AstraZeneca Russia AstraZeneca Russia

AstraZeneca is a biopharmaceutical company that is one of the five leaders in the international pharmaceutical market. Sales of the company are carried out in more than 100 countries of the world, including in Russia. Russia is one of the priority markets for AstraZenek. About 50 original drugs of the company are registered and allowed for use in the country. In addition, in 2015, AstraZenek launched a local pharmaceutical plant to increase the availability of effective and safe medicines for Russian patients. The company has representatives in 73 Russian cities, and the number of employees of AstraZenek Russia employs about 1,400 people.

• AstraZeneca Industries

Performance indicators

2020: Sales growth 28% to $314 million

On February 11, 2021, AstraZeneca"" reported Zdrav.Expert financial results for 2020. Sales of drugs Russia in increased by 28% and amounted to 314 million. US dollars

History

2023: AstraZeneca remains in Russia. The company has found a way to conduct clinical trials in the Russian Federation

On October 12, 2023, it became known that AstraZeneca will be testing a new drug in Russia to prevent the coronavirus COVID-19. This procedure is required before registration.

Earlier, the company announced the suspension of tests in Russia. The reason for this was the beginning of the special operation of the Russian Federation in Ukraine. Kommersant notes that AstraZeneca is the only Western pharmaceutical company that has already twice received permits from the Russian authorities for local trials of new drugs in 2023. In addition to testing a drug for the prevention of coronavirus, in February the company received permission for the second phase of testing the drugs ceralasertib and durvalumab in patients with non-small cell lung cancer.

AstraZeneca will test a drug for the prevention of coronavirus in Russia

This time, the second phase of the pre-registration study of the drug will take place in Russia. It is based on monoclonal antibodies and is designed to prevent COVID-19. The drug currently exists under the working name AZD3152, permission to test it was received by the company in August 2023. 130 test subjects will take part in the study. The completion of the study is planned in the summer of 2024, at the moment AstraZeneca is at the stage of recruiting participants.

AstraZeneca is the only Western pharmaceutical company remaining in Russia after the outbreak of hostilities. Previously, companies such as Pfizer, MSD, GSK, Novartis, Roche announced their departure from the country.

Despite the company's statement that it does not plan to conduct "global clinical research" in Russia, Russia is one of the countries participating in the study of "efficacy, safety and neutralizing activity," which has been going on since the end of 2022.

According to Ilya Yasny, head of the scientific expertise of the LanceBio Ventures venture fund, the focus on local research instead of international ones significantly simplifies the procedure for a pharmaceutical company and solves several logistical and bureaucratic problems at once. So, in international research, the company is obliged to export patients to laboratories abroad. At the same time, the regulator from the EU or the United States must have access to any center that took part in the tests.^[1]

2022: Artificial intelligence will help more effectively identify patients with kidney disease

AstraZeneca and resident Skolkovo"""" K-Skye will develop digital algorithms ones to speed up doctors' interpretation of symptoms and the results of studies of patients with chronic kidney disease (CKD). More. here

2021: Agreement with GE Healthcare aimed at developing training programs for healthcare professionals

On 19 November, GE Healthcare and AstraZeneca entered into a cooperation agreement aimed at developing training programs for healthcare professionals to continuously improve their competencies and increase access to the world's best practices in the diagnosis and treatment of cardiovascular disease (CVD). Read more here.

2019

Drug sales growth by 35%

On February 19, 2020, AstraZeneca reported that sales of the company's drugs in Russia in 2019 increased by 35% (40% at constant exchange rates).

Creation of a register of patients with severe bronchial asthma in the Russian Federation

On December 19, 2019, AstraZeneca announced that in 2018 the Russian Respiratory Society, with the support of AstraZeneca, initiated a 5-year study to create a "Register of patients with severe bronchial asthma in the Russian Federation" who are being treated/monitored in outpatient clinics, medical and preventive institutions and dispensaries of the Russian health care system. Read more here.

Opening of the Center for Innovation and the Internet of Things in Healthcare in Skolkovo

On October 22, 2019, AstraZenek announced to TAdviser the opening of the Center for Innovation and the Internet of Things in Healthcare at Skolkovo. The center will become a platform for combining the experience and efforts of business, the state, scientific institutes and startups, health care institutions and medical associations. His work is designed to promote the transformation and development of the health care system in Russia.

The ceremony was attended by Minister of Health Veronika Skvortsova, Chairman of the Skolkovo Foundation Arkady Dvorkovich, First Deputy Minister of Industry and Trade Sergei Tsyb and heads of partner companies.

