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1 ç 3 Ðåñßïäïò ï 1 Ôåý ïò ÉáíïõÜñéïò - Áðñßëéïò 2014 rd 3 Period st 1 ISSUE January - April 2014 åëëçíéêç Archeia Pharmakeftikis

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3 åëëçíéêç ÁÑ ÅÉÁ ÖÁÑÌÁÊÅÕÔÉÊÇÓ ARCHEIA PHARMAKEFTIKIS ÄÉÅÕÈÕÍÔÇÓ ÓÕÍÔÁÎÇÓ: Ê. ÄÅÌÅÔÆÏÓ ÊáèçãçôÞò ÔìÞìáôïò ÖáñìáêåõôéêÞò, Å.Ê.Ð.Á., EDITOR IN CHIEF: C. DEMETZOS Professor, Faculty of Pharmacy, University of Athens, ÓÕÍÔÁÊÔÉÊÇ ÅÐÉÔÑÏÐÇ: Á.ÔÓÁÍÔÉËÇ ÊÁÊÏÕËÉÄÏÕ ÊáèçãÞôñéá ÔìÞìáôïò ÖáñìáêåõôéêÞò, Å.Ê.Ð.Á ÔÆ. ÁÔÔÁ-ÐÏËÉÔÏÕ Áí. ÊáèçãÞôñéá ÔìÞìáôïò çìåßáò, Å.Ê.Ð.Á. É. ÇÍÏÕ ÊáèçãÞôñéá ÔìÞìáôïò ÖáñìáêåõôéêÞò, Å.Ê.Ð.Á. Å. ÓÊÁËÔÓÁ ÊáèçãÞôñéá ÔìÞìáôïò ÖáñìáêåõôéêÞò, Å.Ê.Ð.Á. Ó. ÁÔÆÇÁÍÔÙÍÉÏÕ Åð. ÊáèçãÞôñéá ÔìÞìáôïò ÖáñìáêåõôéêÞò, ÐáíåðéóôÞìéï Ðáôñþí Ì.ÊÁÐÅÔÁÍÉÄÏÕ ÐñïúóôáìÝíç Áîéïëüãçóçò Ëïéðþí Ðñïúüíôùí, ÅÏÖ Ã.-Ð. ÌÐÏÓÊÏÐÏÕËÏÓ Öáñìáêïðïéüò, Óýìâïõëïò Åðé åéñþóåùí É.ÐÁÐÁÄÏÐÏÕËÏÓ Öáñìáêïðïéüò, Ïéêïíïìïëüãïò Õãåßáò, Õð. ÄéäÜêôùñ, Å.Ê.Ð.Á EDITORIAL BOARD: A. TSANTILI KAKOULIDOU Professor, Faculty of Pharmacy, University of Athens J. ATTA-POLITOU Associate Professor, Faculty of Chemistry, University of Athens I. CHINOU Professor, Faculty of Pharmacy, University of Athens E. SKALTSA Professor, Faculty of Pharmacy, University of Athens S. HATZIANTONIOU Assistant Professor, Faculty of Pharmacy, University of Patras M. KAPETANIDOU Pharmacist, National Organization for Medicines G.-P. BOSCOPOULOS Pharmacist, Business Consultant G. PAPADOPOULOS Pharmacist, Health Economist, PhD Candidate, University of Athens Ãéá õðïâïëþ åñãáóéþí, Õðåýèõíç ¾ëçò: êá Öïßâç ÊáñáïõëÜíç ôçë Ó åäéáóìüò Åíôýðïõ: êá Ìáñßôá ÌáíôÜëá ôçë For manuscript submission, Magazine Features Editor : Mrs Fivi Karaoulani tel Artwork: Mrs Marita Mantala tel ZITA CONGRESS & TRAVEL 1ï ëì. Ëåùö. Ðáéáíßáò Ìáñêïðïýëïõ, Ðáéáíßá, ô.ê T: F: ZITA C O N G R E S S & TRAVEL ISO ISO ZITA CONGRESS & TRAVEL 1st km Peanias-Markopoulo Ave , Peania, Attica, Greece tel: fax:

4 ÐÅÑÉÅ ÏÌÅÍÁ CONTENTS Costas Demetzos The excellence of Pharmaceutical Sciences in Greece through statistics 7-11 Konstantinos Efthymiopoulos The 2013 Vintage Year of New Medicines in Europe and in the USA Nikos Th. Kolman New Drugs Horizon Giannis Papadopoulos The importance of pharmacoeconomics for the health system Natassa Pippa, Apostolos Papachristos, Costas Demetzos Pharmakopoieia-Pharmakotechnia The book of Prof. Emmanuel Emmanuel.An overview Activities 28-29

5 åëëçíéêç Archeia Pharmakeftikis Professor Costas Demetzos President of Hellenic Pharmaceutical Society (H.P.S) Editor- in - Chief of the Journal 'Archeia Pharmakeftikis ÊáèçãçôÞò Êùíóôáíôßíïò Í. ÄåìÝôæïò Ðñüåäñïò ôçò ÅëëçíéêÞò ÖáñìáêåõôéêÞò Åôáéñåßáò (Å.Ö.Å) ÄéåõèõíôÞò óýíôáîçò ôïõ ðåñéïäéêïý 'Áñ åßá ÖáñìáêåõôéêÞò Dear colleagues, After a long period of silence, the Journal Archeia Pharmakeftikis which is the official Journal of the Hellenic Pharmaceutical Society (H.P.S), is re-published in electronic version. The Journal Archeia Pharmakeftikis is the official representative Journal of Greek Pharmacists, which promotes the pharmaceutical scientific activities in Greece and in Europe. The journal has offered for many decades a lot of scientific publications in Pharmaceutical sciences. I am st really proud to welcome the 1 issue of the electronic