FIGURES

  • In 2019, the company’s earnings totalled RUB 7.5 bn, which is 60% higher than in 2018 (RUB 4.7 bn).
  • The total amount of investments exceeds RUB 500 mln.
  •  NANOLEK’s R&D experts evaluated 80 new medication ideas.
  • 5 new registration certificates for medications were received (4 in the Russian Federation and 1 in Azerbaijan).

“We are happy with our results, the company demonstrates sustainable growth that hopefully will persist inspite of current market fluctuations,” said Vladimir Khristenko, President of NANOLEK.

WITHDRAWAL FROM THE LIST OF RUSNANO PORTFOLIO COMPANIES

“NANOLEK became an independent company, now we count on our efforts only, and I believe in our team, we will move forward in accordance with our development strategy,” said Vladimir Khristenko, President of NANOLEK.

 As of August 14, 2019, Rosnano JSC ceased to be a member of the Russian biopharmaceutical company NANOLEK after selling its 33.33% stake in the charter capital to other shareholders.  The proceeds of sale exceeded the amount of investments by two times and amounted to RUB 2.35 bn.

VACCINE BUSINESS DEVELOPMENT AND SUPPLIES UNDER GOVERNMENTAL CONTRACTS

In 2019, the company continued strengthening its positions in the vaccine business, being NANOLEK’s priority. 

NANOLEK proceeded to the third stage of pneumococcal vaccine clinical research. This project assumes gradual transfer of technologies resulting in the establishment of a full vaccine production cycle in the Russian Federation.

Usually, children under 5 years and elderly people suffer from pneumococcal disease. Diseases induced by pneumococcus are dangerous and may result in severe complications. Vaccination helps decrease the number of severe invasive pneumococcal infections, pneumonia cases and therefore cut healthcare costs and increase the length and quality of life of patients suffering from chronic non-specific lung diseases.

Several agreements were concluded with companies in order to continue development of NANOLEK’s vaccine business, being the company’s priority:

  • Sanofi Pasteur - the project to localize production of a combined conjugated vaccine for meningococcal disease prevention was launched. The partnership will broaden opportunities for protection of Russian children from meningococcal disease (MD).
  • Creation of a joint venture INVAK together with the Chumakov Scientific Centre was a landmark event. The company will produce the first entirely domestic inactivated polio vaccine (IPV). This project illustrates the process of transfer from localisation of a medication to a complete production cycle, which is one of NANOLEK’s priorities.

In 2019, a 2-years’ governmental contract for vaccine supply for the National Vaccination Schedule (for 2019-2020) was concluded for the first time in NANOLEK’s history. Under the contract, NANOLEK fulfilled the first year’s obligations in full: it successfully completed the first stage of supplies of a paediatric five-component combined vaccine (Pentaxim®) produced by the Nanolek’s biomedical cluster. In total, 3.5 mn vaccine doses were produced and supplied in 2019, which allowed protecting approx. 1 mn children from five dangerous infections, i.e. tetanus, pertussis, diphtheria, poliomyelitis and haemophilus influenzae type b.

We would like to remind you that haemophilus influenzae type b vaccination is currently made for risk groups only, while the protection of healthy children from this infection is achieved either according to the regional schedules (Moscow, Saint-Petersburg and several other regions) or on parent’s account. Currently, only three countries, including Russia, have not introduced the haemophilus influenzae type b vaccines as part of the scheduled immunisation of all children during the first years of life according to vaccination schemes recommended by the WHO.

MEDICATION PORTFOLIO

NANOLEK focuses on prevention and treatment of socially significant diseases. NANOLEK’s diversified product portfolio includes drugs for treatment of HIV, orphan, oncological diseases, etc.

Partnerships

The company pays great attention to developing of partnerships with major industry players. In 2019, long-term agreements for production and transfer of technologies were concluded with leading corporations:

  • NANOLEK strengthened its oncological drug portfolio by launching a joint project with Janssen in order to localize Darzalex® (daratumumab) used to treat multiple myeloma. The medication is the first human monoclonal anti-CD38 antibody approved for this type of disease;
  • NANOLEK and Merck announced the launch of a complete production cycle of one of key medications Concor® used to treat arterial hypertension, coronary heart disease and chronic cardiac failure. The medication will be produced by NANOLEK’s production plant in Kirov region in full compliance with the GMP standards;
  • For the first time in its history, NANOLEK enters the veterinary vaccine market, an agreement was signed with the market leader MSD Animal Health (full-cycle production of veterinary vaccines in Russia).

Medications to treat HIV

In 2019, NANOLEK registered its own prescription drug Atazanavir-NANOLEK® to treat HIV. The complete production cycle of a finished dosage form will be produced at NANOLEK’s production site in Kirov region with a capacity to produce more than 100 thousand packs per year, while the price of the medication will be lower than that of analogues available in the market. In May 2019, Darunavir-NANOLEK® was registered (thus, in 2019, the ART drug portfolio includes the following medications: atazanavir, darunavir, lamivudine-zidovudine, tenofovir, efavirenz as well as valganciclovir also used to treat cytomegalovirus infection).

Orphan diseases

The first stage of localisation of production of an original medication Hunteraza® (idursulfase beta) in the Russian Federation used to treat the orphan disease mucopolysaccharidosis type 2 (MPS 2), being a severe disease that causes disability, was completed. Since January 1, 2019, MPS 2 has been included in the 14 Nosologies List (NL) and is financed at the expense of the federal budget. In February 2019, Hunteraza® was included in the standards for Hunter syndrome treatment.