The center was created by the Skolkovo Foundation on the basis of the Cluster of Biological and Medical Technologies together with Russian and international companies with the support of the main specialists of the Russian Ministry of Health. The opening of the Center was an important step in the history of fruitful cooperation between Skolkovo and AstraZenek, which began in May 2017.

Modern digital and biomedical technologies make it possible to make the process of screening, diagnosis, treatment and rehabilitation of the patient as effective as possible, however, it requires an integrated approach and the most thorough planning of the process of introducing such developments. That is why the Ministry of Health welcomes the initiative of the Skolkovo Foundation to create a Center for Innovation and the Internet of Things in Healthcare, which is designed to demonstrate models for the integrated application of modern technological developments along the entire "route" of the patient and provide medical institutions with a convenient tool for confident navigation in the sometimes difficult world of innovative developments. noted Veronika Igorevna Skvortsova, Minister of Health of the Russian Federation

The opening of the Center is the next stage in interdisciplinary cooperation between Russian and international companies and research organizations from various fields of industry and science. They are united by common tasks to improve health care and develop the Russian economy through the growth of production and scientific competencies, said Sergey Anatolyevich Tsyb, First Deputy Minister of Industry and Trade

The creation of the Center was announced in June 2019. The memorandum of intent was signed by the Skolkovo Foundation, the international biopharmaceutical company AstraZenek, QIAGEN, Radiotherapy Equipment Factory LLC (R-Pharm group of companies), Russian Post, Sberbank, Stentex and Nokia. PJSC VimpelCom (Beeline) and GE Healthcare also joined the agreement.

The Center for Innovation and the Internet of Things in Healthcare is a special form of introducing modern technological solutions for medicine by creating prototypes of therapeutic complexes, demonstrating and testing them, and then scaling them into healthcare institutions throughout Russia. In addition, it is planned to create an educational center and a space for interaction between startups, the solutions of many of which are already presented in the Center.

The healthcare sector is a high-tech industry, and the Internet of Things is one of the innovations that is already being actively introduced into medical practice. It is with the Internet of Things that high rates of digital transformation are associated. The potential of the Internet of Things is not exhausted by the management of clinical and diagnostic processes, but allows you to bring to a different level the analysis of medical information and planning in healthcare, commented Natalia Polushkina, Vice President, Executive Director of Skolkovo Foundation Biomedical Technology Cluster

The request for comprehensive solutions in areas such as disease prevention and the preservation of patient health is obvious. 'R-Pharm' seeks to provide the healthcare system with the necessary tools, including through the convergence of healthcare methods and their localization. I am confident that our joint project with partners will play an important role in the implementation of this approach,

The center is a platform that unites representatives of industry, digital technologies, science and medicine within the framework of a single goal to develop effective solutions to improve the quality of life and health of patients, as well as the treatment of diseases that make the most significant contribution to the morbidity structure of the Russian population. shared Irina Panarina, General Director of AstraZenek, Russia and Eurasia

The Center for Innovation and the Internet of Things in Healthcare is created with the support of the Ministry of Health of the Russian Federation. It aligns therapeutic areas and will contribute to communicating information about the therapeutic solutions presented at the Center to medical organizations.

The center will create and implement innovative developments in four therapeutic areas with the greatest contribution to the structure of morbidity: cardiology - acute coronary syndrome (ACS), oncology - lung cancer, endocrinology - type 2 diabetes mellitus, pulmonology - bronchial asthma.

Representatives of the professional community will be able to familiarize themselves with patient support areas in each therapeutic area: mobile applications for patients for disease control, as well as modern patient monitoring devices that communicate with a single information system and doctor.

In addition, the Center presents special services for each group of diseases:

• Modern technologies of screening programs using low-dose CT and the ability to process information using artificial intelligence, which will allow detecting lung cancer at earlier stages; solutions on modern endoscopic methods, digital technologies in morphological diagnostics, modern approaches in the field of molecular genetic testing to improve the quality of diagnostics in oncology while reducing the time for its implementation.
• Technologies for screening using electronic questionnaires and a medical decision support system. This will help to conduct pre-medical express diagnostics to identify diabetes mellitus and possible complications, as well as to assess cardiovascular risk.
• A central control room that will help shorten the journey of a patient with myocardial infarction from primary medical contact to the operating room with percutaneous coronary intervention; a system of location marks, which allows to reduce intra-hospital time losses; solutions for vascular centers and telemedicine technologies for helping patients on the outpatient stage.
• Technologies for improving the verification of bronchial asthma, determining the degree of control and severity of the disease, optimizing the patient's route to specialized specialists.