version of the journal and it is a great honor for me to become the Editor in- Chief of this traditional Journal. Our Journal aspires to cover the gap between the conventional experimental scientific contributions in pharmaceutical sciences and the new insights, including health care policies. Research papers on drug discovery and development, opinions for improving pharmaceutical systems, evolutions of health care systems, news from Pharmaceutical Industry, will be published in our Journal. Furthermore, our Journal can accept commentary papers which promote strategic plans mainly in the European environment, articles describing the evolution approaches in innovative drugs and therapeutic outcomes, regulation issues from the National and European agencies for drug approval, as well as short research communications on specific scientific approaches presenting new and unpublished experimental results. Contributors from the European Societies such as EUFEPS, FIP as well as EFPIA and members from National Pharmaceutical Societies, are all welcome to offer their experience and knowledge from their activities, decisions and behavior which can influence the pharmaceutical sciences and their applications in the society. I hope the Journal Archeia Pharmakeftikis to become a leader opinion in pharmaceutical sciences and I wish a lot of success to the new electronic edition. Áãáðçôïß óõíüäåëöïé, ÌåôÜ áðï ñüíéá, ôï åðßóçìï åðéóôçìïíéêü ðåñéïäéêü ôçò ÅëëçíéêÞò ÖáñìáêåõôéêÞò Åôáéñåßáò (Å.Ö.Å), 'Áñ åßá ÖáñìáêåõôéêÞò', åðáíåêäßäåôáé óôçí çëåêôñïíéêþ ôïõ ìïñöþ. Ôï ðåñéïäéêü Ý åé ùò óôü ï ôçí ðñïâïëþ ôùí åðéóôçìïíéêþí äñáó ôçñéïôþôùí ôçò åëëçíéêþò öáñìáêåõôéêþò êïéíüôçôáò, áëëü êáé ôùí åðéôåõãìüôùí óôï þñï ôçò öáñìáêåõôéêþò Ýñåõíáò êáé áíüðôõîçò íýùí öáñìüêùí, óå åõñùðáúêü åðßðåäï. Ôï ðåñéïäéêü ìáò öéëïäïîåß íá êáëýøåé èåìáôïëïãßá ðïõ áöïñü óôéò íýåò ðñïóåããßóåéò óôéò öáñìáêåõôéêýò åðéóôþìåò, üðùò, ç öáñìáêåõôéêþ öñïíôßäá, ç Ýñåõíá íýùí öáñìáêïìïñßùí êáé ç áíüðôõîç íýùí öáñìüêùí, êáèþò åðßóçò ðñïôüóåéò ãéá íýåò ðïëéôéêýò óôïí ôïìýá ôçò õãåßáò, áðüøåéò ðïõ áöïñïýí óôçí âåëôßùóç ôùí óõóôçìüôùí õãåßáò êáé óôéò åîåëßîåéò óå áõôü, êáèþò êáé íýá áðï ôçí ÖáñìáêåõôéêÞ Âéïìç áíßá. Åðßóçò ôï ðåñéïäéêü ìáò ìðïñåß íá äå ôåß áñèñïãñáößá ç ïðïßá áöïñü óå åðéóôçìïíéêü Üñèñá, Üñèñá Ýêöñáóçò ãíþìçò ðïõ ó åôßæïíôáé ìå óôñáôçãéêýò óôï åõñùðáúêü ðåñéâüëëïí óôï ôïìýá ôçò õãåßáò, Üñèñá áíáóêüðçóçò, Üñèñá ðïõ ó åôßæïíôáé ìå êáéíïôüìá öáñìáêåõôéêü êáé èåñáðåõôéêü ðñïúüíôá êáèþò êáé áñèñïãñáößá ìå èåìáôïëïãßá ðïõ ó åôßæåôáé ìå ôï ñõèìéóôéêü ðëáßóéï åãêñßóåùò íýùí öáñìüêùí ôüóï óå åèíéêü üóï êáé óå åõñùðáúêü åðßðåäï. ÔÝëïò, ç óõìâïëþ óõíáäýëöùí ìå Üñèñá ðïõ ó åôßæïíôáé ìå ôéò äñáóôçñéüôçôåò ôùí åõñùðáúêþí öáñìáêåõôéêþí åðéóôçìïíéêþí åôáéñåéþí êáé éäéáßôåñá ôùí EUFEPS, FIP êáé EFPIA åßíáé åõðñüóäåêôç êáé ìðïñåß íá ðñïóöýñåé, ìýóá áðü áõôü, ðëçñïöüñçóç ðïõ ó åôßæåôáé ìå ôçí åõñùðáúêþ êáé äéåèíþ åìðåéñßá óôï þñï ôùí öáñìáêåõôéêþí åðéóôçìþí. Åëðßæù êáé åý ïìáé ç åðáíýêäïóç ôïõ éóôïñéêïý áëëü êáé óçìáíôéêïý áõôïý ðåñéïäéêïý ôùí öáñìáêåõôéêþí åðéóôçìþí, íá áðïôåëýóåé ôïí åðéóôçìïíéêü äßáõëï åðéêïéíùíßáò ôüóï ìåôáîý ôùí ìåëþí ôçò Å.Ö.Å, áëëü êáé ìå ôïõò åõñùðáßïõò óõíáäýëöïõò ìáò, ìå óôü ï ôçí ìåãáëýôåñç áëëçëåðßäñáóç ìå áõôïýò êáé ôéò åðéóôçìïíéêýò åôáéñåßåò ôïõò. ÊáëÞ ìáò åðéôõ ßá!

