Development of contract manufacturing on the example PJSC «Pharmimex»

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1 Development of contract manufacturing on the example PJSC «Pharmimex» Inga Aleksandrovna NIZHARADZE, Vice-President of PJSC «Pharmimex» +7 (495) (49156)

2 Localization of production in Russia as a priority of international manufacturers In the last 10 years, the Russian pharmaceutical market remains one of the priority directions of development for many international companies. The main reason for this attention is the rate of growth of the Russian pharmaceutical market. (Thus, according to AMRO Pharmexpert in the period from 2005 to 2010, this increase amounted to RUB 304,1 billion or 130,2%.) Such divergent factors as a significant market growth rate (on average, 21% per year) on the one hand and the global financial crisis of and the dependence on imported medicines (about 80% in rubles) on the other hand are the reasons for import substitution course (as the original global phase) and the innovative development of the domestic pharmaceutical industry (as a follow-up to global phase) [The Pharma 2020 strategy; FSPP Development of pharmaceutical and medical industry in the Russian Federation on the period until 2020 and for the further perspective and the order of the Ministry of Economic Development of the Russian Federation No. 427 dd December 5, 2008 (15% preference)] 2

3 Motivation of the international manufacturers to localize production in Russia Reasons for international manufacturers to consider the possibility of localization in Russia together with the Russian partner: Further projected market growth (long term growth of 8.1% / IMS Health) Specification of requirements for locally-produced medicines and preferences in public procurement. The necessity of localization of medicines with expiring patent protection (the third wheel (третий лишний) program). The potential threat of the introduction of compulsory licensing in Russia. Access to the markets of Eurasian Union Low probability of appearance of production sites of the international companies built from scratch, and focus on contract manufacturing: Smaller, compared to own production, capital expenditures; The presence at hand other than purely technical competences of the partner (registration, marketing, etc.). 3

4 Motivation of the international manufacturers to localize production in Russia Additional arguments of localizing the contract production at Russian enterprises: Cheap labor ( Vedomosti : The cost of labor in Russia is even lower than in China ) Cheap energy (electricity, gas) Modern production facilities, meeting the standards of GMP Professional, well educated personnel with extensive experience of fulfillment of contractual orders. High quality of intellectual property protection at the state level. 4

5 Risk factors of localization of production in Russia for international manufacturers Factors that may force international companies to make a decision on the refusal of localization on the Russian capacity: Possible introduction of the international principle of exhaustion of exclusive rights for the products, i.e., parallel (grey) imports. The ongoing uncertainty with measures to support locally-produced medicines. The company's decision on the localization on one of the other markets of the Eurasian Union (this is most true for Kazakhstan). 5

6 PJSC «Pharmimex» Essential medicines should be available to everyone PJSC «Pharmimex» is among the three largest pharmaceutical distributors on the Russian state procurement market with a share of 6.39% and with a turnover of around 30 billion rubles a year. (Remedium, 2015) Participation in federal programs: 7 Nosologies. Supplies of drugs for the treatment of hemophilia, multiple sclerosis and Gaucher disease. National Immunization Calendar. Supplies of vaccines to prevent polio and Haemophilus influenzae. Prevention and treatment of HIV. Delivery Program the treatment of HIV-positive patients. Essential drugs (ONLS) program. Provision of medicines to the citizens of preferential categories in 16 subjects of the Russian Federation. Treatment of rare (orphan) diseases. PJSC «Pharmimex» supplies medicines for the treatment of 14 of the 24 life-threatening and chronic progressive rare (orphan) diseases, leading to reduced life expectancy of citizens or their disability. 6

7 «Skopinpharm» Ltd. Since 2013 PJSC «Pharmimex» group of companies includes production enterprise Skopinpharm Ltd. a modern, dynamically developing Russian pharmaceutical company, manufacturer of medicines. Originally designed and built meeting the requirements of GMP. Russia, Ryazan region, Skopinsky district 270 km from Moscow In June 2015 the construction of a biotech corps Blood products with physical-chemical laboratory area of 1000 m 2 for the production of 4 stages of blood products (secondary viral inactivation, labelling of bottles, secondary packaging, quality control) was complete. The modernization of the case of the production of solid dosage forms was complete. The production capacities which allow to produce 1,2 billion capsules/tablets per year in two-shift operation was put into operation. 7

General plant development plan Draft master plan for development of pharmaceutical production of OOO Skopinpharm, M 1:500 Explication of buildings and structures 1.

