakov, Head of Biostatistics and Data Management at BIOCAD, have developed a specialized course for a period of two weeks, which is the starting block of the program. Students of the program will receive in-depth knowledge of programming in the SAS Base, SAS Macro language, study the necessary statistical methods, as well as the specialized tools that are required to create a dossier.

{{quote 'This is not the first experience in preparing specialized training for BIOCAD. Over the years of cooperation, specialists from the Clinical Development Department have set us non-standard and very interesting tasks, "said Lyudmila Lokteva, head of the SAS Training Center. }}

The program of the SAS school BIOCAD is designed for novice specialists with programming experience in any language. 270 people applied for training. Of these, 10 people were selected and began training on October 19. A mandatory element of the program is the passing of an international certification exam, confirming a high level of knowledge and practical skills, since the exam includes directly the creation of programs. For November 2021, everyone who began training on October 19 has already successfully passed the exam.

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Our company is rapidly developing, and as of November 2021, we have about 30 parallel clinical research projects in operation. At least two programmers are needed to analyze the data of each of them. That is why we have high hopes for the BIOCAD SAS school. We expect an influx of competent specialists who can meet the requirements of the pharmaceutical industry. For clinical trials within a strict regulatory framework, SAS is an industry standard and our long-standing partner, so it was the experts who were chosen as co-authors of the training program, SAS said Yulia Linkova, Ph.D., Director of the Clinical Development Department, BIOCAD.
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After summing up the results of the training of the first set of SAS schools, BIOCAD will decide on the re-launch of the set and on the possible annual implementation of the project.

2020

Mikhail Mishustin's visit to production in Strelna

Russian Prime Minister Mikhail Mishustin arrived on a working visit at the BIOCAD production complex of the St. Petersburg Special Economic Zone in the village of Strelna, where he held a working meeting and checked the release of the Sputnik-V vaccine. The meeting was attended by members of the Government of the Russian Federation. At the Biocad site, 863,285 doses of vaccine (I + II component) have already been produced and delivered to the warehouse. The company announced this on December 25, 2020.

Photo: RIA Novosti, Author: Dmitry Astakhov
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The government is taking all necessary measures to develop Russian vaccine companies. I can absolutely say that such support will continue, especially when the need for domestically produced drugs is so great, "the head of government said during an inspection of the company's research and production center, where he got acquainted with the production of the Sputnik V coronavirus vaccine.
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The head of government first visits the production complex of BIOCAD, which has become one of the key manufacturers of the first Russian vaccine in Russia. The production building in Strelna includes areas of biotechnological substances, clinical batches, filling and packaging, characterization and scaling, freezing of substances and cell banks. The total area of ​ ​ the PC buildings is 27,560 m2, of which the production part is 13,626 m2, the warehouse part and the logistics center are 1,934 m2.

Completion of the construction of pharmaceutical production in the special economic zone "Technopolice Moscow"

On September 9, 2020, BIOCAD announced the completion of constructions pharmaceutical production in the special economic zone "" Technopolice Moscow(Alabushevo site in the city of,) under To Moscow Zelenograd the first offset contract c. Government of Moscow More. here

Biocad

2019

Permit to conduct a clinical trial in Slovakia

On September 27, 2019, biotech company BIOCAD announced that it had received permission to conduct clinical study of an original drug of own development in one from European Union countries. The company will be able to conduct a clinical in Slovakia DOMAJOR study of prolgolimab INN for treatment non-small cell lung cancer. At this stage, the company plans to invest in clinical trial necessary to bring the drug to the markets of China and countries European Union, more than 25 million euros.

Bratislava Slovakia

  Approval to conduct a clinical trial (CI) in Slovakia was the first to territory of the European Union.

{{quote 'author = commented on the event Roman Ivanov, Vice President of BIOCAD for Development and research 'This is only a small Slovakia so far, but we have received confirmation to the fact that huge work on the development of the drug in accordance with the ICH recommendations was not in vain. I am sure holding permits will follow soon CI of this Russian drug in other EU countries }}

This clinical trial is an international multicenter randomized, double-blind, placebo-controlled, comparative clinical a phase III, parallel-group study that aims to study efficacy and safety of the combination of BCD-100, pemetrexed and cisplatin/carboplatin versus a combination of placebo and pemetrexed; cisplatin/carboplatin as first-line therapy for patients with metastatic non-small cell non-squamous lung cancer (NSCLC). The study is based on the hypothesis that the use of the drug BCD-100 in combination with chemotherapy contributes to increased overall survival compared to chemotherapy in combination with placebo.

