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Vladimir Krasnikov_April 22 2015_CPhI Tokyo

  1. 1. Increasing Market Opportunities in the Emerging Russia as its’ Powerhouse Vladimir Krasnikov, Director General RUSSIAN PHARMALICENSING GROUP Creating a safer environment by bridging business culture gaps Tokyo, April 22, 2015
  2. 2. Welcome CPhI-Japan 2015, the comprehensive pharmaceutical event bringing together leaders and key decision makers from Asian and the global pharmaceutical industry in Tokyo Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  3. 3. Session 1 15:00 – 15:25 Introduction • About Russian Pharmalicensing Group (RPhG) • Japan-USSR/Russia: The history of the business relationship • Japan-Russia: "Sanctions? Business is above all“ • Japanese drugs (FDF) and nutritional supplements (FDF) market in Russia, 2004-2014. API of Japanese origin in the Russian market Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  4. 4. About RPhG(1) Company Information • Business Name: Russian Pharmalicesensing Group LLC (RPhG) • HQ: Moscow • Markets: Russia, ex-USSR countries, West Africa • Established: 2007 Company Overview Supporting foreign innovators or licensors entering the Russian pharmaceutical, biotech, food supplement and medical devices markets by means of marketing their licensing opportunities among decision- makers in Russia and the ex-USSR territory by bringing buyers and sellers together. We can help foreign company to register their products and identify a rightpartner/marketer in Russia. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  5. 5. About RPhG(2) General Business Activities • BD&L (Business development and licensing) • Regulatory affairs incl. clinical trials • M&A advisory services Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  6. 6. Creating a safer environment by bridging business culture gaps Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  7. 7. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  8. 8. Russian foreign trade partners Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Rating Country Volume, billion USD Jan-Nov 2014 Increased in turnover as compared with Jan-Nov 2013 1 China 81.1 101.5% 2 Netherlands 67.9 97.7% 3 Germany 64.2 94.8% 4 Italy 45.0 92.8% 5 Turkey 28.5% 97.4% 6 Japan 28.3% 93.8% 7 USA 27.0% 107.5% 8 S.Korea 25.5% 111.2% 9 Poland 21.6% 86.0% 10 UK 18.2% 82.1% Source: Federal Customs Service of Russia
  9. 9. Japan-USSR: The history of the business relationship • In 1957, the total amount of trade turnover between the USSR and Japan was only 21.6 million $ • In 1963 it increased to 320 million $ 15-fold increase within 6 years! Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  10. 10. Japan-Russia: "Sanctions? Business is above all“ Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  11. 11. Size and dynamics of retail pharmaceutical market of leading countries in 2012, bln $ 0 50 100 150 200 250 USA Japan China Germany France Brazil Russia Canada Italy UK +21% +10% +16% Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Source: DSM Group, Russia
  12. 12. Big Pharma Boys Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  13. 13. Astellas and Takeda wholesales in Russia, 2004-2014 Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 ASTELLAS PHARMA* 43 422 177 57 059 655 105 524 150 122 643 401 159 274 988 163 230 240 205 426 608 254 968 304 297 523 412 308 895 525 285 536 284 NYCOMED/TAKEDA 102 484 138 163 042 314 200 924 659 265 501 778 356 132 586 369 719 218 452 110 924 549 864 996 571 776 578 604 894 752 588 583 078 0 100 000 000 200 000 000 300 000 000 400 000 000 500 000 000 600 000 000 700 000 000 USD Source: IMS Healthcare, Russia
  14. 14. Astellas and Takeda retail sales in Russia, 2010-2015 Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Source: IMS Healthcare, Russia 2010 2011 2012 2013 2014 YTD/2015/ MTH02 NYCOMED/TAKEDA 354 370 646 428 083 753 449 423 475 496 460 201 482 283 239 52 063 078 ASTELLAS PHARMA* 170 427 342 208 045 303 240 817 677 256 207 525 236 166 947 26 978 152 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% USD
  15. 15. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Source: IMS Healthcare, Russia Astellas and Takeda hospital sales in Russia, 2010-2015 2010 2011 2012 2013 2014 YTD/2015/ MTH02 NYCOMED/TAKEDA 64 853 604 85 563 045 114 901 352 101 618 785 101 419 930 5 570 525 ASTELLAS PHARMA* 5 883 038 16 629 644 25 941 478 31 405 955 33 510 926 1 885 170 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% USD