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7 åëëçíéêç Archeia Pharmakeftikis Commentary Article The excellence of Pharmaceutical Sciences in Greece through statistics Costas Demetzos Department of Pharmaceutical Technology, Faculty of Pharmacy, Panepistimioupolis Zografou 15771, University of Athens, Athens, Greece Corresponding Author: Tel.: fax: Summary The purpose of this commentary article is the presentation of scientific excellence in the field of Health Sciences, as the driving force for the development process of Greece. The cooperation in the fields of Health Sciences, the involvement of social partners and the contribution of the approval authorities of medicines, could cause a rational and an effective approach in the development process, beating technocratic and economic standards. This multivariate procedure, is based on excellence in science regarding the Greek scientific community, through stati-stical data, which were obtained from the Greek National Documentation Centre. The contribution of the Greek scientific community, particularly in health, both in proto-type production knowledge, as well as in the level of acce-ptance by the scientific community, exceeds the average total of the corresponding European indicators. Ðåñßëçøç Óêïðüò ôïõ ðáñüíôïò Üñèñïõ åßíáé ç ðáñïõóßáóç ôçò åðéóôçìïíéêþò áñéóôåßáò óôïí ôïìýá ôçò õãåßáò, ùò êéíçôþñéïò äýíáìç ðñïò ôçí áíáðôõîéáêþ ðïñåßá ôçò ÅëëÜäáò. Ç óõíåñãáóßá óôïõò ôïìåßò ôçò õãåßáò, ç óõììåôï Þ ôùí êïéíùíéêþí åôáßñùí êáé ç óõìâïëþ ôùí åãêñéôéêþí áñ þí ôùí öáñìüêùí, ìðïñïýí íáí äçìéïõñãþóïõí ìßá ïñèïëïãéêþ êáé áðïôåëåóìáôéêþ ðñïóýããéóç óôçí áíáðôõîéáêþ ðïñåßá êáé ôçò Åõñþðçò, õðåñâáßíïíôáò ôå íïêñáôéêü êáé ïéêïíïìéêü ðñüôõðá. Ç ðïëõðáñáãïíôéêþ áõôþ äéáäéêáóßá, ìå âüóç ôçí áñéóôåßá óôçí åðéóôþìç üóïí áöïñü óôçí åëëçíéêþ åðéóôçìïíéêþ êïéíüôçôá, áðïäåéêíýåôáé ìýóá áðü ôá óôáôéóôéêü äåäïìýíá, ôá ïðïßá åëþöèçóáí áðü ôï Åèíéêü ÊÝíôñï Ôåêìçñßùóçò (ÅÊÔ). Ç óõìâïëþ ôçò åëëçíéêþò åðéóôçìïíéêþò êïéíüôçôáò, éäéáßôåñá óôï þñï ôçò õãåßáò, ôüóï óå åðßðåäï ðáñáãùãþò ðñùôüôõðçò ãíþóçò, üóï êáé óå åðßðåäï áðïäï Þò áðü ôçí åðéóôçìïíéêþ êïéíüôçôá, õðåñâáßíåé óå ìýóï üñï óõíïëéêü ôïõò áíôßóôïé ïõò åõñùðáúêïýò äåßêôåò. 7

8 The excellence of Pharmaceutical Sciences in Greece through statistics åëëçíéêç 1. Introduction This commentary article aims to address the role of the scientific excellence of innovative medicines as the key element in the development process in Greece. The integration concept between science and society could be a crucial factor that forces regulatory agencies to create more rational oriented regulatory outcomes that can effectively contribute to the development process in the European Union from an economical point of view. This multidisciplinary approach is leading society to become the main partner and the basic regulator in the developing 1 process in the European Union The scientific outcomes are considered beneficial to society in terms that they can provide new approaches for the rationalization of the European health systems and of the pharmaceutical expenditures. The cargo that can transfer these approaches to the European bodies such as the European Commission, the European Parliament and the European Council of Ministers is EUFEPS. EUFEPS is recognized as the opinion leader in pharmaceutics which is able to promote the alliance and to coordinate excellence in Pharmaceutical Sciences, Pharmaceutical Industry and society, on a European level, with regard to the new European environment keeping into account the current economical situation. The new European strategy until 2020 addresses the European Commission paper on 'Innovation Union' [COM final, Communication from the Commission to the European Parliament, the Council, the European economic and social committee and the committee of the regions, Europe 2020 Flagship Initiative Innovation Union, SEC (2010, 1161 Brussels, ]. This is a scenario which promotes the integration between Research, Economics and Environmental policies. An important part in the new European strategy highlighted by the European 2020 strategy as 'smart, sustainable and inclusive growth' constitutes a direction which could offer opportunities to the new generation and a new vision for a real integrated European Union. 2. Excellence in Health Sciences of the Greek scientific community. According to the published review concerning the contribution of the Greek scientific community to the total European scientific activities based on the European project th Research Potential (Specific Programme Capacities- 7 Framework Programme for Research of the European Union) in sectors like Biotechnology and Genetics, Agriculture, Energy and Environment, Technologies, Informatics and Communications, Materials and Life Sciences, Human and 2 Sociological sciences, is considered very successful. We point out that this European program concerns and supports the excellence of research groups which are working in Research Institutes, Universities or in other centers of excellence in research (i.e. pharmaceutical industries etc.) in the borders [geographical and economical periphery (GEP)] of the European Union. The vision of this action is to