It is planned to include at least 292 patients in the study, who will be recruited in period of 12 months on the territory of the European Union, the Russian Federation, and the Chinese People's Republic. The next European Union country to be ready is predicted issue a permit to conduct the CT, it will become. Hungary It is expected that this will happen already in October 2019.

Final agreement with Shanghai Pharmaceuticals Holding to establish JV

On September 18, 2019, Biocad announced TAdviser that during the twenty-fourth regular meeting of the heads of government, Prime Minister Russia Dmitry Medvedev and Premier of the State Council Li People's Republic of China Keqiang witnessed the signing of a final agreement between Biocard Shanghai Pharmaceuticals Holding and the creation of a joint venture with the aim of bringing Russian-made drugs to the market.

Russian Prime Minister Dmitry Medvedev and Biocad Director Dmitry Morozov

Biocad was represented at the signing by the founder and CEO of the company Dmitry Morozov, on the part of the Chinese company, the agreement was signed by the chairman of the board of Shanghai Pharmaceuticals Holding, Mr. Jun Zhou. The joint venture will have a capital of US $400 million. Biocad will grant SPH permanent and exclusive rights in Greater China (including mainland China, Hong Kong, Macau, and Taiwan) to develop, manufacture, and commercialize six proprietary biopharmaceutical products: inn - bevacizumab, trastazumab, adalimumab, original netakimab, and prolgolimab, and one original drug in preclinical studies.

Chairman of the Board of Shanghai Pharmaceuticals Holding Mr. June Zhou and Director of Biocad Dmitry Morozov
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As of September 2019, this is the largest international deal for Biocad. For years, we have been looking for the right partner in, and we are China absolutely confident that we have found him. Registration procedures often take a certain amount of time. Much, of course, will depend on the regulator from China, but approximately, according to our forecasts, for the first three to four years the joint venture will mainly deal with clinical trials and registration of six Biocad products in China. Three of them are monoclonal antibody-based biosimilars for therapy oncological and autoimmune diseases. Four of these six drugs are being successfully implemented Russia in other countries as well. One original immuno-oncology drug for September 2019 is undergoing phase III trials internationally. And another - a promising original product - is at the preclinical stage. The joint venture offers great prospects for Biocad - first of all, access to the Chinese to pharmaceutical market, as well as SPH's many years of local experience in sales and promotion,
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Shanghai Pharmaceuticals President Man Cho called the collaboration with Biocad a big step for the company to develop in the field of biopharmaceuticals, and also expressed a desire to continue cooperation:

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The six drugs selected within the framework of cooperation demonstrate wide opportunities in the field of science and innovation and have great marketing potential in the cooperation region. This transaction, we hope, will begin a long-term cooperation with the subsequent diversification and optimization of the line of drugs to maximize the provision of patients.
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June Zhou, Chairman of Shanghai Pharmaceuticals, stressed that the deal with Biocad is an important stage in SPH's innovative transformation and international development, which demonstrates the company's strategic determination to use a multi-vector approach to provide leap-forward development and leadership in innovation. Against the background of strengthening and comprehensive development of Russian-Chinese relations, this project, as the first cooperation between Shanghai Pharmaceuticals Holding and a Russian company, will actively develop with the support of two governments that share the concept of "operation, innovation, mutual benefit and mutually beneficial results."

The peculiarity of the deal is that the joint venture can use its resources to conduct clinical trials in late stages not only in China, but also in the EU, thus providing the best clinical data to doctors and regulatory authorities. As China relaxes some of its strict registration rules for biologics produced outside the country, the parties to the agreement hope to significantly increase access for patients in China to drugs for cancer and autoimmune diseases.

The 6th Biocad production complex will be launched in the SEZ "St. Petersburg"

As of September 2019, Biocad has 5 production sites. At the same time, in 2019, the production complex in the SEZ "St. Petersburg" (Strelna) with an investment volume of 3.2 billion rubles is launched. The automation system of this PC is also developed by the company.

Creation of joint venture with Shanghai Investment Holding (SPH) to enter the Chinese market

On June 5, 2019, in the presence of the leaders of the two countries - the President Russia Vladimir Putin and Chairman of the People's Republic of China - Xi Jinping a binding agreement was signed in the Kremlin between the shareholders of the new joint venture - BIOCAD and Shanghai Pharmaceuticals Holding (SPH). The new legal entity will receive the right to commercialize the development of a Russian manufacturer in the PRC. BIOCAD at the signing of the document was represented by the founder of the company and the CEO, on the Dmitry Morozov Chinese side, the agreement was signed by the chairman of the board of the Shanghai Investment Holding, Mr. Jun Zhou. It is expected that the total capitalization of the joint venture should be $2.8 billion.

