DrugDrug registrationregistration andand labelinglabeling issuesissues

Dmitry Kochev Pentcroft Pharma

10 September, 2009 Tbilisi, Georgia

RussiaRussia

MiferistoneMiferistone inin RussiaRussia FromFrom 19991999 asas MifegyneMifegyne andand PencroftonePencroftone FromFrom 20020033 asas MifepristoneMifepristone MisoprostolMisoprostol inin RussiaRussia UpUp toto 20062006 useuse CytotecCytotec andand ArtrotecArtrotec FromFrom 20062006 MisoprostolMisoprostol labelledlabelled forfor MedicalMedical AbortionAbortion asas MisoprostolMisoprostol andand MirolutMirolut !!!! !!!! of charge of charge Local Total Analgesia for patient for patient Free Free ¾ ¾ Anastesia Anastesia ¾ Methods of in Methods of abortion in Russia EVA & MVA D&C with Intra-amnialD&E hypertonic Intracervical prostaglandins D&E very rare ¾ ¾ solution or ethacridine lactate ¾ ¾ ¾ First trimester First trimester ¾ ¾ (600+400) and Miso Mife Second trimester Second trimester AbortionAbortion clinicsclinics inin RussiaRussia

Private Medical Clinics

Women consultation Itrimester Private + government Government Hospitals

II trimester Maternity House Only in Government RussiaRussia StructureStructureStructure ofofof abortionabortionabortion ininin RussiaRussiaRussia (2007)(2007)(2007)

D&C First Trimester Mife+Miso up to 42d aminorea 78,4 % 1,72 %

>4 % 22,5 % 2 trimester MVA and EVA Intraamnial solution up to 12 week

11 trimestertrimester –– 12190401219040 (93,5%)(93,5%) 22 trimestertrimester –– 6317063170 (4,85(4,85%) Total 1302480 (official date) Expert value - more than 2 mln higher MiferpistoneMiferpistone andand MisoprostolMisoprostol inin RussiaRussia (2009)(2009)

1 trimester – upup toto 4242 daysdays aminoreaaminorea cc 20022002гг 2 trimester – notnot labeledlabeled

The only one Maternity House in RUSSIA use Mife+Miso for second trimester abortion 200 for 2007-2008 yy Method 3 tabls. po (by 200mg each 4 hours) + then po (200 mkg each 4 hours) RussiaRussia Expert value rate of MA in Russia

%

12,00%

10,00%

8,00%

6,00%

4,00%

2,00%

0,00% 2002г. 2003 2004 2005 2006 2007 2008

% 0,17% 0,70% 1,89% 4,00% 6,00% 9,00% 11,00%

Official rate by MOH -1,56% 56%, Sweden 51%

RussiaRussia Grow of Mifepristone sales in Russia Total figure (together all distributors appr. 400000 packages by 3 tabl)

40

35

30

25

% 20

15

10

5

0 2002 2003 2004 2005 2006 2007 2008 2009 RussiaRussia

MifepristoneMifepristone inin RussiaRussia TheThe onlyonly oneone officialofficial protocolprotocol ––””FrenchFrench protocolprotocol”” 600mgMife+600mgMife+ oraloral 400mkgMiso.400mkgMiso.

SomeSome ofof ourour clientsclients workwork withwith modernmodern protocolprotocol 200mgMife+200mgMife+ sublingsubling 400mkgMiso.400mkgMiso. BUTBUT NOTNOT OFFICIALOFFICIAL NobodyNobody hashas anyany problemproblem

SomeSome ofof ourour clientsclients workwork byby ““ownown”” protocolprotocol 600600--200mgMife+200mgMife+ 400400--600mkgMiso600mkgMiso. RussiaRussia Issues Associated with a Broader Distribution of Medical Abortion Technology in Russia 1. Current inability to use modern protocols legally. There are incremental changes but no major ones. 2. The need to educate doctors and convince them of the merits of modern technology; their fear of using new technologies, stemming from legal issues. 3. Limitations of the operation of the public healthcare system, stemming from the prohibition of fee-based services. 4. High cost of medical services in commercial clinics. 5. Government’s indifference toward the need to improve the situation with respect to abortion and its exclusive focus on the demographic situation. Positive Aspects 1. Patients like this method, and they have knowledge of it. 2. It is available in all regions of Russia. 3. There is a constant supply of medications, and there is consumer choice (competition between distributors). GeorgiaGeorgia

PencroftonePencroftone fromfrom 20042004

StartStart ofof realreal salessales fromfrom 20082008 ThroughThrough FAMILYFAMILY DoctorsDoctors

TotalTotal packagespackages 20082008--0909 -- 800800 byby 33 tabltabl.. AArmeniarmenia && AzerbaijanAzerbaijan

MadeMade thethe clinicalclinical researchresearch inin 20082008 withwith PencrftonePencrftone ,, MifepristoneMifepristone andand MisoprostolMisoprostol inin cooperationcooperation withwith GynuityGynuity HealthHealth ProjectProject

WeWe trytry toto findfind thethe commercialcommercial organizationorganization forfor distributiondistribution drugdrug inin thethe regions.regions. UzbekistanUzbekistan PencroftonePencroftone hashas thethe registrationregistration certificate,certificate, butbut dodo notnot distributedistribute onon thethe territory.territory. MainMain reasonreason isis economicaleconomical situationsituation withwith foreignforeign currency.currency.

MadeMade thethe clinicalclinical researchresearch inin 20082008 withwith PencrftonePencrftone andand MisoprostolMisoprostol inin cooperationcooperation withwith GynuityGynuity HealthHealth ProjectProject

WeWe trytry toto findfind thethe commercialcommercial organizationorganization forfor distributiondistribution drugdrug inin thethe regions.regions. KazakhstanKazakhstan

MifepristoneMifepristone andand MisostolMisostol registratedregistrated inin thethe regionregion (by(by ChineseChinese factory)factory) CISCIS countriescountries Issues Associated with a Broader Distribution of Medical Abortion Technology in Russia 1. The search for a suitable distribution partner is underway; it is possible to utilize the latest protocols. No significant problems with registration. 2. There is a need for comprehensive education of doctors and arguments for the use of modern technology. The fear of some leaders to “let the genie out of the bottle” sometimes prevents the implementation of new technologies. 3. Limitations of the operation of the public healthcare system, stemming from the prohibition of fee-based services. 4. High cost of medical services in commercial clinics. 5. Government’s indifference toward the need to improve the situation with respect to abortion and its exclusive focus on the demographic situation. Positive Aspects 1. Patients like this method, and they have knowledge of it. 2. There is a constant supply of medications, and there is consumer choice (competition between distributors).