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Transcript of Vladimir krasnikov april 22 2015 c_ph_i tokyo
Increasing Market Opportunities in the Emerging Russia as its’ Powerhouse
Vladimir Krasnikov, Director GeneralRUSSIAN PHARMALICENSING GROUP
Creating a safer environment by bridging business culture gaps
Tokyo, April 22, 2015
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
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
About RPhG(1)Company Information• Business Name: Russian Pharmalicesensing Group LLC (RPhG)• HQ: Moscow• Markets: Russia, ex-USSR countries, West Africa• Established: 2007Company 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
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
Creating a safer environment by bridging business culture gaps
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
Russian foreign trade partners
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
Rating CountryVolume, 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
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
Japan-Russia: "Sanctions? Business is above all“
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
Size and dynamics of retail pharmaceutical market of leading countries in 2012, bln $
USA
Japan
China
Germany
France
Brazil
Russia
Canada
Italy
UK
0 50 100 150 200 250
+21%
+10%
+16%
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
Source: DSM Group, Russia
Big Pharma Boys
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
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
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
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
ASTELLAS PHARMA*
5883038.053 16629643.7927
25941478.0417
31405955.1993
33510925.5139
1885169.9177
NY-COMED/TAKEDA
64853603.9676
85563045.4353999
114901352.0587
101618784.9594
101419930.0658
5570525.1306
5%
25%
45%
65%
85%
USD
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
ASTELLAS PHARMA*
29116227.9924
30293356.8889
30764256.985
21282045.1083
15858411.0119
4532741.7332
NY-COMED/TAKEDA
32886673.9693
36218197.2918
7451751.3152
6815765.8243
4879908.8675
764411.5442
5%
25%
45%
65%
85%
USD
Japanese origin drugs (FDF) manufacturers market in Russia, USD
2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3 2 0 1 40
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
701,564953,630
2,738,2382,358,399
4,665,755
2,904,785
4,307,748
5,812,633
7,843,290
6,447,368
4,081,189
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
Source: IMS Healthcare, Russia
Japanese drugs manufacturers in the Russian market
Manufacturers ATC3 product categories1. A05B2. G023. L01A4. L01B5. L01C6. L01D7. L01W8. N03A9. S01X
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
1. Biken2. Daiichi Pharm3. Japan Biopro. Inds.4. Kyowa5. Melsmon Pharm6. Nippon Kayako7. Sandzu Pharma8. Sankyo9. Taiho Pharma
Japanese API manufacturers in the Russian market
1. Yuki Kase Kogyo Ko.Ltd2. Shin-Yo CO., LTD3. Biochem Corporation4. SMIC SMO Ko.Ltd5. Kaneka Corporation6. Ajinomoto Ko.Ink7. Ionezava Hamari
Chemicals ltd. Japan8. Dayita Corporation
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
Japanese 20 APIs have been registered in Russia
Japanese nutritional supplement (FDF) market in Russia, USD
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
Source: IMS Healthcare, Russia
2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3 2 0 1 40
500,000
1,000,000
1,500,000
2,000,000
2,500,000
3,000,000
103,849 119,771 179,504360,111
508,507
2,423,054
1,058,4741,048,112
266,478
2,251,8872,449,616
Source: IMS Healthcare, Russia
Japanese nutritional supplements manufacturers in the Russian market
1. Arkray2. B2UP Co Ltd3. Cross Co Ltd4. Daiwa Pharm5. Orihido Co6. Osato Res. Inst.7. Paladium Corp8. Pharmaspray9. Shimizu Chemical10. Yanako Co
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
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
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
RUSSIAN HEALTHCARE AT A GLANCE
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
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 expectancyTotal: 66.25 yearsFor men: 63.5 years (80 years in Japan)*For women: 69 years (87 years in Japan)*
Healthcare infrastructure 5,000 state hospitals + 12,000 polyclinicsLess 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, 2015Sources: Russian MoH; *WHO Statistics 2014
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.
