1. Innovation at Teva,
an Israeli-Hungarian company
in Hungary
Dr. Ildikó Mihók
R&D Director
TEVA Pharmaceutical Works Private Ltd., Co., Debrecen
2013
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2. TEVA PHARMACEUTICAL INDUSTRIES Ltd.

TEVA is a capital-intensive multinational company with a stable financial background
and more than 111 years professional experience.

It is the world’s largest generic pharmaceutical manufacturing company; its global
product portfolio (which includes more than 1000 molecules) is comprehensive,
strong and robust.

It is directly present in more than 60 countries worldwide.

It employs nearly 46,000 people.

It has more than 73 sites worldwide where medicinal products and active
pharmaceutical ingredients are manufactured.

More than 25 R&D centers.

Teva’s branded business focus on CNS, oncology, pain, respiratory and women’s
health therapeutic areas as well as biologics.

TEVA riched 20.3 billion USD in net revenues in 2012.
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3. HISTORY OF BIOGAL/TEVA PHARMACEUTICALS
Biogal Pharmaceutical Works was formed relatively late, in 1960, when two
smaller (earlier-founded) pharmaceutical companies, the Pharmaceutical
Factory founded in 1912 by the Rex brothers, and Hajdúsági Pharmaceutical Works
founded in 1952 were merged. The two plants were merged to form Biogal
Pharmaceutical
Works combining the new companies’ interests in biosynthetic
fermentation and galenical pharmaceutics.
The acquisition of Biogal Pharmaceutical Works Debrecen – by Teva – represented
the start of a new innovation in the Hungarian pharmaceutical industry under the
direction of a foreign company headquartered in a country which stands on third
place in the world in innovation. This country is Israel.
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4. HISTORY OF BIOGAL/TEVA PHARMACEUTICALS
1995:
The privatization of BIOGAL by the Israeli company is a true success story. Its
integration into TEVA’s international network has resulted in the rationalization of
internal organization and acceleration of its technical, economical and
its
commercial
development.
1998:
BIOGAL-Teva Pharma was founded for marketing and promotion activities.
2000:
Acquisition of Human (in Godollo), owned before by Novopharm (Canada).
2004:
1st December: BIOGAL changed its name to Teva Pharmaceutical Works
Private Limited Company.
2005:
1st January: The two companies (Biogal and Human) merged under the name of
TEVA Pharmaceuticals Ltd.
New API plant was established in Sajobabony.
2006:
New logistic center was built in Godollo.
2008-2010: MegaPack Plant in Debrecen was built to double the pharma production and
packaging capacity.
2010-2014: New sterile plant in Godollo was built to double the sterile capacity.
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5. GSC
GÖDÖLLŐ STERIL CENTER
MEGAPACK
DEBRECEN
Cytotoxic, non-cytotoxic production
20 packaging lines, full automatic logistic system
(eye-drops in the future)
last year 5,7 billion units
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6. TPW IN HUNGARY
Debrecen, HUNGARY
Area: 220,000 m² Number of employees:
1675
Sales revenue in 2012: 165 billion HUF
Domestic sales revenue: 10.8 billion HUF
Export sales revenue: 155 billion HUF
Main activities: solid dosage forms &
manufacturing of active pharmaceutical
ingredients; R&D activities
Sajóbábony, HUNGARY
Area: 35,000 m² Number of employees:
60
Main activities: manufacturing of active
pharmaceutical ingredients
Gödöllő, HUNGARY
Area: 200,000 m² Number of employees:
825
Sales revenue in 2012: 23 billion HUF
Domestic sales revenue: 4.2 billion HUF
Export sales revenue: 18.8 billion HUF
Main activities: sterile manufacturing; R&D
activities, wholesale distribution
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7. WHAT DID PRIVATIZATION BRING IN OUR
COMPANY’S LIFE?
- New and more efficient organization of the work, transformation of company structure,
outsourcing of numerous general activities, such as technical services, maintenance,
repairs, etc.
- A change in professional philosophy:
-- Research must be focused on areas with a market demand, for which areas scientific
background can be ensured in-house or possibly in cooperation with external
organizations.
-- Novel uses for existing investigational capacities.
-- In-house extension of ADME, toxicological and bioanalytical testing methods into new
fields of indication.
-- Winding-up of parallelisms and termination of previously pursued fields of indication.
- Activities in new fields of indication, e.g. CNS, autoimmune diseases.
- Extension of fields of indication: respiratory, oncology, pain, biologics.
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8. ORGANIZATION CHART
GBP QA
GBP QA
R & D DIVISION
R & D DIVISION
Archives
Archives
Admin Assist
Admin Assist
Quality
Quality
Assurance
Assurance
Group
Group
Planning
Planning
&
&
Control
Control
Biological Testing Dept.
Biological Testing Dept.
QC Group
Gödöllő
Central Regulatory Affairs and
Central Regulatory Affairs and
PhV General Department
PhV General Department
Regulatory
Regulatory
Affairs Department
Affairs Department
Debrecen
Debrecen
Regulatory
Regulatory
Affairs Department
Affairs Department
Gödöllö
Gödöllö
Bioanalytical Laboratory
Bioanalytical Laboratory
QC and Drug
Metabolism Group
Debrecen
Innovative R&D
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Pharmacovigilance
Pharmacovigilance
Department
Department

