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List of innovation projects
Belbiopharm Concern
 

The strategy of development of Belbiopharm Concern for the years 2006-2010 is based on the priority development of the production of vitally necessary and socially essential medicines for the purpose of decreasing the dependence of the domestic health service on the medicine import, improvement of the quality and competitiveness of the output products at the cost of introduction of the state-of-the-art technologies, GMP norms and rules into the production, creation of the conditions for increasing the volume of export deliveries to the near- and far-abroad countries.

The implementation of the programme measures will make it possible to achieve the following results in 2010: increase of the share of innovative products in the total volume of the shipped products up to 15 per cent; decrease of the degree of wear of the active part of the fixed industrial and production-related assets down to 68 per cent and to increase share of the expenses for the equipment, tools and inventory in the investments in the fixed capital up to 65 per cent.

The development of the pharmaceutical industry will take place within the framework of the State Programme of Pharmacological Support of the Republic of Belarus till the year 2010. The programme is aimed at the expansion of the nomenclature of the medicines being produced in the established scientific trends, the results of which are already at the stage of launching and will be implemented. Besides, the search and development of new trends providing for creating the import-substituting products is also supposed.

The scientific support of the development of the branch will be provided within the framework of the State Scientific and Technological Programme “New Medicines”, innovative projects and R&D plans to be financed from the means of the Innovative Foundation in the priority directions “Technology of the Chemicals and Pharmaceuticals” and “Biotechnology”.
Within the framework of scientific support it is planned to solve a number of medical, social and economical problems, such as:

  • Introduction of more efficient methods of pharmacotherapy of diseases, with have high social importance, including those related to the cardiovascular pathology, diseases of the respiratory and digestive systems, inflammatory and infection diseases, immunodeficient conditions, shortening of the duration of the treatment of the herpetic infection and diseases in the traumatology, stomatology, implantology, etc.
  • The improvement of the pharmacological support for treatment of the diseases of the high-risk categories of the population (pregnant and nursing women, children and adolescents, elderly-age people).
  • Optimization of the medical and social assistance to the persons having been suffered from the accident at Chernobyl Nuclear Power Plant by introducing a complex of rehabilitation, sanitation and prophylactic means and drugs on the basis of high-purity amino acids and their derivatives.
  • Decrease of the dependence of the pharmaceutical enterprises from imported raw materials, increase of their production potential and ensuring the positive dynamics of the development.

Expansion of the assortment of the produced drugs by the end of the five-year period up to 680 items with bringing the share of the drugs from the list of the basic ones up to 50 per cent.
The further development of the scientific-and-technical activities will take place in the following directions:

  • creating the technologies and launching of the production of the generic-series drugs from amongst the most efficient ones included in the standard protocols of therapy of common diseases approved by the WHO. It will make it possible to implement successfully the import-substitution programme by saturating the market of the Republic with the drugs capable of substituting the expensive imported analogues;
  • development and launching of production of new original highly efficient drugs on the basis of imported and domestically produced substances as well as vegetable, animal and microbial raw materials;
  • satisfaction of the demand of the internal market for the means for prophylaxis and treatment of agricultural animals, biological fertilizers, biostimulant of the growth and agents for protection of plants, fodder and food additives, enzymatic agents as well as substances for the pharmaceutical industry.

Within the framework of the State Scientific and Technological Programme “New Medicines”, it is planned to complete the development and proceed to launching the production of the drugs of various therapeutic action such as antiarrhythmic tablets Amiodarone, ointment Procelanum, eye ointments Ancitabine Hydrochloride and Nuk-Leavir, substances and ÃËÔ of the antileukemic drug Fludarabelum, osteogenesis stimulators on the basis of bioactive hydroxyapatite, tablets of Emoxipine with antihypoxic and angioprotector action, L-thyroxin - thyroid hormone, triaza preparation having the thrombolytic anti-inflammatory action in the years 2006-2010.

