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Dr. Raj Shea

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World Class Manufacturing & Distribution Facility of ... ORGANON USA/Netherlands. 9/15/09. 12. Future Goals * Establishment of new strategic partnerships ... – PowerPoint PPT presentation

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Title: Dr. Raj Shea


1
by Dr. Raj Shea Director, Business Development
for ECOPHARMUSA
2

Program Overview


Segment 1 ----- The Company Profile Segment 2
----- Clinical Trials Overview Segment 3 -----
Dermatology Overview in
Bulgaria/Eastern Europe




3

Segment 1 ----- The Company Profile World
Class Manufacturing Distribution Facility of
ECOPHARM in Bulgaria






4

Eastern Europe

Bulgarian Profile Population (2006 est.)
7,385,367. Growth rate (2006 est.) -0.86. GDP
(2005 est.) 25.79 billion. Real GDP growth
5.5 (2005 est.) 4.3 (2003). Per Capita GDP
(PPP, 2005 est.) 9,600. Inflation rate 5
(2005) 6 (2004) 5.6 (2003) Exchange rate BGL
per 1 USD -1.5741 (2005)



Gateway to Eastern Europe Distribution
Manufacturing ____________________________ Russia,
Kazakhstan, Ukraine and Newly Independent
States (NIS)
5
The Company
  • Ecopharm Bulgaria is a Bulgarian pharmaceutical
    company established in 2000 as a spinoff of the
    German company ASTA Medica on the Bulgarian
    pharmaceutical market. Ecopharm Bulgaria
    exclusively represents a number of prominent
    international pharmaceutical companies in
    Bulgaria. As a fast growing company, Ecopharm has
    launched large range of own branded and generic
    products during the last few years. Ecopharm also
    is the major Bulgarian company involved in
    clinical trials as a CRO for multiple American
    and European companies. It therefore offers both
    advantages for clinical trials and marketing of
    these products once approval is obtained in
    Easter Europe.
  • Ecopharm USA is the American subsidiary of
    Ecopharm BG. It was established in 2006 for the
    purposes of partnering with American
    pharmaceutical companies to have clinical trials
    performed in Bulgaria and other Eastern European
    countries. These are done to the highest
    multinational standards with substantial cost
    savings. Also Ecopharm USA is constantly
    searching for American pharmaceutical products to
    be distributed in the lucrative Bulgarian and
    Eastern European market where Ecopharm BG has an
    excellent established network for distribution
    channels, marketing and manufacturing expertise.

6
ECOPHARMUSA Management Team
  • Chairman Founder of ECOPHARMUSA/BG Dr. Peter
    Velev, MD
  • Ecopharm
  • President/CEO of ECOPHARMUSA Nina Shea, BSc
  • Worldwide Business Development Dr. Raj Shea,
    Phd.
  • ECOPHARMUSA Commercial Specialist and
    FDA Regulatory Affairs

7
State of the Art Manufacturing Facility -- for
both Solid Forms and Topicals Bulgaria

Located approximately 30 minutes north of Sofia
making it central for distribution in Bulgaria
and Eastern Europe
8
State of the Art Facility
World Class Clean Rooms and Equipment
9

Sales of Pharmaceutical Products2001 - 2006 in
millions (Euros)

10

Ecopharm Gross Sales 2005 in millions (Euros)

11
Exclusive Representation in the Bulgarian Market
  • AWD PHARMA GmbH Co.KG Germany
  • BAXTER USA
  • MEDA PHARMA GmbH Co.KG Germany
  • LABORATOIRES BESINS INTERNATIONAL France
  • PLIVA BARR PHARMACEUTICALS USA
  • OLAINE CHEMICAL - PHARMACEUTICAL PLANT Latvia
  • CADILA PHARMACEUTICALS LIMITED India
  • CLARIS LIFESCIENCES LIMITED India
  • RAMBAXY India
  • DABUR India
  • GENERICON Austria
  • ORGANON USA/Netherlands


12

Future Goals
Establishment of new strategic partnerships
Further CRO business development with new
partners Strengthen Ecopharm's operations on
the Bulgarian market through product
portfolio extension with own products and
licensing Expand and increase market-share
with our partner Genericon to Kazakhstan,
Russian, Romanian and other markets