promote A the integration between the European Union and GEP countries and to produce an integrated scientific environment. This project named Research Potential th (Specific Programme Capacities- 7 Framework Programme for Research of the European Union) is part of the FP7 European project accounting funds of 340 million euro for the period The main action of this project (i.e. 7 Capacities) was REGPOT-1 which supports the excellence of research groups, in order to integrate scientific actions running in the GEP countries of the EU. According to the SWOT analysis which promotes Strengths, Weaknesses, Opportunities and Threats, a strategy was developed in order to finance and support scientific infrastructures, human resources, networking and providers, promotion of the scientific results and Intellectual property. A detailed analysis concerning the Greek scientific status- in order to support the role of Greece in a bio-better Europe - showed that, in the sector of Health Sciences, Greek scientific projects cover 44,11%, 52.9% in the sector of Physics and Mechanism and a percentage of 2,94% of the Social economical and human sciences. More detailed, 60% out of 44.11% of the projects realized in the Health Sciences' sector, are preceded by Research Institutes and 40% by Universities. Similarly, 44.5% out of 52.9% in the Physics and Mechanism sector are realized by Research Institutes and 55.5% by Universities. To the best of our knowledge, the published results on the sector of Health Science showed an excellent contribution of the Greek scientific groups in literature. The European Research Council (ERC) has also gained a central place in the Europe 2020 strategy for growth and in the Innovation Union Strategy for promoting Europe's economic recovery, global competiveness and social 1. This terminology is proposed by the author A. Geographical and Economical Periphery 8

9 åëëçíéêç Archeia Pharmakeftikis Sciences domain and 79 (11%) to the Social Sciences and 3 Humanities domain (Fig. 1a). From now on, 'Greek Proposals' refers to ERC applications submitted by Greek Host Institutions. Fig. 1b compares the overall Greek success rates per ERC call and shows their evolution. In the Starting Grant calls, the overall Greek success rates displayed a significant increase from the first to the third call where both success rates reached their maximum of 16% and 8%, respectively. In the Advanced Grant calls, the overall Greek success rates do not follow the same pattern: while the overall success rate reached its maximum in the 2nd call (16%), the Greek success rate attained its peak in the fourth call (8%). The Greek average success rate is about three times lower than the total average success rate and one of the lowest among ERA countries. However, in the last two calls of both funding schemes, this ratio has significantly decreased, from three to about two times lower. Fig. 1a. Number (& %) of Greek proposals submitted & evaluated per domain and ERC funding scheme. A similar pattern in the evolution of the number and the percentage of Greek applications to that of ERC applications per call and the grant scheme are presented in Fig. 1b. As in the rest of the EU and Associated Countries, there is a significant drop in Greek applications of 74% and 69% between the first and second ERC, Starting and Advanced calls, respectively. There is also a recovery in Advanced Grant applications from 2010 with an increase in Greek submissions of 33% and 42% between the second and third calls and between the third and fourth calls, respectively. However, the Starting funding scheme still exhibits a significant decrease of 58% in Greek applications between the second and third calls and the recovery did not materialize until the fourth call, which saw an increase in Greek submissions of 94% compared 4 to the previous years. The establishment of benchmark features related to the profile of the applicant (Principal Investigator) incorporated in order to encourage ambitious prosperity. Furthermore, Greece has submitted 720 proposals that have been evaluated, representing the 2,8% of ERC applications reviewed. 72% (518 proposals) and 28% (202 proposals) of the Greek applications were addressed to Fig. 1b. Overall and Greek success rates per ERC call (ERC Grants in Greek His per call). [Adapted from 3] the Starting and advanced funding schemes, respectively. 406 proposals (56% of Greek applications) were submitted to the Physical Sciences and Engineering domain, 235 (33%) to the Life Sciences domain and 79 (11%) to the Social Sciences 3 and Humanities domain (Fig. 1a). From now on, 'Greek Proposals' refers to ERC applications submitted by Greek Host Institutions. Fig. 1b compares the overall Greek success rates per ERC call and shows their evolution. In the Starting Grant calls, the overall Greek success rates displayed a significant increase from the first to the third call where both success rates reached their maximum of 16% and 8%, respectively. In the Advanced Grant calls, the overall Greek success rates do not follow the same pattern: while the overall success rate reached its maximum in the 2nd call (16%), the Greek success rate attained its