Today, NANOLEK is the only Russian company that has set up a local production in Russia to manufacture drugs for the treatment of this disease. The drug is produced at NANOLEK’s biopharmaceutical complex in Kirov region. This allows ensuring continuous supplies of this medication to Russian patients suffering from this rare disease. The domestic production also helps decrease financial burden on the federal budget as the price of use of Hunteraza® is more than 20% lower as compared to the alternative enzyme replacement therapy method.

DRUG LABELING

NANOLEK was one of the first companies to implement the Labeling project. On November 21, 2019, NANOLEK’s biomedical complex in Kirov region manufactured a labelled commercial batch of Hunteraza® used to treat the orphan disease mucopolysaccharidosis type 2 (MPS 2) included in the 14 Nosologies List. The Company has successfully implemented the labelling software and hardware. The active testing of communication exchange in the system for medication flow monitoring was completed together with partners. Today, we also produce labelled Fraxiparine at our biotechnological production facility in Kirov, and we prepare production of labelled series of Pentaxim® combined vaccines supplied for the needs of the National Vaccination Schedule.

CORPORATE SOCIAL RESPONSIBILITY, TAX PAYMENTS TO THE BUDGET OF KIROV REGION

Please keep in mind that NANOLEK’s production biotechnological complex is located in Kirov.

NANOLEK is a socially responsible company that pays great attention to the development of the Kirov region. Currently, more than 700 workplaces for highly skilled workers have been created at NANOLEK’s biopharmaceutical complex, of which 170 employees graduated from the Vyatka State University, 35% are the specialists in the area of biotechnologies.

NANOLEK is one of the founders of the industrial biotechnology cluster in Kirov region established at the initiative and with active participation of Igor Vasilyev, Governor of Kirov region.

In 2019, NANOLEK became a member and one of the founders of a world-class research and education centre BIOPOLIS in Kirov region. Other members of the association include Kurchatov Institute National Research Center and Chumakov Federal Scientific Center for Research and Development of Immunobiological Drugs of the Russian Academy of Sciences. The main goal behind the creation of the research and education centre was to build a distributed scientific and production cluster, a tool to achieve a global leadership in immunobiology, one of the most promising areas of world science development.

As part of research and education centre’s activities, it will develop new drugs in order to ensure epidemiological safety and medicinal independency of the country, develop innovation technologies for the production of those drugs and arrange projects for their implementation. Training and advanced training of qualified scientific, technical and managerial workers along with international cooperation will become an important part of center’s operations.

NANOLEK makes its contribution to the regional fiscal capacity (by paying taxes to the local budget). In 2019, tax payments totalled approx. RUB 100 mn, which is 2.5 times more than in 2018 (RUB 40 mn).

COOPERATION WITH UNIVERSITIES. Basic University: Vyatka State University

NANOLEK entered into a cooperation agreement with the Vyatka State University. Today, NANOLEK employs 170 graduates of the Vyatka State University.

NANOLEK’s representatives take an active part in the life of the basic university. In spring, NANOLEK arranged an excursion into its production facility for schoolchildren specialising in Chemistry and Biology as part of the VIII Week of High Technologies and Technical Entrepreneurship. The schoolchildren visited several laboratories (chemical and analytical, microbiological, biochemical) and inspected all production premises and equipment; NANOlock intellectual game was organised for students.

In June 2019, NANOLEK’s employees acted as members of the state attestation board, and in July they assessed bachelors and future microbiologists’ theses.

AWARDS AND RANKING

In 2019, Mikhail Nekrasov, General Director of NANOLEK, was awarded the Annual Prize “Person of the Year 2019. Large Business and Social Sector” in the nomination “Production Man of the Year”. The award ceremony was held by the Business Class magazine supported by the Government of the Kirov region.

We would like to remind you that Mikhail Nekrasov is in his second year in office as deputy of the Legislative Assembly of the Kirov region. He is a member of the Committee for Environmental Safety and Natural Resource Management as well as the Committee on Social Affairs. He monthly receives local dwellers at the public reception office to address local issues, actively participates in regional social and cultural events. In 2019, he supported the following events: the 39th All-Russian Ski Marathon Shizhma, traditional festival Istobensky Ogurets, ХIХ Intermunicipal Rifle Shooting Competition.

In 2019, NANOLEK was awarded a prestigious national award in import substitution and transfer of technologies Prioritet-Pharma for the development and establishment of production of the inactivated polio vaccine and was ranked first in the category Fast Growing Major Companies of the reputable TekhUspekh rating evaluating Russian companies that rapidly evolve, demonstrate dynamic turnover and innovative technologies in their work.

NANOLEK managers were listed in the Top-1000 Russian Managers rating released by the Managers Association of Russia and Kommersant Publishing House:

  • Top-250 Senior Managers: Vladimir Viktorovich Khristenko, President;
  • Top-100 Commercial Directors: Maksim Viktorovich Stetsyuk, Executive Director.

 

 

 

 


NANOLEK is a modern fast-evolving Russian biopharmaceutical company with its own high-tech complete cycle production compliant with GMP and ISO standards. NANOLEK specialises in the production of import-substituting and innovative pharmaceuticals, both in-house developed and invented with the help of international partners, focusing on the prevention and treatment of socially significant diseases. The company has unique experience in the area of transfer of technologies as part of partnership with the leading international pharmaceutical companies (Merck, Sanofi, Novartis, Egis, Celltrion, Riemser, etc.)

The company is now one of the Russia’s leading producers of paediatric vaccines. NANOLEK’s diversified drug portfolio covers the following therapeutic areas: vaccines, drugs for treatment of HIV, oncological diseases, etc.