  16. 16. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Source: IMS Healthcare, Russia Astellas and Takeda state procurement sales in Russia, 2010-2015 2010 2011 2012 2013 2014 YTD/2015/ MTH02 NYCOMED/TAKEDA 32 886 674 36 218 197 7 451 751 6 815 766 4 879 909 764 412 ASTELLAS PHARMA* 29 116 228 30 293 357 30 764 257 21 282 045 15 858 411 4 532 742 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% USD
  17. 17. Japanese origin drugs (FDF) manufacturers market in Russia, USD 701 564 953 630 2 738 238 2 358 399 4 665 755 2 904 785 4 307 748 5 812 633 7 843 290 6 447 368 4 081 189 0 1 000 000 2 000 000 3 000 000 4 000 000 5 000 000 6 000 000 7 000 000 8 000 000 9 000 000 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Source: IMS Healthcare, Russia
  18. 18. Japanese drugs manufacturers in the Russian market Manufacturers ATC3 product categories 1. A05B 2. G02 3. L01A 4. L01B 5. L01C 6. L01D 7. L01W 8. N03A 9. S01X Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 1. Biken 2. Daiichi Pharm 3. Japan Biopro. Inds. 4. Kyowa 5. Melsmon Pharm 6. Nippon Kayako 7. Sandzu Pharma 8. Sankyo 9. Taiho Pharma
  19. 19. Japanese API manufacturers in the Russian market 1. Yuki Kase Kogyo Ko.Ltd 2. Shin-Yo CO., LTD 3. Biochem Corporation 4. SMIC SMO Ko.Ltd 5. Kaneka Corporation 6. Ajinomoto Ko.Ink 7. Ionezava Hamari Chemicals ltd. Japan 8. Dayita Corporation Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Japanese 20 APIs have been registered in Russia
  20. 20. Japanese nutritional supplement (FDF) market in Russia, USD Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Source: IMS Healthcare, Russia 103 849 119 771 179 504 360 111 508 507 2 423 054 1 058 4741 048 112 266 478 2 251 887 2 449 616 0 500 000 1 000 000 1 500 000 2 000 000 2 500 000 3 000 000 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Source: IMS Healthcare, Russia
  21. 21. Japanese nutritional supplements manufacturers in the Russian market 1. Arkray 2. B2UP Co Ltd 3. Cross Co Ltd 4. Daiwa Pharm 5. Orihido Co 6. Osato Res. Inst. 7. Paladium Corp 8. Pharmaspray 9. Shimizu Chemical 10. Yanako Co Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  22. 22. Kyorin Pharmaceutical and R-Pharm Reach Agreement in Russia • In October 2014, Kyorin Pharmaceutical and R-Pharm Reach Agreement in Russia and neighboring nations for Activities Related to the Development and Marketing of Imidafenacin • Kyorin Pharmaceutical grants R-Pharm exclusive rights to activities related to the development and marketing of Imidafenacin in Russia and neighboring nations. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  23. 23. Session 2 15:25 – 15:35 Healthcare in Russia. Segments of the Russian pharmaceutical market • Healthcare in Russia at a glance • Russian pharma industry outlook 2014 • Russian pharma market at a glance • Commercial (retail), Parapharmaceuticals, Hospital and State Procurement Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  24. 24. RUSSIAN HEALTHCARE AT A GLANCE Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  25. 25. Indicator Data Share of expenses on healthcare in Russian GDP 3.7% Forecast of healthcare financing in 2018 4.5% GDP Expenses for healthcare in absolute figures in Russia 2.4 trillion rubles (equal to 53.5 billion euros) Healthcare expenses per capita 22,000 rubles (equal to 490 euros) Life expectancy Total: 66.25 years For men: 63.5 years (80 years in Japan)* For women: 69 years (87 years in Japan)* Healthcare infrastructure 5,000 state hospitals + 12,000 polyclinics Less than 300 private clinic Healthcare regulator Ministry of Healthcare of the Russian Federation Minister of Healthcare Professor Veronika Skvortsova Healthcare in Russia, 2013 Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Sources: Russian MoH; *WHO Statistics 2014
  26. 26. Russian Pharma Industry Outlook 2014 The industry, the number of new enterprises, their percentage of the total number of new enterprises. • Food industry and Agriculture: 100 (28%) • Construction industry: 85 (23.8%) • Mechanical engineering and metallurgy: 47 (13.2%) • Petroleum and petrochemical industry: 26 (7.3%) • Pharmaceutical industry: 18 (5%) • Automotive: 28 (7.8%) • Mining: 8 (2.2%) • Light industry: 15 (4.2%) • Radio Engineering and Electrical: 30 (8.4%) Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Source: President's Council on economic modernization and innovative development of Russia.