peak in the fourth call (8%). The Greek average success rate is about three times lower than the total average success rate and one of the lowest among ERA countries. However, in the last two calls of both funding schemes, this ratio has significantly decreased, from three to about two times lower. A similar pattern in the evolution of the number and the percentage of Greek applications to that of ERC applica-tions per call and the grant scheme are presented in Fig. 1b. As in the rest of the EU and Associated Countries, there is a significant drop in Greek applications of 74% and 69% between the first and second ERC, Starting and Advanced calls, respectively. There is also a recovery in Advanced Grant applications from 2010 with an increase in Greek submissions of 33% and 42% between the second and third calls and between the third and fourth calls, respectively. However, the Starting funding scheme still exhibits a significant decrease of 58% in Greek applications 9

10 The excellence of Pharmaceutical Sciences in Greece through statistics åëëçíéêç between the second and third calls and the recovery did not materialize until the fourth call, which saw an increase in 4 Greek submissions of 94% compared to the previous years. The establishment of benchmark features related to the profile of the applicant (Principal Investigator) incorporated in order to encourage ambitious proposals and researchers at the right competitive level, together with the low Greek success rate, seems to have significantly discouraged Greek participation in ERC Grant calls. The number of Greek publications of the eight thematic categories of Biosciences for the period are presented in Fig. 2a. On the other hand, in Fig. 2b, the number of publications, the number of citations and the normalized relevant impact indicator of publications included in the eight thematic categories in relation to publications worldwide on the same topic categories of Life Sciences for the period , are 4 presented in a very comprehensive way. Fig. 2b. Number of publications, number of citations and normalized relevant impact indicator of publications included in the eight thematic categories in relation to publications worldwide on the same topic categories of Life Sciences for the period [Adapted from 4] Fig. 2a. Number of Greek publications of the eight thematic categories of Biosciences for the period One of the main objectives of the ERC is to enhance the ability of Europe to retain and repatriate the best researchers in Europe as well as to attract talents from abroad. According to the statistical data that are presented in Fig. 3 (a and b), Greek scientists occupy an important position in the number of publications and they are considered to have a great impact on the international scientific community, especially in biosciences as indicated by bibliometric analysis of Greek 2 publications in a scientific journal (Fig. 4). According to National Science Indicators, the data base of scientific publications, 2010 recorded 10,219 Greek scientific publications in international journals indexes system Web of Science. This number is slightly reduced compared to 2009 ( publications) and 2008 ( publications). Fig. 3a. The Number of publications and the coefficient of variation for Greek research activity Fig. 3b. The Greek publications. [Adapted from 5] 10

11 åëëçíéêç Archeia Pharmakeftikis conclusion, the purpose of the present work is to highlight the role of Greek excellence in science for developing a communication channel on a European level that would flatten the economic diversification and would focus only on the common aspiration of producing innovative medicines with the aim of Public Health. Fig. 4a. Relative impact indicator of Greek publications in relation to the posts of the member countries of the EU and OECD every five years for the period Acknowledgements The author would like to thank Prof. Lennart Dencker (past president of EUFEPS) for his valuable comments and suggestions to improve this article as well as Mr. Magaritis Proedrou from the National Documentation Centre (EKT) for his contribution in the collection of all the statistical data included in this review article. Fig. 4c. Share (%) of puplications Fig. 4b. Breakdown of Greek publications in the six main scientific fields for the five years from 2004 to Conclusions The aim of this commentary article was to address the role of scientific excellence and to underline that innovations in science and technology could be the key element for the development process in Greece and in Europe as well as in the geographical and economical peripheral countries (GEP) in the European landscape. As development is the main demand, science and technology, mainly in health, could be the driving forces for the economical and social developments and for the improvements in the European social reimbursement health systems. The development of a bio-better Europe based on scientific and technological inspirations could be considered as an interplay approach between GEP countries and even between the north and west located countries in the European landscape. In Fig. 4c. Share (%) of publications. [Adapted from 5] References 