The new enterprise is being created for clinical trials, registration and launch on the PRC market of at least 6 drugs based on monoclonal antibodies, including biosimilars and original drugs developed in BIOCAD for the treatment of cancer and severe autoimmune diseases (chronic lymphocytic leukemia, colorectal cancer, lung cancer, breast cancer, psoriasis, ankylosing spondylitis). BIOCAD is the first Russian biotechnology company to enter the international pharmaceutical market with original monoclonal antibody-based drugs.

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"We expect that today's agreement will be the foundation of the future trust of Chinese patients, pharmaceutical business and the Chinese government in the modern Russian biotechnology industry. In the future, partnership with SPH will give a vector to the development of cooperation between the two countries in the pharmaceutical field, "said Dmitry Morozov.
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The signed agreement between the parties is considered as the start of long-term cooperation, within the framework of which SPH and BIOCAD will be able to choose drugs with the highest potential demand in China from the developments of the Russian manufacturer. Investments in clinical trials of drugs are planned in the amount of $250 million.

The development of foreign economic activity is a key area of ​ ​ work of the biotechnological company BIOCAD. The amount of export contracts concluded over the past few years is approaching $1 billion, at this time the supply of high-tech medicines of their own production is carried out to 21 non-CIS countries.

Signing of a memorandum with the Ministry of Health of the Republic of Cuba

On May 27, 2019, biotech company BIOCAD announced that it had signed a memorandum of understanding with the Ministry of Health of the Republic of Cuba. To sign the document, a high-ranking official came to the Russian enterprise from Cuba.

The purpose of the document is to develop bilateral cooperation in the field of pharmaceuticals, biotechnology, science and the supply of Russian-made medicines to the island nation in Latin America. Deputy Minister of Health of the Republic Dr. Marcia Kobas Ruiz arrived to sign the document from Cuba. The Russian side was represented by the general director of BIOCAD Dmitry Morozov.

Deputy Minister of Health of the Republic Dr. Marcia Kobas Ruiz and Director General of BIOCAD Dmitry Morozov

According to the memorandum, the Russian manufacturer offered the Cuban side the supply of high-tech and safe drugs, three biosimilars used in the therapy of various types of cancer: bevacizumab, rituximab, trastuzumab, which will become drugs based on monoclonal antibodies of Russian production, supplied to the Republic of Cuba. The company estimates the Cuban market for three drugs at $15 million.

Cuba confirmed its readiness to assist the Russian side as much as possible in ensuring the access of BIOCAD drugs to the Cuban market, including the company in the list of suppliers of the import-export company MediCuba drugs and medical equipment.

Dmitry Morozov noted:

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Our country has traditionally developed strong and reliable partnerships with Cuban colleagues in the field of science, education, medicine and pharmaceuticals. The people of Cuba have always been fraternal for the Russian people. And of course, it is now important for us to join forces in the fight against such severe diseases as oncological and autoimmune nosologies.
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Marcia Kobas Ruiz added:

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We are glad that we can actively cooperate with the Russian company as part of the cancer program. This concerns both the prevention of diseases and joint efforts in conducting scientific research, organizing early diagnosis and increasing the effectiveness of treatment of severe diseases.
Marcia Cobas Ruiz, Deputy Minister of Health of the Republic Dr.
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Dmitry Morozov emphasized the high social and economic significance of the memorandum, both in terms of providing high-tech and high-quality anticancer therapy to Cuban patients, and in the context of the goals of the national program in the development of international cooperation and exports, including increasing the export of non-primary goods.

Market Launch of a Domestic Product for the Treatment of Renal Anemia

On April 1, 2019, the biotechnological company BIOCAD announced the receipt of a marketing authorization for the drug with INN darbepoetin alpha, a domestic biosimilar intended for the treatment of anemia in chronic renal failure. The company intends to occupy half of the market throughout the class of drugs during 2019. The drug will go on sale within the next 30 days. The volume of investments in development amounted to over 400 million rubles. Read more here.