  27. 27. Size and Dynamics of Retail Pharmaceutical Market of Leading Countries in 2012, bln $ 0 50 100 150 200 250 USA Japan China Germany France Brazil Russia Canada Italy UK +21% +10% +16% Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Source: DSM Group, Russia
  28. 28. Russian Pharma Market at a Glance • Russia contributes only 0.2% of the world’s supply of pharmaceuticals • Pharma market is dominated by imported drugs (up to 75%) in value (USD) and 45% in volume (units) • Up to 70% of the pharmaceutical products are financed out-of-pocket by patients • The existing state reimbursement system covers around 20% of medication costs and guarantees free drug provision only to certain vulnerable groups of patients Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  29. 29. Ratio of the sales volume of Rx and OTC in 2014 Value-wise (RUR) Volume-wise (units) 50% 50% Rx OTC 29% 71% Rx OTC Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Source: DSM Group, Russia
  30. 30. Segments in the Russian Pharma Market Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Commercial (retail) 59% Parapharmaceuticals 16% State procurerement 7% Hospital 18% Source: DSM Group, Russia
  31. 31. The Russian Pharma Market by Segments in 2013-2014 Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 2013y 2014y Growth TOTAL, USD 32 782 351$ 25 969 818$ -20,8% TOTAL, RUBLE 1 045 757 000 ₽ 1 142 672 000 ₽ 9,3% q1-4 2013 q1-4 2014 q1-4 2013 q1-4 2014 Commercial (retail) 608 841 674 710 10,80% 4 422 4 223 -4,50% Parapharmaceuticals 169 404 182 956 8,00% State procurement 84 829 84 056 -0,90% 75 70 -7,60% Hospital 182 682 200 951 10,00% 957 967 1,00% TOTAL 1 045 757 1 142 672 9,30% 5 455 5 259 -3,60% Segm ent Volum e, billion rubles Growth Volum e, m illion units Growth Source: DSM Group, Russia
  32. 32. Russian Pharma Market by ATC, 2014 Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Source: DSM Group, Russia A: Alimentary tract and metabolism 19,30% 17,80% R: Drugs for the treatment of diseases of the respiratory system 12,70% 14,30% C: Cardio 12,30% 10,30% N: Neurology 11,80% 18,50% M: Drugs for the treatment of diseases of the musculoskeletal system 7,70% 6,70% D: Derma 6,10% 10,40% L: Antineoplastic and immunomodulating agents 4,20% 1,80% B: Blood agents 3,40% 2,90% [~] Drugs w/o ATC 3,20% 5,00% S: Drugs for the treatment of diseases of the sense organs 2,60% 2,40% V: Others 0,60% 0,50% P: Antiparasitic products, insecticides and repellents 0,30% 0,50% АТС Groups (1st level) MS (value), % MS (volume), units, % J: Anti-infectives for systemic use 7,70% 6,50% G: Drugs for the treatment of diseases of urogenital bodies and sex hormones H: Hormonal drugs systemic use (excluding sex hormones) 7,40% 1,90% 0,60% 0,60%
  33. 33. Top 10 distributors in the Russian pharmaceutical market (FDFs) RATING 2013y DISTRIBUTOR VALUE MS, % VALUE INCREASE, % RUR, BLN €, BLN 1 Katren 137,1 3,05 16,2 22,6 2 Protek 133,2 2,96 15,7 8,4 3 ROSTA 93,8 2,08 11,1 14,3 4 SIA 83,7 1,86 9,9 -6,9 5 R-Pharm 62,6 1,4 7,4 26,9 6 Alliance Healthcare 61,6 1,37 7,3 5,3 7 Pulse 49,5 1,1 5,8 38,8 8 Oriola 40,5 0,9 4,8 8,2 9 BSS 21,2 0,47 2,5 35,2 10 Imperia Pharm 14,1 0,31 1,7 -13,9 Top 10 distributors account for more than 80% of sales with a trend of consolidation Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Source: DSM Group, Russia
  34. 34. Peculiarities of the top Russian pharmaceutical distributors • Business diversification: 1. Almost all national distributors have a subordinate network of pharmacies (Protek, Katren, Rosta, Oriola, etc.) within the control structure 2. Developing actively is its own production (Protek with Sotex, R-Pharm, SIA, Biotec etc.) Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  35. 35. Rating of pharmacy chains at the end of 2014 Rating Pharmacy chains Volume, billion rubles Share in commercial segment, Increased in turnover as compared with Number of sales outlets 4 qt., 2014 4 qt., 2013 1 A.V.E. * (incl. 36,6) 8.2 3.2% 13% 709 2 Rigla 8.1 3.2% 29% 1 202 3 Implosia 6.2 2.4% 18% 1 350 4 А5 5.6 2.2% 23% 1 005 5 Doctor Stoletov (incl. Ozerki) 5.4 2.1% 16% 342 6 Raduga (incl. Pervaya Pomoshch) 3.9 1.5% -3% 866 7 Pharmaimpex 3.4 1.3% 7% 534 8 Pharmland 3.3 1.3% 66% 485 9 Planeta Zdorovo 3.1 1.2% 37% 635 10 Samson-Pharma 2.4 1.0% 53% 41 11 Vita 2.4 1.0% 11% 457 12 Klassika 2.3 0.9% 2% 178 13 Pharmacor 1.9 0.8% 16% 380 14 Ladushka 1.8 0.7% 21% 225 15 Melodiya Zdorovya 1.7 0.7% 19% 520 TOP-15 59.7 23.4% 19.4% 8 929 Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015 Source: DSM Group, Russia
