2012 Rating Manufacturer Cost volume, mln. 2012 Share

1 NOVARTIS 42 373,4 5,5%2 SANOFI 40 257,3 5,2%3 PHARMSTANDART 27 630,2 3,6%4 F.HOFFMANN-LA ROCHE 23 674,5 3,1%5 TEVA PHARMACEUTICAL 22 880,8 3,0%

TOP-5 manufacturers by sales of the pharmaceutical market in Russia 2012

№ Constituent elements of price %

1. Manufacturer 35

2. Customs duty 10

3. Tax 10

4. Distributor surcharge 15

5. Pharmacy surcharge 30

Retail price structure of the imported pharmaceutical in Russia.

The volume of imports, million dollars.

Companies specializing in the direct import

Foreign manufacturers representatives

Domestic pharmaceutical manufacturers

Distribution companies

Rating Importers Share of the volume of imports in 2012, %

1 DISTRIBUTION COMPANIES 24,412 FOREIGN COMPANIES

REPRESENTATIVES66,08

3 COMPANIES SPECIALIZING IN THE DIRECT IMPORT

4,42

4 DOMESTIC PHARMACEUTICAL MANUFACTURERS

5,09

Total: 100 The volume of imports, $ mln. 14 399

The share of different groups of importers of pharmaceuticals in Russia in the volume of imports of pharmaceuticals in 2012

Rating Foreign manufacturers representatives Share of total imports in the group «Representatives…», 2012 г., %

1 SANOFI 10,6%2 NOVARTIS 9,7%3 BAYER 7,8%4 ABBOTT 6,7%5 JOHNSON & JOHNSON 5,8%6 TEVA 5,6%7 BOEHRINGER INGELHEIM 5,2%8 TAKEDA 4,6%9 GLAXOSMITHKLINE 4,5%

10 MSD PHARMACEUTICALS 4,1% Total: 64,6%

TOP-10 foreign manufacturers representatives by imports in 2012

Rating Distributor Share of total imports in the group «Distribution companies», 2012 г., %

1 Company «PROTEK» 17,1%2 R-PHARM 16,3%3 KATREN 11,3%4 SIA International 10,2%5 BIOTEC 9,0%6 ROSTA 8,6%7 EUROSERVICE 4,4%8 Oriola 4,4%9 Alliance Healthcare Russia 3,9%

10 PC PULS 2,7% Итого: 88,0%

TOP-10 distributors by pharmaceuticals import in Russia in 2012

2012 rating Pharmaceutical manufacturer Cost volume, mln rubles. 2012

Share

1 NOVARTIS 24 759 6,07%2 SANOFI 21 838 5,36%3 PHARMSTANDART 17 718 4,35%4 BERLIN-CHEMIE 13 992 3,43%5 TAKEDA 13 534 3,32%6 BAYER 13 252 3,25%7 TEVA 12 532 3,07%8 GEDEON RICHTER 11 409 2,80%9 PFIZER 11 081 2,72%

10 ABBOTT 10 867 2,67%11 SERVIER 10 613 2,60%12 KRKA 8 542 2,10%13 STADA 8 399 2,06%14 MERCK 7 930 1,95%15 BOEHRINGER INGELHEIM 7 539 1,85%16 ASTELLAS PHARMA 7 012 1,72%17 DR.REDDY’S LABORATORIES 6 431 1,58%18 ACTAVIS GROUP 5 780 1,42%19 GLAXOSMITHKLINE 5 758 1,41%20 JANSSEN PHARMACEUTICA 4 545 1,11%

TOP-20 pharmaceutical manufacturers by pharmacy sales at the Russian retail commercial market in 2012

2012 Rating Brand Cost volume, mln rubles. 2012

Share

1 ESSENTIALE 3 812 0,93%2 ARBIDOL 3 744 0,92%3 CONCOR 3 291 0,81%4 ACTOVEGIN 3 214 0,79%5 VIAGRA 3 037 0,75%6 LINEX 2 892 0,71%7 NUROFEN 2 844 0,70%8 ALFLUTOP 2 683 0,66%9 TERAFLU 2 443 0,60%