In the future, it is planned to expand the solutions presented at the Center in other therapeutic areas.

Supreme Court upholds originator in generic patent protection dispute

On August 16, 2019, it became known that the Supreme Court of the Russian Federation (RF Armed Forces) resolved a dispute with Jodas Expoim in favor of AstraZenek on the protection of exclusive rights to the reference antitumor drug gefitinib. The Supreme Court refused Jodas Expoim to transfer the cassation appeal for consideration in the court session of the Judicial Collegium for Economic Disputes of the Armed Forces of the Russian Federation, upholding the judicial acts that oblige Jodas Expoim to revoke the registration certificate and the price of the generic, and also prohibit Jodas Expoim from submitting documents for re-registration of the generic before the expiration of the patent for the reference drug.

As reported, earlier AstraZeneca filed a lawsuit against Jodas Expoim, the manufacturer of the reproduced drug, demanding to eliminate the threat of violation of the AstraZeneca patent and cancel the registration of the generic and the price of it. The courts found the claims of the originator justified, but Jodas Expoim filed a complaint with the Supreme Court.

The Armed Forces of the Russian Federation supported the conclusions of the appellate instance and the Intellectual Rights Court, considering the registration of the reproduced drug and the price of it in the period before the expiration of patent protection of the reference drug by actions that pose a threat of patent infringement, which must be stopped.

As you know, in 2009, the Presidium of the Supreme Arbitration Court of the Russian Federation, in resolution No. 2578/09, considered that actions to register the drug and its prices did not violate the rights of the patent holder. This approach was quite widespread both in judicial practice and in the work of other state bodies.

The judicial act may be a turning point in the proper protection of the intellectual property of pharmaceutical companies developing medicines.

Insufficient protection of intellectual rights in pharmaceuticals - directly or indirectly - entails an increase in mortality, a decrease in the life expectancy of the population, and an increase in budget costs. The direct decision of the Supreme Court of the Russian Federation in favor of the manufacturer of the patented drug confirms positive changes in the solution of acute issues of intellectual property development. We hope that it will become a model for dozens of similar disputes related to patent infringement in pharmaceuticals. told Irina Panarina, General Director of AstraZenek Russia and Eurasia

Jodas Expoim registered the generic (July 2015) and the marginal price for it (April 2018) before the expiration of the patent for the original drug AstraZeneca. In May 2018, AstraZeneca filed a lawsuit, and in February 2019, the arbitration court decided to protect the patent. At the same time, for the first time in disputes of this kind, the court ordered the offender to submit applications to cancel the registration of the reproduced drug and the maximum selling price for it, and also forbade re-registration of the generic before the expiration of the AstraZenek patent.

Signing a memorandum on the establishment of the Center for Innovation and the Internet of Things in Healthcare in Russia

On June 6, 2019, a memorandum was signed between the international biopharmaceutical company AstraZenek, the Skolkovo Foundation, Nokia, Factory of Radiotherapy Technology LLC (R-Pharm group of companies), Russian Post, Stentex and Sberbank on the creation of a Center for Innovation and the Internet of Things in Healthcare on the basis of the Fund, which is scheduled to open in October 2019. The partner of the center will also be QIAGEN. The center will become a platform for combining the experience and efforts of business, the state, scientific institutes and startups, health care institutions and medical associations, to achieve more comfortable and accurate management of the disease treatment process, promote the transformation and development of the health care system in Russia and ensure the achievement of national goals in the field of health, demography and digitalization.

The Center for Innovation and the Internet of Things in Healthcare is a form of introducing modern technological solutions for medicine by creating prototypes of therapeutic complexes, demonstrating and testing them, subsequent scaling into healthcare institutions throughout Russia, creating an educational center and space for startup interaction.

On the basis of the center, spaces will be created for demonstrating and testing innovative, digital therapeutic complexes, as well as solutions in the field of the "Internet of Things" for health care in order to develop and promote best practices in the diagnosis, treatment and follow-up of patients in various therapeutic areas. In addition, an education center will be created to solve the problem of providing the industry with highly qualified personnel. In order to develop innovative projects in the field of health, a workspace for startups is provided, where a platform for training, exchange of experience and presentation of ideas will appear.

Within the framework of the Center's activities, interaction with various partners in the field of diagnostics, medical equipment and digital technologies is envisaged to create an alliance in the field of the Internet of Things in health care and the development of an innovative health care system.

The center in Skolkovo will become the Russian localization of the AstraZenek project in China (Wuxi city, Jiangsu province), where, in partnership with the government, industry representatives, educational institutions, research and medical institutes, the Healthcare IoT Innovation Center was created. The Center in China is an open strategic platform to promote commercial solutions in innovative healthcare.