1. Gaspar R., Aksu B., Cuine A., Danhof M., Takac M.J., Linden H.H., Link A., Muchitsch E.M., Wilson C.G., Ohrngren P., DenckerL. Towards a European strategy for medicines research ( ): The EUFEPS position paper on Horizon Eur. J. Pharm. Sci. 47: , Tzenou G., Malliou N., Sachini E. Scientific excellence in EU convergence regions, : the case of Greece. National Documentation Centre (in Greek) Pascual C., Sachini E. 5 years of Excellence in the European Research Area : the case of Greece. National Documentation Centre Sachini E., Malliou N. Houssos N., Greek Scientific Publications : Á Bibliometric analysis of Greek publications in international scientific journals. National Documentation Centre Sachini E., Malliou N. Houssos N., Karaiskos, D. Greek Scientific Publications in the field of Natural Sciences (in Greek). National Documentation Centre

12 åëëçíéêç Archeia Pharmakeftikis PERSPECTIVES: News and views on innovative therapies The 2013 Vintage Year of New Medicines in Europe and in the USA Konstantinos Efthymiopoulos PLUS Life Sciences Consulting Parc Château Banquet 14, 1202 Geneva, Switzerland Corresponding author: Konstantinos Efthymiopoulos Ðåñßëçøç Óôï Üñèñï ãßíåôáé ìéá áíáóêüðçóç ôùí íýùí öáñìüêùí ðïõ ðþñáí Ýãêñéóç áðü ôçí ÁìåñéêáíéêÞ Õðçñåóßá ÖáñìÜêùí êáé Ôñïößìùí (FDA) Þ èåôéêþ åéóþãçóç áðü ôçí ÅõñùðáúêÞ ÅðéôñïðÞ ãéá ôá ÖáñìáêåõôéêÜ Ðñïúüíôá ãéá Áíèñþðéíç ñþóç (CHMP) êáôü ôç äéüñêåéá ôïõ ÓõíïëéêÜ ìýóá óôï 2013 ç CHMP Ýêáíå èåôéêþ åéóþãçóç ãéá 81 íýá öüñìáêá åíþ ç FDA åíýêñéíå ôçí êõêëïöïñßá 27 íýùí öáñìüêùí óôï ßäéï ñïíéêü äéüóôçìá. Ôá íýá öüñìáêá ðïõ ðþñáí êáé Ýãêñéóç áðü ôçí FDA êáé èåôéêþ åéóþãçóç áðü ôçí CHMP ìýóá óôï 2013 åßíáé óõíïëéêü 13. Áðü ôá 81 íýá öüñìáêá ðïõ ðþñáí èåôéêþ åéóþãçóç áðü ôçí CHMP, ôá 38 åß áí äñáóôéêýò ïõóßåò ðïõ Ýðáéñíáí Ýãêñéóç ãéá ðñþôç öüñá, ôá 20 Þôáí ãåíüóçìá åíþ ôýóóåñá Þôáí âéï-ïìïåéäþ. Ç óïäåéü ôïõ 2013 äåí ðåñéëáìâüíåé ìåãüëåò åêðëþîåéò Þ óçìáíôéêýò äéáöïñïðïéþóåéò ó åôéêü ìå ôéò ðñïçãïýìåíåò ñïíéýò. ÐïóïôéêÜ åßíáé ãåíéêü êïíôü óôïí ìýóïí üñï ôùí ðñüóöáôùí åôþí. Ç ìåãüëç ðëåéïøçößá ôùí íýùí öáñìüêùí åßíáé çìéêü ìüñéá, õðüñ ïõí åðßóçò Ýíá ñáäéïöüñìáêï êáé ôñßá äéáãíùóôéêü. Ç ëßóôá ðåñéëáìâüíåé åðßóçò ôá ðñþôá äýï âéï-ïìïåéäþ áíôéóþìáôá óôçí ÅõñùðáúêÞ íùóç (êáé ôá äýï áíôßãñáöá ôïõ infliximab) êáèþò êáé ôï ðñþôï èåñáðåõôéêü åìâüëéï óôçí ÅõñùðáúêÞ íùóç (åíäåßêíõôáé óôç èåñáðåßá ôïõ êáñêßíïõ ôïõ ðñïóôüôç êáé åß å Þäç åãêñéèåß óôçí ÁìåñéêÞ ôï 2012). íáò éäéáßôåñá óçìáíôéêüò áñéèìüò ôùí íýùí èåñáðåéþí åßíáé óôáèåñïß óõíäõáóìïß äñáóôéêþí ïõóéþí åíþ åðßóçò óçìáíôéêüò åßíáé êáé ï áñéèìüò ôùí ëåãüìåíùí ïñöáíþí öáñìüêùí (14 óõíïëéêü), åðéâåâáéþíïíôáò Ýôóé ôéò ôüóåéò ðïõ ðáñáôçñþèçêáí ôá ôåëåõôáßá ñüíéá. Ïé èåñáðåõôéêýò êáôçãïñßåò ìå ôá ðåñéóóüôåñá íýá öüñìáêá åßíáé åðßóçò ïé óõíþèåéò: ïãêïëïãßá, áíáðíåõóôéêü, äéáâþôçò ôýðïõ 2, áíôé-ééêü. Ðåñßðïõ ôï Ýíá ôñßôï áðü ôéò íýåò äñáóôéêýò ïõóßåò åßíáé öüñìáêá ðïõ åßíáé ôá ðñþôá óå êáéíïýñãéåò êáôçãïñßåò öáñìüêùí, äåß íïíôáò Ýôóé üôé ï âáèìüò êáéíïôïìßáò ðáñáìýíåé õøçëüò. ÁñêåôÜ áðü áõôü ôá öüñìáêá åêôéìüôáé üôé èá êáôáöýñïõí åôþóéåò ðùëþóåéò ðïõ èá îåðåñüóïõí ôï Ýíá äéóåêáôïììýñéï. Key Words: FDA, EMA, 2013, New Drug Approvals 12

13 The 2013 Vintage Year of New Medicines in Europe and in the USA åëëçíéêç This paper will review the new drug approvals in Europe and in the USA during As it turned out, 2013 has been a good vintage year for the approvals of new therapies in particular in Europe. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) recommended a total of 81 medicines for human use for marketing authorisation, compared with just 57 in 2012, but similar to that in 2011 (see Fig. 1). Close to half of these medicines (38 out of the 81) were containing a new active substance, a number which is similar to that of 2012 (35 new active substances) and significantly higher than that of previous years (25 in 2011 and 15 in 2010). About a quarter of the medicines approved in 2013 were generics, a number which is similar to that in 2012 but generally lower than in the last few years (eg. 45 in 2010 or 57 in 2009). Interestingly, the number of orphan medicines with a positive CHMP opinion in 2013 grew further, compared to the recent past, reaching a total of 11. Furthermore, the vintage year 2013 of the CHMP positive recommendations includes two new advanced therapy medicinal products (ATMPs) and four biosimilars. Since the start of the related legislation, only two other ATMPs have been approved (the first in 2009 and a second in 2012) and only one biosimilar (in 2010). Fig. 1: Number of medicines that received a positive opinion by the CHMP in the last five years. The US Food and Drugs Administration (FDA) has approved 27 novel new medicines (new molecular entities, NMEs) in 2017, a number which is lower to that in 2012 (39 NMEs) but similar to recent past years (see Fig. 2). Interestingly, one third of the NMEs approved in 2013 were orphan drugs, as it was also the case in Furthermore, also one third of the NMEs approved in 2013 were First-in-Class (ie with a novel mechanism of action), while the percentage of Fist-in-Class NMEs in 2012 was even higher (51%). Table 1 shows the compounds that received both an FDA approval and a positive