9. INNOVATIVE R & D IN TPW
Biological Units in Debrecen and Godollo sites
Testing biologics (innovative and biosimilars) in bioassays (in vivo, in vitro, ex vivo)


GMP
Development, validation, transfer, run of bioassays for quality control
GMP qualified site for product release with bioassays

Official release/test site of Copaxone, Neugranin, biosimilars and for other
biologics


GLP
GCP
Ligand binding assays, cell based potency assays, in vivo assays
Bioanalysis of preclinical and clinical samples with ligand binding assays

Ligand binding assays development, validation

Cytochrome P450 inhibition tests

ADME activities - PK studies and bioanalysis of samples
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10. INNOVATIVE R & D IN TPW
 Bioanalytical Unit – established for the purpose to determine the concentration of
drug candidates and their metabolites in biological samples (plasma, urine)
originated in preclinical (animal) and clinical trials (human)
Requirements: high selectivity and sensitivity
Analysis up to pg/ml (10-12 g/mL) level in biological matrix by LC/MS/MS
 Accreditations
Biological Unit release site for EU and US
FDA inspection
Regular inspection by National Institute of Pharmacy
 Regulatory Affairs activity in Debrecen and Godollo sites
Maintenance of EU files and preparation of new submission files to EMIA, ASIA,
LATAM, CA and US
Handling 600 generic molecules, from which 70 % is coming from in-house
development
 Pharmacovigilance activity
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11. SCIENTIFIC RELATIONSHIPS
- During the years the traditional preclinical and clinical R&D relationship, with the
Hungarian Medical Universities, in the field of clinical pharmacology and clinical
therapeutic research (CNS, autoimmune diseases) were maintained and extended to
collaborations with other institutes.
- In the field of preclinical R&D, our almost 15-year relationship with the Institute of
Experimental Medical Research (Hungarian Academy of Sciences) was an important
background.
- A special form of scientific relationships is the regular professional consultations with
the National Institute of Pharmacy, which mainly serve the purposes of clinical research
and registration.
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12. RELATIONSHIP BETWEEN DEBRECEN UNIVERSITY
AND TPW
 Our pharmaceutical company and the Debrecen University have been working in
collaboration for several decades. We are working together successfully in several
fields, one of the most important is the issue of recruitment of new professionals.
 In December 2007 a collaboration agreement on the establishment of a
Pharmaceutical Industrial External Faculty was signed.
 Within the framework of this collaboration, the relationship between the University
and TEVA has become closer and closer over the years.
 The number of students within the Faculty who intend to write their graduation
theses at TEVA Pharmaceuticals Ltd. has been increasing exponentially over the
years, and we help students’ education in different fields.
 In July 2011 the establishment of another external industrial faculty was
announced for the education of general pharmacists, with the involvement of
professionals of the Pharma Division of our company.
 The directors of both external industrial faculties participate in compiling the
education program, organizing and holding lectures, and examining students.
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13. Benefits of this collaboration

Numerous former university students find employment at our company, which is
due to the fact that students can gain an insight into the work performed at the
company as early as during their university years.
 It is noteworthy that both theoretical presentations and practices are held by TEVA
employees, so students can obtain „first-hand” knowledge on numerous special
fields in pharmaceutical industry, such as tasks of biotechnological R&D,
manufacturing of active pharmaceutical ingredients (primarily fermentation) and solid
dosage forms, analytical work and quality control.
 Students can also gain practical experience and an insight into „real” full-scale
manufacturing of active pharmaceutical ingredients.
 The knowledge obtained in this way is incorporated into the system of university
theoretical education and laboratory practices.
 Upon changes in company demands, we can employ specialists with more readily
convertible knowledge in the field of R&D, active pharmaceutical ingredients and
manufacturing.
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