  36. 36. Session 3 15:35 – 16:00 Regulatory Affairs • The categories of medicinal products subject to the state registration • Drug registration procedure • State registration (listing in the Register) of APIs in Russia • Medical device registration in Russia Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  37. 37. The categories of medicinal products are subject to the state registration 1. Original medicinal products 2. Generic medicinal products 3. New combinations of the previously registered medicinal products 4. New pharmaceutical forms and dosages of the previously registered medicinal products Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  38. 38. Drug registration procedure in Russia Principles of medicinal product expertise and ethical expertise • The process consists of 2 stages: 1. Procedures for obtaining authorization to conduct a clinical 2. Procedures for examination of the quality, effectiveness Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  39. 39. Stages of registration of pharmaceutical products and medicines in Russia 1. The study of the documentation 2. Consultations with experts of the executive bodies; signing of the contracts 3. Pre-registration documentation scope 4. Pharmaceutical expertise 5. Clinical trials (individually) 6. Registration certificate issuing Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  40. 40. Preclinical studies of generics in Russia • Definition of general toxic properties (acute and sub acute (sub chronic) toxicity • Local irritant effects when compared with the registered analogue Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  41. 41. Preclinical studies for the original drugs and biosimilars • Overall assessment of general toxic properties • Specific types of toxicity (mutagenicity, reproductive toxicity, carcinogenic effects, allergenic effects, immunotoxin effects) • Pharmacological security • Specific pharmacological activity • Pharmacokinetics Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  42. 42. Article 14 of the Federal Law No.61 “On circulation of medical products” Article 14. Principles of medicinal product expertise and ethical expertise 1. Expertise of medicinal products and ethical expertise are based on the principles of legality, respect for the rights and liberties of an individual and citizen, rights of legal persons, independence of an expert, objectivity, comprehensiveness and completeness of trials conducted with the use of modern achievements in science and technology, responsibility of a federal state budgetary institution for conducting expertise of medicinal products and of experts for the expertise conduct and quality. 2. Expertise of medicinal products for medical use is conducted in stages: 1) at the first stage – expertise of documents for obtaining authorization to conduct clinical trials of a medicinal product, except for: а) medicinal products which have been authorized for medical use in the Russian Federation for more than twenty years and in regard to which it is impossible to conduct bioequivalence trial; б) medicinal products for medical use, in regard to which international multicenter clinical trials are conducted, a part of which is carried out in the Russian Federation; Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  43. 43. Clinical trials in FL No.61 BEFORE Law enactment Registration scheme in general conformed to international approach AFTER Law enactment Unique registration scheme is created which has no parallel: • Mandatory local trial conduct • Results of MICT (Multicenter International Clinical Trials) are not recognized unless Russian centers participated therein Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  44. 44. 45 State registration (listing in the Register) of APIs in Russia Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  45. 45. Formulations and APIs registration in Russia. Issues and handling. 1. A registration of API is actually is listing in the State Registry 2. Listing of API is relatevely a long term process and it has kept becoming significantly more complicated and austere since 2010 as a result of the following: – Russia joining WTO; – Strengthening of regulatory authorities' role as a watchdog of Russian people's safety; – Extension of conditions for clinical trials to new drug applications and as the consequence to quality of API; – Russian Government's active involvement in pharma business regulation, including pricing of life saving drugs, tender business, support of Russian manufacturers (Pharma 2020), focusing on tech transfer instead of finished drugs imports. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  46. 46. API listing in the Registry. Key Aspects (1). 1. A registration dossier is submitted to the Russian Health Ministry. 2. Within 5 to 10 days, the Health Ministry reviews a dossier, and in case no questions arised, it issues a request for a quality test. 3. Upon receipt of a quality test request, within 15 days, samples of the API, a reference standard sample, and other standard samples (if used for raw materials control) should be submitted to the Federal Agency for Medical Substances Testing and Certification. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  47. 47. API listing in Register. Key Aspects (2). 4. API quality testing lasts for 60 working days. 5. Results of the testing are forwarded to the Health Ministry, and, within 10 working days, the Health Ministry reviews the results and forwards an unquiry featuring the results of testing to the company-manufacturer. (The inquiry should be replied within 7 days). 