2018

Partnership agreements with representatives of the pharmaceutical industry of Greece, the UAE and Mexico

Biotech company Biocad on October 15, 2018 announced the signing of partnership agreements with representatives, and pharmaceutical industries Greece UAE. Mexico A contract has been signed with the Greek company WinMedica for the supply of biosimilar adalimumab for the treatment of a number of autoimmune diseases, which will soon be approved Russia in and is preparing for registration in European Union 2021. Previously, in 2019, clinical trials will begin in European countries. Biocad plans to deliver more than 115 thousand packages to Greece and Cyprus during the first 5 years of sales.

At the same time, an agreement was signed with a large pharmaceutical manufacturer Julphar, operating in the Middle East, on the supply the Russian antineoplastic of drugs to the United Arab Emirates. With the Mexican company Psicofarma, S.A. De C.V. Biocad entered into a contract for the technological transfer of three drugs based on monoclonal antibodies: biosimilars trastuzumab, rituximab and bevazumab.

The company plans that by 2023 the total sales in the European Union will be at least $198 million, in the countries of Southeast Asia, Latin America and MENAT (Middle East, North Africa and Turkey) - $516 million. According to the company, in 2018, sales of Biocad outside Russia will grow by 80%.

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As of October 2018, the core of our exports is formed in Africa, India and Southeast Asia, - said Dmitry Morozov, CEO of the biotechnological company Biocad, - but after the imminent receipt of registration certificates in Latin America, including Argentina, Colombia, and MENAT countries, primarily in Egypt, leadership will go to these regions. We also expect high sales after the completion of registration procedures in the EU countries, in Japan and China.
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Since September 2017, the company has been actively working to localize Biocad production Finnish in Turku. In 2019, it is planned to complete the design of the plant, work on the organization of a network of external analysis laboratories, the start of clinical studies in the countries, European Union order materials and work on the construction of clean rooms in the plant building, and supply equipment and systems to the site. The first sales Finland in are scheduled for 2022.

Biocad supports the development of export potential Ministry of Industry and Trade Russia and. At Ministry of Economic Development the same time, a strict pharmacovigilance system of the Russian Federation in serves as a kind of guarantor of the safety and effectiveness of Biocad products when registering in international markets. According to Dmitry Morozov, for the development of the industry towards the development and promotion of innovative products to companies such as Biocad, "it is vital to enter international markets, because only global sales will be able to provide the level of resources necessary for the preclinical and clinical development of new generation medicines."

According to Biocad as of October 2018, the company has entered into contracts for the supply of drugs in the amount of over $850 million.

Launch of the master's program "Mathematical Biology" on the basis of MIPT

On September 1, 2018, at the Department of Innovative Pharmaceuticals, Medical Technology and Biotechnology of the Fiztech School of Biological and Medical Physics of the Moscow Institute of Physics and Technology, training starts at a master's program implemented jointly with the biotechnological company Biocad and focused on training specialists in the field of computational and mathematical biology.

As of August 9, 2018, the total enrollment is closed, but the interview with candidates who expressed a desire to transfer to the master's program continues.

Biocad launches master's program "Mathematical Biology" based on MIPT

According to Biocad, the two-year training will take place on a budgetary basis and will include an in-depth study of statistics, combinatorics, machine learning, programming, biochemistry, as well as molecular simulation methods. Experienced Biocad employees, teachers of the Fiztech School of Biological and Medical Physics of the Moscow Institute of Physics and Technology and the Fiztech School of Applied Mathematics and Computer Science will be involved as lecturers.

Existing bioinformatics programs mainly focus on genomic research. Unlike them, the joint master's program of MIPT and Biocad offers an emphasis on structural and systemic bioinformatics, the company explained. Undergraduates will learn to use the modern mathematical apparatus in the tasks of modeling biological systems, analyzing chemical reactions and creating original therapeutic molecules. Thus, both drug developers and all companies associated with the use of modern biotechnology can become potential employers of future masters.

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Within the framework of the Federal Target Program Pharma-2020, we have opened an industry competence center in the field of bioinformatics and are actively working on its development. An important task is to launch training in a master's program, which is developed in partnership with international biotechnology companies. Such cooperation will allow our graduates to acquire the necessary skills and industry competencies, which, I am sure, will become the foundation for the innovative development of the Russian pharmaceutical industry, - emphasized the result of the Victor Nazarov, director of the Fiztech School of Biological and Medical Physics of the Moscow Institute of Physics and Technology.
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Bioinformatics is actively used at the entire stage of drug development, Biocad said. Thanks to computational methods, the physicochemical properties of the future drug are determined at early stages, the environment for its production and the design of experiments is formed. At later stages, bioinformatics are accompanied by preclinical and clinical studies: their task is to select the optimal doses of the drug and its administration regimens to achieve the necessary therapeutic effect.