8 General plant development plan Draft master plan for development of pharmaceutical production of OOO Skopinpharm, M 1:500 Explication of buildings and structures 1. Existing 2-story industrial building 2. Existing 1-story warehouse building 3. Existing 2-story production and warehouse non-residential building 4. Projected non-residential building albumin production 5. Projected non-residential office building with a meeting room and a canteen 6. Projected non-residential security checkpoint building 7. Projected complex of utility premises for personnel 8. Projected non-residential industrial building for the production of finished forms lyophilization and pre-filled syringes 9. Projected non-residential industrial building for the production of substances of recombinant proteins and monoclonal antibodies 10.Projected non-residential industrial building for the production of cytostatics 11.Projected corridor system of inter-production connections 12.Projected garage box with workshops for factory vehicles 13.Projected package transformer substation and rooms for diesel generators for power supply of production complex 14.Projected boiler building for industrial complex 15.Projected building for pumping and water purification for industrial complex 16.Existing water well for special water use 17.Existing structures of septic tank 18.Existing underground fire tank for water storage and fire fighting 19.Projected structures of septic tank 8

Compliance with modern quality standards PJSC «Pharmimex»: License of Roszdravnadzor for

of health care for activities of trafficking in narcotic drugs, psychotropic substances and their

Certificate of GOST ISO 9001-2011 (ISO 9001:2008) in relation to the wholesale and retail trade of

: License of the MINISTRY OF INDUSTRY AND TRADE of the Russian Federation on the implementation of

LETTER OF COMPLIANCE with the requirements of GMP rules of organizing the manufacturing and quality

2016 Certificates of QMS requirements of ISO 9001:2008 and GOST R ISO 9001-2011 16.1251.026 from 23.

9 Compliance with modern quality standards PJSC «Pharmimex»: License of Roszdravnadzor for pharmaceutical activities on May 24, 2012 FS License of Roszdravnadzor in the sphere of health care for activities of trafficking in narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants from April 17, 2014 FS Certificate of GOST ISO (ISO 9001:2008) in relation to the wholesale and retail trade of pharmaceutical and medical goods, manufacturing, storage and warehousing... «Skopinpharm» Ltd.: License of the MINISTRY OF INDUSTRY AND TRADE of the Russian Federation on the implementation of pharmaceuticals production No LS dd July 26, LETTER OF COMPLIANCE with the requirements of GMP rules of organizing the manufacturing and quality control of medicines. No. GMP /16 dd Certificates of QMS requirements of ISO 9001:2008 and GOST R ISO from and from in relation to the production and supply of blood products, solid finished drugs (tablets, capsules) issued by the certification Association "Russian register" by results of check 9

10 Motivation of PJSC «Pharmimex» to attract contract customers Since 1997 PJSC «Pharmimex» is one of the key suppliers of medicines in the sphere of public procurement. The main products of our portfolio: modern innovative medicines for the treatment of primarily severe orphan diseases. The manufacturing of own portfolio medicines Small amount. High-tech. High cost price. Contract manufacturing Large amount => Capacity utilization Reducing the cost of production Providing of the available innovative medicines to the population of the Russian Federation 10

11 PJSC «Pharmimex» own R&D PJSC «Pharmimex» continues its successful cooperation with scientific research centers for development of new medicines: therapeutic monoclonal antibodies (2 molecules in R&D) and medicines for the treatment of cardiovascular diseases (2 molecules in R&D). Our strategy is in development of new products or localization (technology transfer) of drugs, which have great demand and are widely used for the treatment of patients in the Russian Federation. Erythropoietin PJSC «Pharmimex» together with FSUE GosNII OChB of the Russian FMBA have developed high-yielding rubber stamp-producer of recombinant Erythropoietin, which is patented in the Russian Federation. The specific biological activity as high as possible. All the technology of production of Erythropoietin corresponds to the European Pharmacopoeia. The received stamp producer allows to achieve the most cost-effective production in high yield of active substance. The Pharmimex company plans to carry out the registration of the Erythropoietin medicine in Europe for its sale. The medicine is widely used in anemia especially for patients with chronic renal failure. 11

12 How does Russia benefit from contract manufacturing? Technology transfer The creation of new modern technological platforms and infrastructure Training and transfer of best practices New level staff 12

UNICEF Quality Assurance in the procurement of medicines

UNICEF Quality Assurance in the procurement of medicines Peter S. Jakobsen 30 October 2006 Quality Assurance Centre SUPPLY DIVISION Today s presentation addresses 3 questions: How is UNICEF involved in