Dr. Raj Shea

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by Dr. Raj Shea Director, Business Development
for ECOPHARMUSA
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Program Overview


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

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

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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)
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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.

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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

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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
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State of the Art Facility
World Class Clean Rooms and Equipment
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Sales of Pharmaceutical Products2001 - 2006 in
millions (Euros)

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Ecopharm Gross Sales 2005 in millions (Euros)

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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

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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

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Segment 2 - Clinical Trials Overview

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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

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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

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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
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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)
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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

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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

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Clinical Trials

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Clinical Trials

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Randomized Studies In Phase 3

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Post Market Clinical Trials Phase 4

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CRO Partners

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

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Segment 3 Dermatology in Bulgaria/Eastern
Europe

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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

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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

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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

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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

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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

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Companies Sponsoring Dermatology Clinical Trials
in Bulgaria

• Serono
• Johnson Johnson
• Galderma
• Astellas
• Grunenthal
• Basilea Pharmaceutical Ltd
• Novartis
• Cosmetic companies
• GlaxoSmithKline

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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

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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.

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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

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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

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Thank you