Completion of clinical trials of the first Russian drug for the treatment of renal anemia

The main method of treatment and prevention of renal anemia is drug therapy with drugs based on erythropoietin. The most effective drugs for 2018 are considered to be created on the basis of darbepoetin alpha, but so far Russian patients have been forced to use expensive drugs from foreign manufacturers. However, in 2018, BIOCAD announced the completion of clinical trials of the first domestic biosimilar darbepoetin alpha (BCD-066), which is intended for the therapy of anemia in renal and oncological diseases. The volume of investments in development amounted to 400 million rubles. The drug should go on sale at the end of 2018, and in 2021 the company intends to bring to the market its own innovative development of a new drug for the pharmaceutical market for the treatment of anemia in patients with renal failure.

As of July 2018, expensive imported darbepoetin alpha is purchased under government guarantee programs. In 2016, about 1 billion rubles were allocated from the budget for these purposes, in 2017 - more than 1.1 billion rubles. According to the public procurement portal, since the beginning of 2018, almost 200 million rubles have already been allocated from the state budget for the purchase of darbepoetin alpha. According to BIOCAD, the cost of biosimilar will be significantly lower than that of imported drugs, which will provide the necessary drug with a larger number of patients in need.

According to the company's estimates, in 2019 the sales of the new drug will amount to about 700 million rubles. At the first stage, the medicine will be sold only on the Russian market, but in the future BIOCAD expects to organize the export of its biosimilar to the countries of the Unified Customs Union. This, in turn, will increase sales of the drug to 3 billion rubles a year. BIOCAD expects to achieve this indicator in 5 years.

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"Today there is practically no competition in the darbepoetin alpha market. Given the stable growth and opportunities for income generation, the market is promising and open to new participants. BIOCAD's new biosimilar of darbepoetin alpha has received positive feedback from the professional community. And given the fact that our development is so far the only domestic long-acting drug for the therapy of renal anemia in the Russian and post-Soviet markets, we have every chance of taking a significant share of it. In the future, with the release of the original drug, BIOCAD plans to become a prominent player in the global market for drugs for renal diseases, "says Oleg Pavlovsky, vice president of marketing and sales at BIOCAD.
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Opening of the Master's Program "Bioengineering and Biomedicine" at SPCFU

On June 14, 2018, the biotech company Biocad announced the opening St. Petersburg Chemical and Pharmaceutical University Ministry of Health Russia of the master's program "Bioengineering and Biomedicine" on the basis of (SPCFU) under its patronage. The first recruitment will be 15 people.

Within the framework of the master's program, students will receive knowledge about modern biotechnological methods, about the features of the search and development of drugs based on monoclonal antibodies and about drugs for gene therapy, about the increasing role of computer science in the development process, high-performance modeling of molecules, big data analysis, hybrid technologies, automation and robotization and much more. According to Alexander Karabelsky, Director of the Biocad Advanced Research Department, who headed the master's program, training personnel for the pharmaceutical industry requires a deep understanding of the real problems of the process of creating innovative science-intensive drugs.

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Such knowledge comes only with practice, - explained Alexander Karabelsky. - Our program allows students not only to gain knowledge about the latest discoveries and current research in this field of knowledge, but also to be included in real research projects with the beginning of classes in September. In addition, Biocad itself urgently requires specialists of this profile. I confess that in the coming years we will need at least 10-15 bioengineers who know at the same time chemistry, biology, who are able to work both on high-precision and productive equipment within the framework of research projects, and on pilot-industrial production sites, who know at the same time management and relationships of biotechnologies.
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It is planned that students of the master's program "Bioengineering and Biomedicine" will practice, including at Biocad, will take part in specialized conferences, will be able not only to study, but also to work with leading industry specialists. The program involves targeted training of researchers and practitioners who are able to master and develop the latest technologies for the development and production of targeted highly effective biotechnological medicines of various nature.

The acceptance of documents was announced until July 10, the completion of the entrance tests conducted at the SPHFU of the Ministry of Health of Russia is scheduled for July 27.

$26 million for the infrastructure for the creation of gene-therapeutic drugs

On May 24, 2018, at the St. Petersburg International Economic Forum, with the participation of Deputy Minister of Health of the Russian Federation Sergei Krayevoy, agreements were signed on cooperation and implementation of joint research work between the V.A. Almazov National Medical Research Center and the biotechnological company BIOCAD on joint scientific research of adoptive immunotherapy (CAR T-cell therapy). The method of CAR T-cell therapy is based on the introduction of genetically modified own T-lymphocytes to the patient, providing recognition of tumor cells.