One of the mechanisms of the national goal of achieving an average life expectancy in Russia over 80 years (80 + by 2030) is to reduce preventable mortality and preserve an additional 230 thousand lives in 2024. In this regard, the initial therapeutic areas were selected, characterized by wide prevalence and social significance: cardiology - acute coronary syndrome, oncology - lung cancer, endocrinology - type 2 diabetes mellitus and pulmonology - bronchial asthma. The Center for Healthcare Innovation will allow integrating data into a single information system, creating patient registers, optimizing the patient's path using innovative technologies that allow achieving better results in the diagnosis and treatment of diseases, saving the doctor's time at the appointment, ensuring standardization of the implementation of clinical recommendations, reducing mortality rates and reducing healthcare costs for basic therapy and treatment.

We believe that the Center for Innovation and the Internet of Things in Healthcare in Russia will become a platform for solving the problems of the Russian health care system, providing medical and digital solutions that are designed to improve the infrastructure of the regional health care system and improve the results of therapy. AstraZenek's international experience in establishing effective public-private engagement in R&D innovation and development will help ensure that the center meets the unmet needs of the industry by providing comprehensive solutions to patients and communities.

"Symbicort Turbuhaler" received the indication "mild bronchial asthma" for use in Russia

The international biopharmaceutical company AstraZeneca announced the registration on April 11, 2019 of the indication for budesonide/formoterol Symbicort Turbuhaler (160/4.5 μg/dose) - mild bronchial asthma (AD). You can take the drug "on demand" to stop attacks and symptoms in adults and adolescents 12 years and older.

According to the prescribing information, Symbicort Turbuhaler is suitable for the treatment of AD of any severity when inhaled glucocorticosteroids are appropriate. Expanding the indications for the use of the drug will allow achieving general control of the disease, including alleviating symptoms and reducing the risk of exacerbations in more Russian patients with mild, moderate and severe AD, according to the company.

The presence of an inhaled glucocorticosteroid - budesonide and a long-acting beta2-agonist with a quick onset of action - formoterol provides at the same time the pathogenetic and symptomatic effect of the drug, which allows you to relieve inflammation in the bronchial wall and stop attacks and symptoms in patients with AD, - explained the representatives of AstraZenek.

In general, budesonide/formoterol Symbicort Turbuchaler (160/4.5 μg/dose) can be used in the following regimens:

• A. for the relief of attacks/symptoms with anti-inflammatory action on demand (in patients with mild AD);
• B. as maintenance therapy and for the management of attacks/symptoms with anti-inflammatory effects (in patients with moderate to severe AD);
• C. as maintenance therapy (in patients with moderate to severe AD).

As explained in the company, the expansion of the indications for this drug was made possible thanks to the data obtained in the studies of the SYGMA clinical program (SYmbicort Given as needed in Mild Asthma). Based on the results of these studies, the efficacy of budesonide/formoterol Symbicort Turbuchaler (160/4.5 μg) in the "on demand" mode, the effect on the frequency of severe exacerbations in patients with mild AD was significantly higher in comparison with short-acting beta2-agonist (CDBA) therapy in the "on demand" mode (the frequency of severe exacerbations in the budesonide/formoterol "on demand" group is 64% lower) and comparable to regular therapy with budesonide plus CDBA "on demand" at a much lower (75%) steroid load.

2018

The court did not satisfy the cassation appeal of AstraZeneca in the case of Formisonide-nativ

On November 7, 2018, the Moscow Arbitration Court refused Astrazeneka Pharmaceuticals LLC to satisfy the cassation appeal in the A41-90766/2017 case. The operative part of the ruling was published on the court's website on November 12, 2018. Read more here.

Lost court against "Nativa" in the case of "Formisonides-nativ"

On February 28, 2018, the Moscow Region Arbitration Court decided to refuse Astraseneka Pharmaceuticals LLC to satisfy the claims against the Russian company Nativa in the A41-90766/2017 case.

In November 2017, Astrazeneka Pharmaceuticals filed claims against Nativa LLC for recognition of the defendant's actions as unfair competition. The plaintiff stated that the defendant misled consumers, patients, medical specialists, government customers, as well as distributors regarding the consumer properties and quality of Formisonide-nativ, the first Russian generic drug for basic therapy of bronchial asthma.

The court also decided to refuse to satisfy the requirements for amending the documents contained in the registration dossier for Formisonide-native. As part of the court session, the operative part of the court decision was announced. Information on the adopted judicial act is published on the website of the Arbitration Court.