6. Upon receipt of a response to the inquiry, should no issues are raised, regulation documentation and a draft decision for filing the API in the State Registry is prepared (registration papers for a substance are not handed out at this time). Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  48. 48. API listing peculiarities (1). 1. According to law, API registration process lasts for 110 working days, but currenly timelines are not complied with, and an applicant should expect a 8-12 month period, provided a quality test yields a positive outcome. 2. The official state duty for API registration is 100,000 Roubles (equal to 2,800$ or 2,100€), no more official payments on top of that are due. 3. As far as a patent is concerned, an API patent as such is not submitted with a registration dossier, but there must be a document certifying the manufacturing of this substance issued by a manufacturer (a GMP certificate and a copy of manufacturer's license). Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  49. 49. API listing peculiarities (2). 4. It is known that in the EU and the USA API manufacturers do not register pharmaceutical substances separately from the finished product. It is different in Russia: first, the API manufacturer register a pharmaceutical substance, while FDF registration should be done by FDF manufacturer. Thereby, no registration-no business as Russian manufacturers are not interested in non registered product discussion. Technically, for registartion our company needs only the section 3.1.S - 3.7.S, i.e. only the part that concerns the substance, to register the pharmaceutical substance. We also require the annexes concerning validation of analytical methods if they are not pharmacopoeias. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  50. 50. Documents and data required for the preparing of registration dossier for API of foreign origin in Russia. I. Administrative documents of the manufacturer of pharmaceutical substances. 1. Power of Attorney from the manufacturer to the applicant (required legalization).* 2. Documents confirming the registration of API, if registered outside the Russian Federation (Manufacturing License).* II. Documents on the production. 3. Documents conforming of compliance with the conditions of production, national or international standards (legalization required)*. 4. A brief outline of the production process and methods of process control. 5. Description of the stages of production control. 6. Description of quality control of finished substance, specification, validation of analytical methods, validation and / or qualification process. 7. Information about the conditions of storage and transportation of the drug. 8. Certificate in substance from the manufacturer. 9. Specification packaging materials. *Documents must be notarized in the country of manufacture. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  51. 51. Medical devices registration in Russia Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  52. 52. Medical devices market in Russia • Medical devices market values 4,2 bln USD in Russia in 2013 • Top 4 medical devices county origin ranks as 1. China 2. USA 3. EU 4. Russia Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  53. 53. Peculiarities of Medical Devices Registration in Russia (1) • Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) follows hazard classification of medical devices aren't harmonized with the international norms and standards. • An artificial barrier initially intended to wall off careless producers eventually create problems for the regulation and procedural support of medical devices registration in Russia. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  54. 54. List of Documents Required for Applying of Registration of Medical Products of Foreign Origin in Russia 1. Letter of Manufacturing Organization – 1 copy. 2. Letter of Attorney given to an authorized person by Manufacturing Organization/MAH for carrying out registration. 3. Application for Registration, Re-registration of a Medical Product (in Russian) – 2 copies. 4. Certificate of a Medical Product with the brief information about its application and main characteristics (in Russian) – 2 copies. 5. Photographs of a Medical Product (size not less than 130*180 mm) – 2 copies. 6. Promotional illustrative material – 2 copies. 7. Registration documents of Manufacturing Organization in the country of origin and/or in other countries – 2 copies. 8. Registration documents of a Medical Product as a measuring device in the country of Manufacturing Organization/MAH and/or in other countries (if available) – 2 copies. 9. Foreign documents (national or international), confirming the compliance of a Medical Product with the requirements of national or international regulative documents and characterizing conditions of its production. – 2 copies. 10. Application data sheet/operating instruction of Manufacturing Organization/MAH for a Medical Product (in Russian) – 2 copies.