The agreements were signed by the head of the Federal Center named after V.A. Almazova Evgeny Shlyakhto and the general director of the biotechnological company BIOCAD Dmitry Morozov with the participation of the Deputy Minister of Health of the Russian Federation Sergei Krayevoy. The representative of the Ministry of Health of Russia stressed that the signing of an agreement on joint research between a state and commercial institution in the most advanced area of ​ ​ creating individual antitumor biomedical cell products will allow the country to make a breakthrough in the development and promotion of innovative methods of treating cancer, strengthen the competitiveness of the industry in the global market, as well as provide Russian cancer patients with modern and effective means of therapy. Such agreements, the deputy minister added, give confidence that the May decrees of the President of the Russian Federation will be implemented.

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Dmitry Morozov called the task fulfilled, since its solution is based on clear calculations: "We have all seen the success of our health care in reducing mortality from cardiological diseases, the next task is to provide a wide range of patients suffering from cancer with modern and effective therapy." According to Dmitry Morozov, the manufacture of individual drugs per patient will not exceed 16 million rubles, which is two times cheaper than in Western clinics. After that, for three years, he will not need additional therapy, only periodic monitoring by a doctor. Evgeny Shlyakhto pointed to the second aspect of the agreement with an innovative biotechnology company - to find new approaches to the education and training of Russian doctors so that they are guided in new areas of science, such as synthetic biology.
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The next stage of testing a domestic drug for patients with psoriasis

On April 13, 2018, the biotechnological company BIOCAD announced the completion by Russian scientists of a multicenter study of the first domestic original drug for the treatment of patients with severe psoriasis. The Russian development was supported by the Ministry of Health.

Thanks to the domestic drug, the cost of therapy for patients with severe psoriasis will be reduced by 25%

Registration of the drug is scheduled for the end of 2018, said Roman Ivanov, vice president of development and research at the biotechnology company BIOCAD. As he said, the action of the Russian drug based on monoclonal antibodies (international non-proprietary name - netakimab) is aimed at blocking the mediator of inflammation interleukin-17, which supports the development of autoimmune diseases.

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There is reason to believe that netakimab will be the best interleukin-17 inhibitor in the class. Another Phase 3 clinical trial will begin next year in the European Union. In it, we will compare our drug head-to-head with a foreign interleukin-17 inhibitor, which will finally demonstrate how true our expectations are. Netakimab is a rare example of a monoclonal antibody used to treat a chronic disease that has such a favorable safety profile, Roman Ivanov emphasized.
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According to him, the development of a domestic inhibitor was carried out by the company's researchers for six years. Thanks to the drug, the cost of therapy for patients with severe psoriasis will be reduced by 25%.

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The development of the domestic original drug was carried out in accordance with Russian legislation and the main international recommendations in the field of drug research based on monoclonal antibodies and required more than 500 million rubles of investment. According to our calculations, netakimab has strong export potential, and we plan that the drug will go on sale no later than the beginning of 2019, - added the vice president of the company.
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In general, the completed study showed that the use of netakimab throughout the year allows to maintain a significant improvement in the manifestations of psoriasis in 98% of cases, while more than 50% of patients by the end of the observation showed complete cleansing of the skin from psoriasis. According to the researchers' observations, the 120 mg dose is most effective: in the group receiving netakimab monthly in this dose for six months, all patients reached the PASI100 indicator, which corresponds to complete cleansing of the skin. The high efficacy of netakimab is combined with satisfactory safety: no serious toxicity has been reported, indicated in BIOCAD.

According to the company, the volume of the Russian market for targeted drugs, including those used for the therapy of psoriasis and ankylosing spondylitis, exceeds 6 billion rubles. The average annual cost of therapy for one patient with psoriasis or ankylosing spondylitis with foreign drugs ranges from 0.6 to 1.3 million rubles. It is planned that the first Russian IL-17 inhibitor (netakimab) will become more available compared to other drugs of this class. In the world, psoriasis affects about 4% of the population. The most vulnerable group are 22 to 35-year-olds. Most psoriasis patients have serious psychological problems associated with isolation from society.

2017

Leadership in public procurement of drugs in Russia - 4.2% share

According to the audit of the pharmaceutical market in Russia conducted by the analytical company IMS Health for January-December 2017, the biotechnological company BIOCAD for the second year in a row retained leadership in the budget procurement segment (information on all drugs was taken into account) in rubles in final prices, and also for the first time topped the rating of suppliers in the public procurement segment of anticancer drugs within the framework of the 7VZN program, and outside the program.