The development and launching of production of the drugs of antineoplastic, cardiovascular anti-inflammatory and analgetic action, psycho-, neuro- and immunotropic drugs as well as hormonal and enzymatic agents:

  • Nitargal - preparation from the class of organic nitrates, having vasodilatory and cardiotropic action and intended for treatment of cardiovascular diseases;
  • Lithocell - prolonged-action drug for treatment of psychoneurological abnormalities;
  • Sulfagem - antithrombotic-action drug based on sulphated polysaccharides (hemicelluloses). This is an efficient antithrombotic-action drug ensuring the lysis of the thrombin clots and contributing to the prevention of their formation. The drug contains the heparinoid-sulfoether derivative hemicelluloses as an active basis, has low toxicity and innocuous in case of multiple administration;
  • Lakemok - drug in the form of water solution containing hydroxypropylmethyl cellulose, emoxipine and microquantities of mineral salts. It combines the protective and anti-oxidant actions in the protection of the endothelium and epithelium of the eye cornea and intended for use in the surgical and conservative treatment of the eye pathology;
  • Ribavirine (virasol) - prolonged-action antiviral ointment;
  • Antiherpetic drug based on the compounds with various mechanisms of the antiviral action ensuring the synergism of the antiherpetic effect and action upon the causative agents with the developed resistance to acyclovir;
  • Application formulation of drugs immobilized on the hydrogel matrix with the use of electron-beam treatment. The drugs contain the biologically active ingredients and intended for dressing and treatment of burning wounds, ulcers, abscesses, bedsores, scratches, infected wounds and other poorly healing lesions of large areas of skin;
  • Para-aminosalicylic acid antituberculous drug - drug for treatment of patients with the tuberculous forms resistant to drugs;
  • Medical and prophylactic drug for normalizing the microbiocenosis of the gastrointestinal tract. Probiotic based on bacteria which complement one another in respect for the spectrum of antagonistic action upon the pathogenic microflora and exert various actions upon various factors and links of the pathological process.

In perspective, the new competitive drugs and technologies will be developed and introduced into production on the basis of fundamental investigations of the Belarusian scientists:

  • Guaran - new-generation drug for treatment of the T-cell forms of leukemia. The drugs for treatment of this kind of disease are absent in Belarus and CIS countries;
  • Antihypertensive drugs - analogues of losartan and Valsartan;
  • New-generation photosensitizer for diagnostics and treatment of cancer;
  • New technologies of film coatings of drugs.

The step-by-step expansion of the nomenclature of high-purity amino acids and drugs based on them is planned at Grodno Drug Factory Republican Unitary Enterprise. The followings will be mastered additionally at the Enterprise by the year 2007:

  • Technologies of obtaining the three amino acids: L-proline, L-phenylalanine and L- histidine hydrochloride;
  • Technologies of obtaining the six derivative amino acids: dipeptide lysil-glutamyl, dipeptide glycine-glycine, acetylproline, acetylglutamine, arginine succinate, magnesium taurate.

As a result, the industrial production of the nine irreplaceable and most expensive amino acids and 6 substances based on their derivatives will be organized in the Republic.
The development of the 15 drugs of various therapeutic purposes will be completed and their industrial production will be organized:

  • Cardiovascular drugs (aspargit, lizargin, argilactam), neurotropic drugs (amihectone, tryptophane, nootricine); drugs acting upon the metabolic processes (hexaminate, osteocalcin);
  • immunotropic drugs (leuargunal, belims), antiinflammatory drugs (aceprol);
  • drugs for treatment of the gastrointestinal tract diseases (hepabel, hepvilag);
  • disintoxication drugs (belarg); drug for enteral tube feeding (enteral).

The development of the single- and polycomponent drugs for metabolic therapy and parenteral feeding is planned concurrently.

The implementation of the tasks of the State Scientific and Technological Programme “New Medicines” in the years 2006-2010 will make it possible to create the own production of pharmaceutic substances of all the irreplaceable amino acids and about 35 new highly efficient drugs intended for treatment and prophylaxis of the socially significant and other diseases in Belarus.
The financial resources to the amount of 39,826.2 million roubles, including 27,926.0 million roubles obtained from the republican budget are provided for implementation of the State Scientific and Technological Programme in the years 2006-2010.

The main social and economical effect expected from the implementation of the Programme consists in reduction of the import of a number of drugs and saving the monetary means in foreign currency the import substitution by 9 to 10 million US dollars annually and expansion of the export potential. It will make it possible to cover the budget expenses for the development of the new products within 4-5 years.
Within the framework of innovation projects to satisfy the state needs, the new-generation hemostatic and antianemic drugs will be created with introduction of them at Izotron Plant Republican Unitary Production Enterprise in the years 2008-2009.

