Gedeon Richter is a European specialty pharmaceutical company founded in 1901 based in Hungary. It has a portfolio of over 200 products and engages in original research, manufacturing, and sales globally with over 11,000 employees. The company focuses on areas like female healthcare, biosimilars, and central nervous system disorders through its R&D activities. It has ongoing clinical trials of over 12 new drug candidates and biosimilars in collaboration with other companies. Hungary is an optimal location for clinical studies due to its experienced professionals and harmonized regulations. Recent successes include FDA approval of its atypical antipsychotic drug cariprazine co-developed with Allergan.

1. R&D AND CLINICAL TRIALS
AT GEDEON RICHTER PLC.
Zsuzsa Beke
Head of Public Relations and Public Affairs

2.  European, innovation-oriented,
multinational specialty pharma company
 Founded: 1901
 Vertically integrated activity:
 original research
 process development
finished form / API manufacturing
 branded marketing and sales
 wholesale and retail
 Portfolio of 200 products
 Regional leader in R&D
 Global headcount: 11,431 people
GEDEON RICHTER PLC.

3. RICHTER GROUP
Sales (2015): EUR 1.18 bn
91% for export

4. RICHTER STRATEGY – SPECIALTY PHARMA
 Original research
 Female healthcare
 Biologicals

5. ORIGINAL RESEARCH
• R&D in focus since the establishment of Richter
• Unique research capacities in CEE
• Infrastructure: approx. 1,000 staff employed in R&D
• R&D budget: 10-12% of sales, EUR 112 mn in 2015
• Targeted area: CNS (13% of pharmaceutical sales)
• NCE pipeline: 12 ongoing projects
• Research and development agreements
– Allergan/Forest, Mitsubishi-Tanabe, Orion

6. FEMALE HEALTHCARE: COMPREHENSIVE PORTFOLIO
Contraception
• oral (I, II, III and IV generation)
• emergency contraceptive
• transdermal (patch)
• mechanical (IUD)
Uterine fibroid
Infertility
Post Surgical Abdominal Adhesions
High Risk Pregnancy
Benign Breast Disease
Women’s
Reproductive Medicine
Menopause
Symptoms (HRT)
Osteoporosis
Gynaecological
infections
• antifungals
Adolescent & young adult Mid-thirties to mid-forties Mid-forties and above
Two original products:
 Esmya for the treatment of uterine fibroids
 Bemfola for the treatment of infertility

7. BIOSIMILARS IN RICHTER
 Mammalian cell development – Hungary
 Bacterial development – Germany
 Targeted therapeutic areas
 oncology
 immunology
 Pegfilgrastim: first clinical trial in Q1 2014
 for treatment of neutropenia
 completed in Q2 2015 → filing in Q4 2015
 Teriparatide: first clinical trial in Q3 2014 (co-developed with Richter-Helm BioLogics)
 for treatment of postmenopausal osteoporosis
 completed in Q2 2015 → filing in Q4 2015
 Rituximab: first clinical trial in Q1 2015
 for treatment of certain forms of cancer and auto-immune diseases

8. HUNGARY IS OPTIMAL TO HOST A CLINICAL STUDY
 Hungarian legal regulations harmonised with international law
 ICH Good Clinical Practice standards of clinical study conduct
 Ethical approvals granted within reasonably short timelines
 High number of motivated and accessible patients, favourable recruitment
rates
 Experienced, highly qualified, scientifically engaged and well-prepared
medical & professional teams
 Well-functioning study networks (CRAs, project managers, medical experts
etc.)
 Reliable and high-quality results
 Biotechnology studies welcome as high-volumed oncologic and
rheumatologic centers are available
 Hungary’s location in the heart of Central and Eastern Europe provides
geopolitical and logistical advantages

9. MORE THAN 400 INVESTIGATIONAL CLINICAL TRIALS
ARE ONGOING IN HUNGARY IN 2016

10. Phase IV
Phase III
Phase II
Phase I
Report (2014) from the Association of Innovative Pharmaceutical Manufacturers (Hungarian modified, www.pharmaonline.hu)
MAJORITY OF STUDIES ARE IN PHASE II AND III

11. 2012
Report (2014) from the Association of Innovative Pharmaceutical Manufacturers (Hungarian modified, www.pharmaonline.hu)
ONCOLOGIC AND CNS STUDIES ARE LEADING

12. BIOSIMILAR RITUXIMAB DEVELOPMENT BY RICHTER
 Mechanism of action: targeted therapy against B cells
 Reference product: MabThera®, Roche
 Main indications: Non-Hodgkin lympoma, Chronic
lymphocytic leukemia, Rheumatoid arthritis
 Comparative PK/PD efficacy and safety study
in 12 countries, on approximately 60 sites:
Austria, Belgium, Czech Republic, Estonia,
Germany, Greece, Hungary (5 sites),
Israel, Poland, Romania, Spain, Ukraine
Rituximab

13. BIOSIMILAR PEGFILGRASTIM DEVELOPMENT BY RICHTER
 Mechanism of action: granulocyte colony stimulating factor
 Reference product: Neulasta®, Amgen
 Main indications: neutropenia
 Comparative efficacy, safety and immunogenicity study in 8
countries, on approximately 40 sites: Bulgaria, Croatia, Czech
Republic, Hungary (9 sites), Romania, Russia, Serbia,
Ukraine
Pegfilgrastim

14. CARIPRAZINE (VRAYLAR)
 Oral, once daily atypical antipsychotic for the
treatment of CNS disorders
 Discovered by Richter researchers, developed jointly with Forest
Laboratories (Allergan)
 Positive topline results in January 2015: schizophrenia – relapse prevention
 Positive topline results in January 2015: schizophrenia – negative symptoms
 17 September 2015: FDA approval in schizophrenia and bipolar I disorder
 March 2016: Available in the US
 March 2016: European application under evaluation by EMA

15. Multiple indications
• Schizophrenia
• Predominant negative symptoms in schizophrenia
• Bipolar mania
• Schizophrenia relapse prevention
• Adjunctive treatment of major depressive disorder
• Bipolar depression
11 years of development
42 clinical study on 4 continents in 26 countries in 1,200 study centers
More than 9,300 enrolled patients/subject
15
CARIPRAZINE (VRAYLAR) DEVELOPMENT

16. VRAYLAR FDA APPROVAL – MEDIA PICKUP

17. SUMMARY OF CARIPRAZINE CLINICAL STUDIES
Mitsubishi
Tanabe
Pharma
Allergan + Richter
Richter

18. Thank you for your attention!