Innovation at Teva,
an Israeli-Hungarian company
in Hungary
Dr. Ildikó Mihók
R&D Director
TEVA Pharmaceutical Works Privat...
TEVA PHARMACEUTICAL INDUSTRIES Ltd.


TEVA is a capital-intensive multinational company with a stable financial backgroun...
HISTORY OF BIOGAL/TEVA PHARMACEUTICALS

Biogal Pharmaceutical Works was formed relatively late, in 1960, when two
smaller ...
HISTORY OF BIOGAL/TEVA PHARMACEUTICALS
1995:

The privatization of BIOGAL by the Israeli company is a true success story. ...
GSC
GÖDÖLLŐ STERIL CENTER

MEGAPACK
DEBRECEN

Cytotoxic, non-cytotoxic production

20 packaging lines, full automatic logi...
TPW IN HUNGARY
Debrecen, HUNGARY
Area: 220,000 m² Number of employees:
1675
Sales revenue in 2012: 165 billion HUF
Domesti...
WHAT DID PRIVATIZATION BRING IN OUR
COMPANY’S LIFE?

- New and more efficient organization of the work, transformation of ...
ORGANIZATION CHART

GBP QA
GBP QA

R & D DIVISION
R & D DIVISION
Archives
Archives
Admin Assist
Admin Assist

Quality
Qual...
INNOVATIVE R & D IN TPW
Biological Units in Debrecen and Godollo sites
Testing biologics (innovative and biosimilars) in b...
INNOVATIVE R & D IN TPW
 Bioanalytical Unit – established for the purpose to determine the concentration of
drug candidat...
SCIENTIFIC RELATIONSHIPS
- During the years the traditional preclinical and clinical R&D relationship, with the
Hungarian ...
RELATIONSHIP BETWEEN DEBRECEN UNIVERSITY
AND TPW
 Our pharmaceutical company and the Debrecen University have been workin...
Benefits of this collaboration



Numerous former university students find employment at our company, which is
due to the...
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2013 09 25_ildiko_innovation at teva

  1. 1. Innovation at Teva, an Israeli-Hungarian company in Hungary Dr. Ildikó Mihók R&D Director TEVA Pharmaceutical Works Private Ltd., Co., Debrecen 2013 1
  2. 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. 2
  3. 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. 3
  4. 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. 4
  5. 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 5
  6. 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 6
  7. 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. 7
  8. 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 8 Pharmacovigilance Pharmacovigilance Department Department
  9. 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 9
  10. 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 10
  11. 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. 11
  12. 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. 12
  13. 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. 13

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