  55. 55. Requirements to Legalization Procedure of Documents Necessary for the Solution of a Question of Registration of Medical Products of Foreign Origin • The documents submitted to the Federal Service on the Supervision in the public health and social security sphere for consideration of a question of registration of a Medical Product and issue of the corresponding certificate are to meet the requirements as follows: 1. A letter of Manufacturing Organization stating the intention to perform registration of products is to be presented on a letterhead paper in the official language of the Manufacturing Organization with the translation into Russian. 2. Application for Registration, Re-registration of a Medical Product is to be presented on Applicant’s letterhead paper, according to form indicated in Annex 2, and if required to provide full and correct information on the complete of the Medical Product to be registered. Application is to be presented in Russian or with Russian translation. 3. A letter of Attorney granting the right to perform registration is to be arranged and certified in accordance with established order. 4. Certificate of a Medical Product is to include brief information about its application, main characteristics as well as information of the time of its development, launching and the countries it is supplied to. It is to be presented in Russian or with Russian translation. 5. A photograph of a Medical Product is to represent the appearance of a product and its components. 6. Promotional illustrative material is allowed to be submitted in a foreign language. 7. Documents mentioned in clauses 7, 8, 9 of “List of Documents Required for Applying of Registration of Medical Products of Foreign Origin in Russia” if Annex 1 are to be presented in the original or copies certified in the established order. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  56. 56. www.RegulatoryAffairs.RU Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  57. 57. Session 4 16:00 – 16:15 Entry to The Russian Pharma Market • BD strategy for existing Russian pharmaceutical market members • BD strategy for beginners of Russian pharmaceutical market members • M&A. Regional Insights Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  58. 58. Market Access RPhG can make assessment and test your product against competing ones in the Russian market Build a winning value proposition of your product that can be tailored to the decision- maker in Russia Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  59. 59. Business development strategy
  60. 60. Business development strategy 1. BD strategy for existing Russian pharmaceutical market members 2. BD strategy for beginners of Russian pharmaceutical market members Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  61. 61. BD strategy for existing Russian pharmaceutical market members 1. Building of new manufacturing facilities on the Russian Federation territory 2. Purchase of the existing manufacturing facilities 3. Creation of cooperative management enterprise with Russian (foreign) manufacturer including contract manufacturing (i.e. localization) 4. Russian market launch of new medicinal products 5. No significant changes Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  62. 62. Localization 1. The key factor in the state strategy “Pharma 2020” 2. Localization of pharmaceutical production – a complex process 3. Total volume of investments in the Russian pharmaceutical industry in a variety of localization forms has already exceeded 1.6 billion dollars, and there is more to come. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  63. 63. Key issue facing foreign companies towards localization in Russia a) Establish its own manufacture or b) Use local sites Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  64. 64. Construction of its own manufacture PROS • Full control and management • Quality Control • Control over all stages of manufacture: – FPP manufacture – Manufacture quality control – Primary Packaging – Secondary packaging • Rapid technology transfer • Not subject to external political and economic factors, including sanctions • Cost reduction; imported medicinal products are subject to 10% tax duty in Russia • Tax incentives from the state CONS • Large investments • Start of production requires 3 and more years • Lack of qualified personnel (technicians, production managers) and, as a consequence, its high cost Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  65. 65. Services of local manufacturers PROS • Relative project completion progress • Low cost of entry • Ability to attach an additional site CONS • Lack of complete control over all stages of manufacture • Access to appropriate technology • Limited capacity of local manufacturers for high-tech product manufacture Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  66. 66. Sotex profile • Sotex is a leading Russian R&D company • High-tech production site with the requirements GMP EU • R&D platform with competencies in development of injectables and biotechnological products • Unique line for the production of drugs in pre-filled syringes with automatic needle protection Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  67. 