10 DETRALEX 2 336 0,57%11 NISE 2 218 0,54%12 NO-SHPA 2 095 0,51%13 LASOLVAN 2 091 0,51%14 REDUXIN 2 079 0,51%15 ANAFERON 2 077 0,51%16 MEXIDOL 2 054 0,50%17 MILGAMMA 2 053 0,50%18 KAGOCEL 2 049 0,50%19 MOVALIS 2 021 0,50%20 OSCILLOCOCCINUM 2 013 0,49%

Top 20 brands by sales volume in terms of value in the commercial market in Russia 2012

INN % Of sales VED, rub. Volume, mln rub. The leader among the brands within

the INN1 XYLOMETAZOLINE 4,17% 5 287 TIZIN2 PANCREATINE 3,57% 4 531 MEZYM FORTE3 BISOPROPOL 3,08% 3 906 CONCOR4 UMIFENOVIRUM 2,95% 3 744 ARBIDOL5 AZITHROMYCIN 2,40% 3 039 SUMAMED6 AMOXICILLIN/CLAVULANIC ACID 2,25% 2 848 AMOKSIKLAV7 ENALAPRIL 2,03% 2 576 ENALAPRIL8 ETHYLMETHYLHYDROXYPYRIDINE

SUCCINATE1,81% 2 298 MEXIDOL

9 FLUCONAZOLE 1,80% 2 278 FLUCOSTAT10 DROTAVERINE 1,78% 2 255 NO-SHPA

Sales rating of INN’s, included in the VEP

Sales ration of domestic and imported supplements, broken down by country

Cost volume

Actual volumeRussiaimport

Germany

USADenmarkMalaysia

NetherlandsCanada

China

Other countries

2012 Rating

Brand Company Cost volume, mln rubles. 2012

Share

1 TURBOSLIM EVALAR 1 212 5,5%2 SEALEX FORTE RIA PANDA 1 077 4,9%3 ALI KAPS RIA PANDA 649 2,9%4 FITOLAX EVALAR 637 2,9%5 ALFAVIT AKVION 541 2,4%

TOP-5 selling brands of supplements in Russia in 2012

Ingredient Bolvit (France) suppl.

Alfavit (Pharmstandart)suppl. Complivit (Pharmstandart)

Аerovit (Pharmstandart)

Selmevit (Valenta)

BIO-MAX (Valenta)

Vegetable collagen 1000 mg

Iron 112 mg 18 mg 5 mg 2,5 mg 5 mgCalcium 110 mg 100 mg 50,5 mg 10 mg 25 mg 50,5 mgZinc 104 mg 15 mg 2 mg 2 mg 2 mg

Vitamin С 60,6 mg 80 mg 50 mg 100 mg 35 mg 50 mg

Selenium 50 mg 25 mcg 0,025 mg Magnesium 18,3 mg 40 mg 16,4 mg 40 mg 35 mgVitamin В3 18 mg 80 mg

Vitamin Е 10 mg 10 mg 10 mg 20 mg 7,5 mg 10 mg

Copper 7,2 mg 2 mg 0,75 mg 0,4 mg 0,75 mgVitamin В5 6 mg 5 mg 5 mg 5 mg

Manganese 3 mg 2,5 mg 2,5 mg 1,25 mg 2,5 mg

Vitamin В6 2 mg 1 mg 5 mg 10 mg 2,5 mg 5 mgVitamin В2 1,4 mg 1,7 mg 1,27 mg 2 mg 1 mg 1,27 mg

Vitamin В1 1,4 mg 1,5 mg 1 mg 2 mg 0,581 mg 1 mg

Vitamin А 800 mcg 1 mg 1,135 mg 6600 МЕ 0,568 mg 1,135 mg Iodine 18 mcg 150 mcg Vitamin D3 5 mcg Folacin 2 mcg

Vitamin В12 1 mcg 3 mcg 12,5 mcg 25 mcg 0,003 mg 0,0125 mg

Market price per pack. 200 rub. 100 rub. 50 rub. 180 rub. 150 rub.

Comparison of the vitamin and mineral complexes.

Orientation of patients on the Russian medications

Minor ailmentsModerately

severe

0

10

20

30

40

50

60

import

Russian

any

importRussianany

№ Name of the document Number of the document

1 Federal law «Circulation of Pharmaceuticals» № 61-FZ - April 12, 2010

2 Resolution of the Government of the Russian

Federation

№ 688 (2008).