"For the
first time in the recent history of Russia, when a domestic company becomes the leader in sales of anticancer drugs in its country," comments Dmitry Morozov, CEO of BIOCAD, "previously our market belonged to foreign companies. Moreover, unlike our colleagues, we not only retained our position, but also increased the volume of supplies in natural quantities, providing the state with significant savings in calculating costs per unit. "

BIOCAD's share in public procurement of medicines in 2017 amounted to 4.2% with revenue of 15.66 billion rubles. The top three also included Novartis and Aventis with indicators of 3.5% and 3.2%, respectively. The list is closed by Generium JSC, the second Russian company to be among the ten largest pharmaceutical companies, suppliers of medicines to state medical institutions. In the segment of anticancer drugs, BIOCAD holds 14.2% excluding 7VZN and 18.9% including the program.

As part of public procurement, the total sales of drugs produced in the company based on monoclonal antibodies in natural quantities increased by more than 60%.

Victory over Roche's daughter in rituximab patent dispute

In December 2017, it became known that Biocad won a dispute with the American company Genentech (part of the Roche Holding group of pharmaceutical companies) to invalidate the patent for the use of drugs based on the active substance rituximab for the treatment of rheumatoid arthritis. The conclusion of the board based on the results of the consideration of the objection is published on the website of the Chamber for Patent Disputes.

"The collegium concluded  that there were grounds for Rospatent to make the following decision: to satisfy the objection received by the 02.03.2016, to invalidate the patent of the Russian Federation for invention No. 2358762 in full,"  the document says.

An American company can file an appendix.

Thus, the board approved the operative part of the decision to invalidate the patent in full, which was announced on October 20, 2017. As Forbes was told in the company "Blockade," which is developing an analogue drug - "Acellbia," the total volume of the Russian market for rituximab for the treatment of rheumatoid arthritis is more than 1 billion rubles. According to the public procurement website , in 2017, the volume of tenders for the purchase of rituximab exceeded 1.2 billion rubles.

 A 2003 patent granting a monopoly on a method of treating rheumatoid arthritis known from 2001-2002 was repealed.

Evrope canceled such a patent several years ago, but  in the USA disputes on the American patent are still ongoing, due to the fact that  in Europe, the Russian Federation  and the USA there are different ways to assess what the concept of" known "means . In particular,  in the Russian Federation and Europe it was proved that this method is known, because  from 2001-2002 it was already used in scientific research to treat patients, but  in the United States the court has not yet accepted the arguments of generic companies , "the lawyer explains
.

For rituximab, Biocad is not arguing with its daughter Roche for the first time: in 2015, a subsidiary of Roche tried to ban a Russian company from issuing an analogue under another patent describing the treatment of cancer with rituximab. In 2016, in order to avoid any possible claims from Roche, Biocad began a patent dispute in order to "end the monopoly of the American company ahead of schedule , as it tried to extend it using patent protection of an already well-known drug for the treatment of rheumatoid arthritis," he clarifies. What happened now is a "patent murder," Moskvich explains. Thus, if the American side does not challenge the decision , it will no longer  be able to go to court on this patent.

The decision of the Chamber on Patent Disputes showed  that Rospatent can successfully interpret and apply both old  and new norms of law in order to maintain a balance between protecting the interests of Russian citizens and  protecting the rights of patent holders, said the director of the Intellectual Property Department. For Russian farm companies, this means that Rospatent will be "more nuanced, albeit for a long time, to evaluate the arguments" for ' and "against' when challenging patents," the Forbes interlocutor concludes.

The position of Rospatent, which Moskvich called "nuanced," can stimulate claims by Russian manufacturers to abolish "evergreen" patents for other drugs.

Inna Panteleeva, head of the Roche legal, compliance and corporate communications department in Russia , in an interview with Forbes, said that the patent challenge initiated by Biocad in Rospatent lasted a year and a half. The company will now assess the prospects for challenging the decision.

 Biocad expressed confidence that the decision has "a tremendous impact both on the development of the domestic farm industry  and on the increase in the availability of high-quality drugs for patients."

 The company explained that the disputed patent was one of the so-called secondary or  "evergreen" patents.  With its help, according to a representative of the Russian biotech company, Western pharmaceutical companies are holding market monopolies on "vital drugs and killing local competition in different markets."