As to the pathogenetic (anatomico-physiological) classification, the developed drugs are related to the groups:

  • cardiovascular drugs (hypotensive, antianginal, cardioprotector, antiatherosclerotic, angioprotector, disaggregant ones, etc.);
  • anticancer drugs; psycho- and neurotropic agents;
  • immunotropic, antiinflammatory and analgetic drugs;
  • metabolic correction drugs, infusion therapy, enteral and parenteral feeding;
  • bone-seeking and reparative drugs;
  • hepatoprotector and other drugs.

The prospects of development of the microbiological industry of the concern are related to the planned implementation of the State Scientific and Technological Programme “New Medicines” in the years 2006-2010 and organization of the small-capacity manufacture of the new kinds of biotechnological products according to the completed developments with the orientations to the needs of the Ministry of Agriculture Foods.

The production of such products as biological preparations for protecting the plants (bactogen, mycolin, frutin, baciturin, lignorin, pecilomycin, muscardin-L), biological fertilizers (rhizobacterin, phytostimophos), biologically active food additions (lentin and dialentin) and enzymatic agents for pharmaceutical, food and textile industry (celloviridin G2h, amylosubtilin G2h, amylorizin G20h, amyloglucavamorin G20h, pectinasa G20h, terrilitin) will be prepared and mastered at the enterprises of the branch.

This process provides for complex solution of such problems as stabilization of the financial and economical position and ensuring the solvency of the enterprises; technical re-equipment, reconstruction and modernization of the operating facilities; reducing the energy intensity and material intensity of the output products; introduction of resource- and energy-saving measures and ensuring the competitiveness of the output products.

The new kinds of drugs and biological preparation will be produced both at the operating facilities and at new ones to be created within the framework of the investment projects to be implemented in accordance with the long-term plan of innovative development for the years 2006-2010.

It is planned to elaborate the business plans, design estimates and implement the investment projects for creating the new pharmaceutical facilities in the regional centres Vitebsk and Mogilev, and accommodate the production of phytopreparations, phytoteas, medicinal teas, tinctures, etc. at the existing enterprises and new facilities in the city of Minsk and towns of Borisov, Drogichin and Lida. The reconstruction of the production of infusion solutions at Pharmland Joint Venture will be carried out at the cost of the foreign investments.

Within the framework of cooperation with Greenfield Company (Ireland), the possibility of construction of the enterprise for production of fuel ethanol with the capacity of 10 million dekalitres/year at Hydrolytic Plant Republican Unitary Enterprise (Bobruisk) for the purpose of deliveries to EU countries as additives to the engine fuels is considered.

The initial data for new products will be a basis for elaborating the design estimates for technical re-equipment, modernization, reconstruction and creation of new pharmaceutical and biotechnological production facilities of the Concern.

It is planned to allocate at least 30 per cent annually from the means of the branch innovative foundation for financing the scientific-and-technical and innovation activities, including the preparation and launching of the production of new kinds of products.

It is planned to provide for the further increase of the financial expenditure for the research activities firstly at the cost of attracting the off-budget sources with increasing the share of the means for preparing and launching the manufacture of the import-substituting products according to the completed designs. By the year 2010, the volume of financing the R&D works and those for preparing and launching of new kinds of science intensive products in Belbiopharm Concern will be about 7 billion roubles that will make it possible to increase the science intensity of the Concern’s products from 1.2 up to 1.8-2 per cent.

The scientific potential of the Concern consists of the four enterprises certified in 2001-2002 as branch scientific organizations, which perform the R&D works. They are Belmedpreparaty Scientific Pharmaceutical Centre Republican Unitary Enterprise, Dialek Scientific Research Centre Unitary Enterprise, MBI Research and Development Republican Unitary Enterprise and Lotios Unitary Enterprise.

At Borisov Medical Preparation Factory Republican Unitary Enterprise, Min-Skinterkaps Unitary Enterprise, Pharmland Joint Venture, there are structural subdivisions (teams) adapting the traditional or new technologies to the conditions of their own production jointly with the scientific institutions of the Republic.

The creation of the scientific and technical centres at the leading enterprises of the branch has given a powerful impulse in satisfying the needs of production for scientific workers. So, since the moment of creation of the ÍÔÖ (scientific and technical centres?) the nomenclature of the products manufactured by Belmedpreparaty Republican Unitary Enterprise has increased from 30 up to 300 items.

The average number of staff workers and employees of the organizations engaged in the R&D works and introduction of the development results is 345 persons in the branch including 29 candidates of science and 3 doctors of sciences. The “Staff” branch programme for the years 2006-2010 provides for training and retraining of specialists including the highest-qualification ones.