3 Ministry of Health and Social Development

Orders

№№ N 428н (2012), 734

(2006), 903 (2006), 904

(2006), 657 (2007)

4 Resolution of the Russian State Committee № 5 (1994)

5 Roszdravnadzor’s informational letter 01И-61/07 (2007).

№ Types of expertise Conductor Stages

1. Pharmaceuticals evaluation

ФГБУ «НЦЭСМП» (Scientific Center for Expertise of Medical Products) (on assignment from the Ministry of Health)

1st step:A) Evaluate the documents, necessary for acquiring the permission to conduct clinical trials and ethical review of pharmaceuticals, for which clinical trials were not conducted in the Russian Federation.B) Conduct quality evaluation and risk analysis of the ratio between the expected benefits and possible risks of using this product for pharmaceuticals that were approved for use in Russia for more than 20 years, and for which international multi-center trials were held. 2nd step:

A) Evaluation of the proposed methods of quality control of pharmaceuticals and submitted samples, using these methods (evaluation of quality)B) Risk analysis of the ratio between the expected benefits and possible risks of using this product, carried out after the clinical trials.

2. Ethical review Ethical Committee (on assignment from the Ministry of Health)

Ethical review of the possibility of a clinical trial for the pharmaceutical’s medical use.

№ Stages Terms1. All government registration procedures 210 business days, including

second evaluations (up to 40 business days), not including CT

2. - Evaluation of documents necessary for acquiring the permission to conduct clinical trials ;- Quality evaluation and evaluation of possible benefits for pharmaceuticals, that are being used in Russia for over 20 years, or with Russian multi-center trials. (MoH)

5 business days

3. Evaluation of documents for compliance with the received task. (ФГБУ «НЦЭСМП») 30 business days4. The documents are studied, the applicant is notified about the possibility of CT. (MoH) 5 business days (the GR process

is suspended)5. Evaluation of documents from the applicant about the CT’s (MoH) 5 business days6. Quality Evaluation and Risk analysis of the ratio between the expected benefits and possible risks.

Conducted after getting the task and CT reports. (ФГБУ «НЦЭСМП»)110 business days

7. Verification of documents after the clinical trials and the resumption of the GR process. (MoH) 5 business days8. After the resumption of the GR process, the applicant submits samples of the pharmaceutical for

the quality evaluation. (ФГБУ «НЦЭСМП») 15 business days

9. MoH is notified about the samples received. (ФГБУ «НЦЭСМП») 3 business days10. After receiving the committee’s conclusions about the quality of medicines and ethical review,

decision is issued about the registration. (MoH)5 business days

11. GR is issued, the registry is updated (MoH)

Expedited procedure of registration for genericsIncluding quality evaluation and ethical review

60 business days15 business days

№ Members of the government registration procedure

Body of work

1. APPLICANT Submits the application for the government registration of pharmaceutical according to FZ-61 “Circulation of Pharmaceuticals ”, pays the fees, conducts CT’s in authorized Russian clinics after obtaining permission, submits samples of pharmaceuticals for quality evaluation.

2. MINISTRY OF HEALTH, RUSSIA Accepts the application, proof of payment and the registration dossier from the applicant; drafts the task for conducting the pharmaceutical evaluation and ethical review; grants permission for conducting CT’s; suspends and resumes the GR process; gets notifications from the expert agency on the conclusion of registration procedure; gets the reports from committees on the quality evaluation and ethical review; decides on granting the registration of pharmaceutical and updating the government registry; monitors the work of the expert agency and ethical committee.

3. EXPERT AGENCY (ФГБУ «НЦЭСМП») Gets a task of reviewing of the documents for the CT’s, quality evaluation and evaluation of the expected benefits; examines the documents for compliance with the received instructions, conducts the examination of samples in accordance with the task, submits the committees decision to the Ministry of Health in the Health Ministry.

4. ETHICAL COMMITTEE Gets a task of conducting the ethical review, then submits the decision to the Ministry of Health.

№ Name of the document Number of the document

1 Federal Laws №№ 52 (1999), 29 (2000)

2 Resolution of the Government of the Russian

Federation

№ 688 (2008)

 

3 Ministry of Health and Social Development Order № 657 (2007)

4 Federal Service for Supervision of Consumer

Rights Protection and Human Welfare Order

№ 224 (2007)

5 Russian FCS Letter № 01-11/11534 (2008)