"The presence of such patents also allows companies to patent holders not to develop new technologies and not release new drugs to the markets until the      expiration of old patents, thereby artificially retaining the development of new medicines and collecting maximum profits from patients in a particular country," says a company representative.

According to some estimates, in pharmacology, such secondary patents account for more than 70%, Anton Pushkov, managing partner of the Skolkovo Intellectual Property Center, estimated for Forbes.

The proceedings lasted  from March 2, 2016 to  October 20, 2017. The parties attracted two different members of the board and the Russian Academy of Sciences (RAS) to make a final decision. The Russian company notes that the basis for the illegality of issuing a patent lies in its inconsistency with the criterion "the presence of an inventive level."

"In other words, Genentech tried to get a tool for illegally extending the monopoly position of the pharmaceutical manufacturer on the market for a method of treating rheumatoid arthritis, which has already been widely known among specialists since 2001 ," the Forbes source said.

Biocad was represented by lawyer Anna Khrustaleva, director of intellectual property of the company Andrei Moskvich and medical adviser Anton Lutsky. Muscovite in a conversation with Forbes noted that the most difficult thing was to change the board's view on how it is necessary to evaluate the criteria for the patentability of patents issued in the early 2000s, since at that moment "slightly different rules of law" were applied.

"But  since equivalent disputes on the drug rituximab are conducted in the United States  and conducted in Europe, the panel was able to come to the right solution, relying on Russian practice and international experience," he concludes.

 The company emphasizes that the solution will make the cost of the drug in Russia more affordable.

A market source , who wished to remain anonymous, explained to Forbes that in the  early  2000s Rospatent massively made decisions about "evergreen" patents in favor of their holders. However, it subsequently turned out that  Western companies have the right to almost all medicines, which did not allow Russian pharmaceutical companies to develop. As a result, domestic manufacturers began to fight for a revision of the approach to such patents  and the rituximab case is an indicative case of victory over a global player.

2016

FAS rejected R-Pharm's claims against Biocad and Pharmstandard

At the end of June 2016, the Federal Antimonopoly Service (FAS) recognized the claims of R-Pharm, the distributor of the Indian company Dr. Reddy's, at the bidding of rituximab, a drug against blood cancer, as unfounded. The "Third Extra" rule fulfilled its role and protected the investments of Russian companies in the development of the domestic pharmaceutical industry. Two Russian companies submitted bids for the tender, which invested in organizing the production of a complex high-tech drug in Russia - BIOCAD and Pharmstandard (localization of the production of rituximab developed by Roche) and one foreign Dr. Reddy's. Under the "Third Extra" rule, a third company's application was rejected. Read more here.

Lawsuit against Roche in New York City court over cancer drugs

 In June 2016, Biocad filed a lawsuit  in federal court New York  against Roche Holding AG, as well as F. Hoffman-La Roche, the American Genentech affiliated with them and the Russian group R-Pharm"." The lawsuit involved  three cancer drugs from Roche (Avastin, Herceptin and Rituxan) and their generics from Biocad, launched on the market from 2014 to January 2016. The Russian manufacturer accused the competitor of  lowering the prices of these drugs in  Russia order to destroy the Biocad business and prevent its drugs not only to the Russian, but  also to the American market. USA In exclusive rights to all three drugs , Roche expires in 2018-2019.

The Swiss company's annual revenue from the production and sale of three drugs is about $20 billion, and half of this amount falls on the United States, which remains the most attractive market for the company, the statement of claim said. Roche told Vedomosti that they were aware of this lawsuit, but the accusations were "groundless." As a result, the Federal Court of the Southern District of New York left the Biocad lawsuit pending. 

2015: First shipment of products to non-CIS countries

In 2015, Biocad made the first shipment of products to non-CIS countries. The main volume of exports was formed at the time of registration and entry into the market of biosimilars based on monoclonal antibodies produced by Biocad, the company noted.

2014: Registration of Rituximab biosimilar

On April 4, 2014, the Ministry of Health of the Russian Federation registered the first biosimilar of the domestically produced drug rituximab in Russia.

2013: Revenue - 3 billion rubles

In 2013, the company's revenue amounted to 3 billion rubles.

2010: Monoclonal Antibody Drug Development Begins

In 2010, under the leadership of Dmitry Morozov, Biocad launched a project to create drugs based on monoclonal antibodies: rituximab, trastuzumab and bevacizumab biosimilars for the treatment of cancer. Previously, vital drugs were presented only by imported manufacturers.

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