67. Sotex Partners Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  68. 68. BD strategy for beginners of Russian pharmaceutical market members 1. Independent entry into the market 2. Purchase of the Russian company or establishment of cooperative management enterprise 3. Authorization of in home medicinal products with the following out-licensing 4. Selling of authorization dossier including contract manufacturing Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  69. 69. M&A. Regional Insights “The pharmaceuticals and biotechnology sectors are currently battling with declining pipelines, patent expirations and a clampdown on healthcare spending. As their troubles grow, the sectors are being forced to increasingly engage in mergers and acquisitions (M&A) activity.” Global M&A: Outlook for Pharmaceuticals. KMPG • Many global companies seeking to establish a foot print here in Russia due to good economic climate and consistent pharma market annual growth of 10%-12% since 2003. • National Health Project funds, Biopharma clusters and GMP plants drive Russian’s Pharma 2020 • The level of M&A activity for the past years in Russia has been consistent – between 8-10 deals per year • Most of the transactions were driven by acquirer’s need to access to pipeline and products, and with entering to Russian market • There are actually mid size transactions Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  70. 70. Nycomed invested in pharma plant in Russia 2006. Nycomed is ranked 9th among TOP-10 pharma companies in Russia 2009. Takeda-Nycomed announced to invest 75 mln euro in building of manufacturing plant in Yaroslavl, Russia. 2010. Vladimir Putin groundbreaked ceremony of the future plant took place Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  71. 71. Pharmstandard and Millhouse to take stake in Russian Biocad in 2014 • Biocad a biosimilar developer produces original biological products as well as generic biotech drugs • 130 employees of BIOCAD are involved in the creation and study of new drugs Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  72. 72. AstraZeneca • In 2011, Innovative Development Agency (AIRCO) has begun construction of its own full cycle plant to transfer manufacture of about 30 AstraZeneca drugs • AstraZeneca constructs a plant in accordance with international standards • Total investment in the construction of the plant will be about $ 187 million, of which the second phase will have more than $ 100 million. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  73. 73. Kaluga Industrial Park “Grabtsevo” added a new Berlin-Chemie Plant • A Berlin-Chemie plant—Berlin Pharma—was opened on May 19, 2014 in the industrial park “Grabtsevo” • The total investment into the project was approximately EUR 30 million Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  74. 74. Abbott agreed to buy Veropharm in 2014 • Abbott acquired a Russian drug maker Veropharm for 17 billion rubles ($ 495 million) • Abbott also incurs the Veropharm debts in the amount of 4.7 billion rubles ($ 136 mln) Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  75. 75. Novo Nordisk opens new factory for the production of insulin in Russia • On April 10, 2015 company Novo Nordisk opened Novo Nordisk opens a new manufacturing facility in Russia • Manufacturing comprises preparing an insulin solution, filling and packing Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  76. 76. Sanofi can build a plant in Leningrad Oblast • Sanofi is considering construction of the plant in the territory of Leningrad Oblast • The Memorandum of Understanding signed between Sanofi Russia and the Government of Leningrad Oblast at the XIII International Investment Forum “Sochi-2014”. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  77. 77. Cadila In 2013, Cadila Pharmaceuticals Ltd. decided to build a pharmaceutical plant in Narimanov District of Astrakhan Oblast Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  78. 78. R-Pharm and Eli Lilly R-Pharm and Eli Lilly plan to launch manufacture of the entire insulin line from 2015 at a plant in Kostroma (Central Russia) owned by the Russian partner. Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  79. 79. RPhG M&A Advisory Services RPhG advise both domestic and international companies to assist their goals in Russia, include: – Evaluation of Russian prospect client by identifying factors leading to a sale decision – Organization and conducting M&A negotiations in close cooperation with the client – Coordination of the whole negotiating and selling process between parties – Confidential approach of potential acquirers and vendors – Company analysis incl. due deal Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
  80. 80. Contact Vladimir Krasnikov, Director General Russian Pharmalicensing Group LLC 27, Presnensky Val, office 814 Moscow 123557, Russia tel.: +7 495 640 5275 fax: +7 495 640 5276 email: Vladimir.Krasnikov@pharmalicensing.ru site: www.regulatoryaffairs.ru Creating a safer environment by bridging business culture gaps Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015

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