13

Segment 2 - Clinical Trials Overview






14
Why perform Clinical Trials in Bulgaria?
  • Cost savings
  • Favorable price/quality ratio
  • Clinical trials have increased 10 times over the
    last 10 years
  • - 10 total studies in Bulgaria in 1995 to 148
    total studies in 2004
  • 41 increase in phase 3 studies over 5 years
  • Field of interest includes oncology, dermatology,
    psychiatry, cardio-pulmonary, gastrointestinal,
    neurology etc. Currently we are performing
    trials in oncology and urology
  • 5 of all the worldwide clinical trials are being
    performed in Bulgaria
  • This is one of the highest of any country
    worldwide, when you take into account Bulgarias
    size

15
Why perform Clinical Trials with ECOPHARM?
  • Managed by strong Project Managers and Management
    team
  • Efficient communications plan that meets the
    sponsors needs
  • Contingency Strategies to reduce or eliminate
    negative impact
  • Defined project plan identifying tasks, key
    milestones and progress
  • Centralized patient database
  • Licensed and well equipped laboratories in
    accordance with GLP practices
  • Studies are performed according to the GCP
    guidelines
  • Highly educated medical work force with English
    Language capability
  • Fast enrollment of patients
  • Accountability and accurate results
  • Cost Savings in terms of labor
  • Leading medical experts on Advisory Committee
  • Ability to step-in and rescue delayed or poorly
    enrolled clinical trials
  • Access to European and American trained Clinical
    Investigators and support staff
  • After the drug is approved Ecopharm BG can launch
    the product in Bulgaria and Eastern Europe
  • Medical publishing house to educate and launch
    new products, develop marketing and sales force
    infrastructure
  • Drug manufacturing facility with the highest
    standards
  • Distribution channel with minimum Foreign Direct
    Investment

16
Structure Ecopharm Bulgaria
HRM
Chairman CEO
Controlling
Head Office Manager
Medical Director
Finance Director
Legal Administration Director
C R O Structure
Board of Directors
I T M
S F M
5 B U M
R A M
H A
B D M
S C M
2 ITA
2 SA
3 RSF
3 HM
Cardiology 4 PM
CNS 2 PM
Oncology PM
WHM
3 RAA
4 A
C
B W C M
Cardiology 39 MR CNS 8 MR Oncology 5
MR
VWHM 3 WHA
4 TA
2 LA
PS 2
17
CRO Structure Ecopharm Bulgaria
Medical Consulting Advisory Board
Division Head
Business Development Manager
Administrative Regulatory Manager
Monitors
Supervisor Business Development Manager
(Germany) Clinical Research Consultant (Germany)
18
Medical Advisory Board
  • Prof. Dr. Assen Gudev, Ph.D. Head of
    cardiology dept, University Hospital Queen
    Joanna, Sofia
  • Prof. Dr. Krassimir Neykov, Ph.D. Head of
    urology dept., Specialized Hospital in Oncology,
    Sofia
  • Prof. Dr. Michail Nikolovski, Ph.D. Head of
    kidney transplantation dept., University Hospital
    Alexandrovska, Sofia
  • Prof. Dr. Ivan Milanov, Ph.D. Executive
    Director of the Specialized Hospital in Neurology
    and Psychiatry, Sofia and deputy Director of the
    Medical University, Sofia
  • Prof. Dr. Valentina Tsekova, Ph.D. Head of
    oncology department, University Hospital Queen
    Joanna, Sofia
  • Prof. Dr. Stoyan Tonev, Ph.D. Executive
    Director of the Military Hospital, Sofia,
    dermatologist
  • Prof. Dr. Eliyan Rachev, Ph.D. Head of
    gynecology dept., Chairman of the Bulgarian
    Gynecology Society and Chairman of the Bulgarian
    Association in menopause

19
CRO Summary
  • Since 2001 - 2006 --24 Clinical Trials were
    conducted by Ecopharm, as follows
  • Phase I 5 studies
  • Phase II 7 studies
  • Phase III 7 studies
  • Phase IV 4 studies
  • Retrospective study 1 study
  • More than 900 patients treated
  • More than 4 000 patients with oncology diseases
    were included in a post marketing comparative
    studies
  • All Clinical Trials were conducted by Ecopharm
    according to GCP
  • 3 new studies will start till the end of 2006

20

Clinical Trials

21
Clinical Trials

22
Randomized Studies In Phase 3

23
Post Market Clinical Trials Phase 4

24

CRO Partners
  • Aeterna Zentaris Canada
  • Eastcom Czech Republic
  • Spectrum Pharmaceuticals USA
  • Ardana Bioscience UK
  • Genericon Austria
  • Intas/Lambda Therapeuticals India
  • PRINTO Italy