Size and Dynamics of Retail Pharmaceutical Market of Leading Countries in 2012, bln $
USA
Japan
China
Germany
France
Brazil
Russia
Canada
Italy
UK
0 50 100 150 200 250
+21%
+10%
+16%
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
Source: DSM Group, Russia
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
Ratio of the sales volume of Rx and OTC in 2014
Value-wise (RUR) Volume-wise (units)
50%50%
Rx OTC
30%
71%
Rx OTC
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
Source: DSM Group, Russia
Segments in the Russian Pharma Market
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
Commercial (retail)
59%Parapharmaceu-ticals16%
State pro-curerement
7%
Hospital18%
Source: DSM Group, Russia
The Russian Pharma Market by Segments in 2013-2014
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
2013y 2014y GrowthTOTAL, 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%
SegmentVolume, billion rubles
GrowthVolume, million units
Growth
Source: DSM Group, Russia
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%
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 22,62 Protek 133,2 2,96 15,7 8,43 ROSTA 93,8 2,08 11,1 14,34 SIA 83,7 1,86 9,9 -6,95 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 38,88 Oriola 40,5 0,9 4,8 8,29 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
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
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% 7092 Rigla 8.1 3.2% 29% 1 2023 Implosia 6.2 2.4% 18% 1 3504 А5 5.6 2.2% 23% 1 0055 Doctor Stoletov (incl. Ozerki) 5.4 2.1% 16% 3426 Raduga (incl. Pervaya Pomoshch) 3.9 1.5% -3% 8667 Pharmaimpex 3.4 1.3% 7% 5348 Pharmland 3.3 1.3% 66% 4859 Planeta Zdorovo 3.1 1.2% 37% 635
10 Samson-Pharma 2.4 1.0% 53% 4111 Vita 2.4 1.0% 11% 45712 Klassika 2.3 0.9% 2% 17813 Pharmacor 1.9 0.8% 16% 38014 Ladushka 1.8 0.7% 21% 22515 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
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
The categories of medicinal products are subject to the state registration
1. Original medicinal products2. Generic medicinal products3. New combinations of the previously
registered medicinal products4. New pharmaceutical forms and dosages of
the previously registered medicinal products
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
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
clinical2. Procedures for examination of the quality, effectiveness
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
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 scope4. Pharmaceutical expertise 5. Clinical trials (individually) 6. Registration certificate issuing
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
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
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
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
Clinical trials in FL No.61
BEFORE Law enactmentRegistration scheme in general conformed to international approach
AFTER Law enactmentUnique 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
45
State registration (listing in the Register) of APIs in Russia
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
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
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
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
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
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
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
Medical devices registration in Russia
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
Medical devices market in Russia
• Medical devices market values 4,2 bln USD in Russia in 2013
• Top 4 medical devices county origin ranks as1. China2. USA3. EU4. Russia
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
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
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.
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
www.RegulatoryAffairs.RU
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
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
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
Business development strategy
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
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 facilities3. Creation of cooperative management enterprise
with Russian (foreign) manufacturer including contract manufacturing (i.e. localization)
4. Russian market launch of new medicinal products5. No significant changes
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
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
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
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
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
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
Sotex Partners
Vladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015
BD strategy for beginners of Russian pharmaceutical market members
1. Independent entry into the market2. 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
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
Nycomed invested in pharma plant in Russia2006. Nycomed is ranked 9th among TOP-10 pharma companies in Russia2009. 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
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
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
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
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
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
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
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
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
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
Contact
Vladimir Krasnikov, Director GeneralRussian Pharmalicensing Group LLC27, Presnensky Val, office 814Moscow 123557, Russiatel.: +7 495 640 5275fax: +7 495 640 5276email: [email protected]: www.regulatoryaffairs.ru
Creating a safer environment by bridging business culture gapsVladimir Krasnikov | CPhI -2015 Tokyo, April 22, 2015