The provision of the branch with the highest-qualification scientific personnel will be replenished partially at the cost of interdepartmental scientific cooperation.

The activities of the branch centres are aimed mainly at the development of their founders that does not promote the internal technology transfer to the full extent. The functions of the parent organization for the State Scientific and Technological Programme are performed by the scientific institutions of the National Academy of Sciences of Belarus and Belarusian State University. For the purpose of further integration of the science with the production, coordination of the activities of the main centres with the academic and university science, planning and monitoring of the scientific and technical developments, rendering the consulting services and activation of the technology transfer, it is planned to centralize the scientific support of the long-term development of the Concern’s branches within a single organization (centre) subordinated to the Concern.

Integration of the academic, university and branch science with the production, its stimulation according to the end results of carrying out the innovation activities from the development idea to the sale of the products will make it possible to bring the new products to the world level.

To increase the prestige and efficiency of the intellectual and creative work and strengthen the scientific potential, it is proposed to improve the stimulation of the labour of the scientific workers for the development and introduction of the objects of new machinery and progressive highly efficient technologies.
In accordance with the legislation in force, it is planned to introduce the extra payments for scientific degree to the salaries of the workers having the degree of candidate or doctor of science and practising in the field of the respective scientific knowledge on the monthly basis.

For the purpose of motivation of achievement the efficient results of the work, it is planned to establish the extra payments to the salaries of the workers for the high creative and production achievements as well as complexity and intensity of work on the personal basis.

It is planned to apply the differentiation in the salary rates in the range allowing the labour of the most creative workers to be appreciated adequately.
To consolidate the most highly skilled personnel of the branch profile, the possibility of establishment of personal salary rates reflecting the contribution in the development of the advanced technologies of the national and branch priority in exceptional cases is considered.

The total amount of financing got creating the new enterprises and production facilities as well as for reconstruction and modernization of the operating enterprises in the years 2006-2010 will be 437,400 million roubles, including 346,500 million roubles at the cost of the Republican Budget’s funds, 42,800 million roubles from the bank credits and 48,100 million roubles from the own funds of the organizations.

 
1. Creation of new enterprises and top-priority productions
 
Br million
1.1 Create new pharmaceutical production in Vitebsk 2007—2010 90,000
1.2 Creation of production of solid dosage forms at
Borisov Medicine Plant RUE
2007—2010 91,000
1.3 Creation of joint venture for production of fuel-grade ethanol.
Hydrolysis Plant, Bobruisk RUE
2007—2009 104,400.0
1.4. Creation of joint venture for production of fuel-grade ethanol.
Etanol Mozyr Plant RUE
Mozyr
2008–2010 554,400.0
1.5 Creation of ointment production and suppositories production at
Belmedpreparaty RUE
2009 5,000
1.6 Creation of production of new medicine forms and plant-based preparations at Ekzon RUE 2009—2010 17,000
1.7 Creation of production of new medicine forms
Izotron Plant RUE
2007—2009 2,000
 
2 Creation of new productions at operating enterprises
 
Br million
2.1 Reconstruction of infusion solution production.
Nesvizh Medicine Plant RUE
2004–2008 24,000
2.2 Reconstruction and technical upgrade of pill production.
Belmedpreparaty RUE
2006—2008 7500
 
 
3 Modernization of existing productions on the basis of introduction of new and high technologies
 
Br million á
3.1 Reconstruction and technical upgrade of eye drops production with bottle-pack machine.
Belmedpreparaty RUE
2008–2009 9,000
3.2 Reconstruction of production of antineoplastic drugs in form of lyophilized powders and injection solutions.
Belmedpreparaty RUE
2008–2010 34,000
3.3 Reconstruction and technical upgrade of production of sterile filling of medicines into glass bulbs and flasks with subsequent lyophilization.
Belmedpreparaty RUE
2008–2009 21,000
3.4 Technical upgrade of production of animal substances (chondroitin sulfate).
Belmedpreparaty RUE
2008–2010 7,000
3.5 Technical upgrade of medicine production.
Minskinterkaps PRUE
2007—2010 9,000
3.6 Reconstruction and technical upgrade of medicine production.
Pharmland JV LLC
2007—2010 2,400
3.7 Organization of production of maize starch, dextrose monohydrate and products on basis of syRUEand glucose.
Ekzon-Glukoza RUPE, Drogichin
2007—2010 17,250
 
 
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