25

Segment 3 Dermatology in Bulgaria/Eastern
Europe






26

Dermatology (Healthcare Structure)

11 Regional Dispensaries 5 University
Hospitals with Dermatology Clinics 25
Multi-profile Hospitals for Active Treatment with
Dermatology wards Military Medical Academy
Dermatology Clinic at SOFIA Ministry of
Internal Affairs Hospital with Dermatology ward


27

Dermatology Opinion Leaders
  • Prof. Dr. Nikolai Tsankov, Chairman of the
    Bulgarian Dermatology Society and Head of
    Dermatology Clinic at Alexsandrovska
    University Hospital
  • Prof. Dr. Miroslava Kadurina Member of
    European Academy of Dermatology and of the World
    Association of Dermatopathology, and Head of the
    Dermatology Clinic at the Military Medical
    Academy
  • Prof. Dr. Stoyan Tonev Head of Military
    Medical Academy



28

Clinics with Experience in Clinical Trials

  • University Hospital Alexandrovska Sofia
  • Military Medical Academy Sofia
  • University Hospital Dr. G. Stranski- Pleven
  • University Hospital Sv. Georgy Plovdiv
  • University Hospital Stara Zagora
  • University Hospital Sv. Marina - Varna



29

Reasons to run Dermatological Clinical Trials
with ECOPHARM
  • Ability to perform rapid study initiation
  • Access to large pools of patients at
    centralized medical institutions
  • Significant numbers of Drug naïve patients
    across numerous therapeutic areas
  • Access to European and American trained
    Clinical Investigators and support staff
  • Highly educated medical work force with
    English Language capability
  • Managed by strong Project Managers and
    Management team
  • Efficient communications plan that meets the
    sponsors needs
  • Contingency Strategies to reduce or eliminate
    negative impact
  • Defined project plan identifying tasks, key
    milestones and progress
  • Centralized patient database
  • Ability to step-in and rescue delayed or poorly
    enrolled clinical trials
  • After the drug is approved Ecopharm BG can
    launch the product in Bulgaria and Eastern Europe





30

Most Common Dermatologic Diseases in Bulgaria
  • Psoriasis approximately 5 of the population
  • Atopic Dermatitis (Eczema) approximately 6
    of the population
  • Mycoses approximately 60 of the population
  • Acne - approximately 15-20 of the
    population
  • Comment The rate of general dermatology
    diseases does not differ from the average rate in
    Europe




31

Companies Sponsoring Dermatology Clinical Trials
in Bulgaria
  • Serono
  • Johnson Johnson
  • Galderma
  • Astellas
  • Grunenthal
  • Basilea Pharmaceutical Ltd
  • Novartis
  • Cosmetic companies
  • GlaxoSmithKline




32

Number of Clinical Trials in Dermatology

Less than 3 out of the total number of clinical
trials based on the annual report (2005) of the
Bulgarian Drug Agency



33

Number of Dermatologists in Bulgaria


Over 400 (600 if you include retired
doctors) Half of them working in the capital
city of Sofia Almost all of them have private
practice in addition to their primary
occupation Professional Organization
Bulgarian Dermatology Society Most
professionals attend European and American
Dermatology conferences. Also obtain continuing
medical education to stay current.



34

General Changes to Follow After the Admission of
Bulgaria to the EU in January 1, 2007



A new Law on drugs (new regulation on Clinical
Trials), January 1, 2007 Consequences
Easier access to patients (also in private
clinics/ excellent equipment and qualified
doctors) Shorter time for getting
Authorization to conduct Clinical Trials



35

In Summary
  • ECOPHARM CRO Advantages
  • Ecopharm is one of the most reliable CRO in
    Bulgaria
  • Can perform clinical trials in multi-disease
    states and multiple organ systems
  • Strong Management Team with Project Management
    Experience
  • Strong Ethical Values
  • Fast patient enrollment and centralized
    database
  • Skilled workforce with English Language
    capability
  • Efficient communication systems that meets the
    sponsors needs
  • ECOPHARM Pharmaceutical Advantages
  • Explosive Growth with minimum Foreign Direct
    Investment
  • Manufacturing and Distribution capacity
  • Use of existing channel marketing into Eastern
    Europe
  • Launch of new products


36
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