CHMP opinion during All of them (except Kadcyla) are small molecules, while Xofigo is a radiopharmaceutical. They spread across various therapeutic indications with two of them (macitentan, and pomalidomide) having an orphan drug status by both the FDA and the EMA, while afatinib and dabrafenib have orphan designation only by the FDA. On the other side of the spectrum, compounds such as the combination of vilanterol and fluticasone, vortioxetine or sofosbuvir and others are expected to become blockbusters (drugs with annual sales over $1 billion). The list includes examples of all the trends currently visible in drug development: there are first-in-class molecules (like canagliflozin), combinations of active ingredients (like vilanterol and fluticasone), new indications for old compounds (like dimethyl fumarate). It is worth highlighting Sovaldi as the first interferon-free treatment option for hepatitis C, which constitutes a major breakthrough in the treatment of this disease (but also as a therapy that has been priced very highly at $84'000 per 12- week treatment course and will make Sovaldi a blockbuster already in its first year in the market). An interesting feature of Brintellix is that, in addition to its effects on depression, it also has positive effects on cognition. Gilotrif is an example of a drug that is better used with a companion diagnostic; as afatinib works by blocking specific types of the epidermal growth factor receptor (EGFR), identification of patients whose lung cancer cells express EGFR through the use of related diagnostics allows a targeted use of the drug. Both canagliflozin and alogliptin are indicated for the treatment of type 2 diabetes, but they have a different mechanism of action (SGLT2 inhibitor and DPP-4 inhibitor, respectively); alogliptin will also be used in combination with metformin or pioglitazone. Kadcyla is an example of the relatively recent trend of antibody-drug conjugates (ADC); the specificity of trastuzumab for HER-2 allows the targeted delivery of the toxin mertansin thus increasing greatly the therapeutic index of the treatment. Table 2 shows the remaining medicines that got approval by the FDA in Of these, all (except obinutuzumab) are small molecules, and two (eslicarbazepine and gadoterate meglumine) have already been approved in Europe. The list includes three diagnostics (Dotarem, Lymphoseek and Vizamyl) and five drugs with orphan designation (Adempas, Gazyva, Imbruvica, Kynamro and Mekinist). Anoro Ellipta was the second drug combination for COPD from GSK that was approved in 2013, reflecting GSK's dominant position in this 13

14 åëëçíéêç Archeia Pharmakeftikis Fig. 2: Number of new molecular entities (NMEs) that were approved by the FDA in the last five years. indication; the proprietary Ellipta drug powder inhaler is also used here. Mekinist is another double hit (two drugs approved for the same indication) for GSK in 2013, in this case for melanoma (the other compound approved is Tafinlar, shown in Table 1); the company is also pursuing a combination of these two drugs as well as a combination of mekinist with Pfizer's palbociclib. Gazyva is targeting CD20 (like Rituxan) and has benefited from a breakthrough therapy designation by the FDA as did Imbruvica, which is expected to become a new standard in leukemia therapy and a blockbuster drug in terms of sales. Compound (INN) Company Indication Breo Ellipta/Revlar Ellipta (vilanterol & chronic obstructive GSK/Theravance fluticasone furoate) pulmonary disease Brintellix (vortioxetine) Lundbeck /Takeda major depressive episodes Gilotrif (afatinib) Boehringer Ingelheim non-small cell lung cancer Invokana (canagliflozin) J&J type-2 diabetes Kadcyla (trastuzumab emtansine) Roche/ImmunoGen breast cancer Nesina/Vipidia (alogliptin) Takeda type 2 diabetes Opsumit (macitentan) Actelion pulmonary arterial hypertension Pomalys/Imnovid (pomalidomide) Celgene multiple myeloma Sovaldi (sofosbuvir) Gilead hepatitis C virus infection Tafinlar (dabrafenib) GSK metastatic melanoma Tecfidera (dimethyl fumarate) Biogen Idec multiple sclerosis Tivicay (dolutegravir) GSK & Pfizer Joint Venture (ViiV Healthcare) HIV infection Xofigo (radium-223) Bayer prostate cancer Table 1: New medicines that received both an FDA approval and a CHMP positive recommendation in 2013 [compounds shown in italics have orphan status; afatinib and dabrafenib have orphan designation only in the USA]. The four biosimilars that received positive CHMP recommendation in 2013 are listed in Table 3. Among them are the first two biosimilar antibodies (both infliximab biosimilars). A pegylated version of filgrastim (Lonquex, by Teva) is listed together with other new medicines in Table 5 The nine orphan drugs that received positive CHMP recommendation in 2013 are listed in Table 4 (and together with the orphan drugs listed in Table 1 bring the total of theorphan drugs with a positive CHMP recommendation in Compound (INN) Company Indication Adempas (riociguat) Bayer pulmonary hypertension Anoro Ellipta (umeclidinium & vilanterol) GSK/Theravance chronic obstructive pulmonary disease Aptiom (eslicarbazepine acetate) Sunovion Pharmaceuticals epilepsy Dotarem (gadoterate meglumine) Guerbet MRI; brain and spine moderate-to-severe Duavee (conjugated estrogens/ Pfizer/Ligand vasomotor symptoms & bazedoxifene) Pharmaceuticals osteoporosis Gazyva (obinutuzumab) Roche /Biogen Idec chronic lymphocytic leukemia Imbruvica (ibrutinib) Pharmacyclics/J&J mantle cell lymphoma Kynamro (mipomersen) Sanofi/Isis homozygous familial hypercholesterolemia Luzu (luliconazole) Valeant /Topica Pharmaceuticals fungal infections Lymphoseek (Tc 99m tilmanocept) Navidea Biopharmaceuticals / Cardinal Health Table 2: Other new medicines that received FDA approval in 2013 [compounds shown in italics have orphan status]. breast cancer/melanoma diagnostic Mekinist (trametinib) GSK melanoma Olysio (simeprevir) Medivir / Janssen (J&J) Hepatitis C Infections Osphena (ospemifene) Shionogi /QuatRx Pharmaceuticals Dyspareunia (painful intercourse) Vizamyl (flutemetamol F18 injection) GE Healthcare Beta amyloid imaging diagnostic (AD, dementia) 2013 to 11). It is worth noting that three of them are to treat malaria. Inclusig's authorization was temporarily suspended in 2013 while some safety findings were assessed but the drug eventually resurfaced although with a more restricted label. Lojuxta's positive recommendation by the CHMP followed the FDA approval that was granted in Compound (INN) Company Indication Grastofil (filgrastim) Apotex neutropenia Inflectra(infliximab) Hospira various inflammatory conditions (RA, psoriasis, IBD, etc) Ovaleap (follitropin alpha) Teva fertility disorders Remsina (infliximab) Celltrion Healthcare various inflammatory conditions (RA, psoriasis, IBD, etc) Table 3: Biosimilar medicines that received a positive opinion from the CHMP in Compound (INN) Company Indication Bosulif (bosutinib) Pfizer chronic myelogenus leukemia Cholic Acid FGK (cholic acid) FGK Representative Service inborn errors of primary bile acid synthesis Cometriq (cabozantinib) TMC Pharma Services medullary thyroid cancer Deltyba (delamanid) Otsuka multidrug-resistant tuberculosis Iclusig (ponatinib) Ariad leukaemia Lojuxta (lomitapide) Aegerion homozygous familial hypercholesterolaemia Para-aminosalicylic acid Lucane (paraaminosalicylic acid) tuberculosis multidrug-resistant Lucane Procysbi (mercaptamine) Raptor Pharmaceuticals nephropathic cystinosis Sirturo (bedaquiline) Janssen-Cilag multidrug-resistant tuberculosis Table 4: New medicines with orphan status that received a positive opinion from the CHMP in Table 5 shows the vaccines that received positive CHMP recommendation in It is worth highlighting Provenge, an advanced-therapy medicinal product (ATMP) and the only (so far) therapeutic vaccine in the market (it is indicated against metastatic prostate cancer). 14

15 The 2013 Vintage Year of New Medicines in Europe and in the USA åëëçíéêç Compound (INN) Company Indication Fluenz Tetra (influenza vaccine) MedImmune influenza prophylaxis Hexacima & Hexyon Sanofi Pasteur diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type B vaccin Imvanex (modified vaccinia Ankara virus) Bavarian Nordic smallpox infection vaccine Provenge [advanced therapy product containing autologous mononuclear cells] Dendreon metastatic prostate cancer Table 5: Vaccines that received a positive opinion from the CHMP in Finally, Table 6 shows the remaining medicines that got a positive opinion from the CHMP in Among them are quite a few combination products and one diagnostic (Neuraceq, that detects -amyloid in the brain). Maci (matrixinduced autologous chondrocyte implantation) is an ATMP and is the first combined tissue-engineered medicine to be authorised across the European Union (EU). Another first is Nuedexta, which is the first medicine for pseudobulbar affect approved in the EU. Overall the 2013 vintage year of new medicines in Europe and in the USA is quantitatively consistent with the average number of new medications authorized each year and is biased towards oncology, diabetes, respiratory and virology as it has been the case in the recent past. It also confirms trends that have started emerging, such as the increasing number of medicines that have orphan drug status, the number of fixed drug combinations or the number of biosimilars. It is encouraging that quite a few of the new medicines are first-in-class or the first drugs approved in their indication, suggesting that innovation remains a driver. The fact that a good number of the medicines in the 2013 vintage year are expected to reach blockbuster status is also positive, as it should help to generate the resources that are necessary in order to maintain high levels of innovation in drug discovery and health care. Sources of information: EMA recommends 81 medicines for marketing authorisation in 2013, Press release issued by the EMA on th January 20, 2014 [http://www.ema.europa.eu/ema/index.jsp?curl=pages/ne ws_and_events/news/2014/01/news_detail_ jsp&m id=wc0b01ac058004d5c1]. CHMP Meeting Highlights (January-December 2013) published monthly in EMA's web site [http://www.ema.europa.eu/ema/index.jsp?curl=pages/abo Compound (INN) Company Indication Abilify Maintena (aripiprazole) Otsuka schizophrenia Aubagio (teriflunomide) Sanofi relapsing-remitting multiple sclerosis Cholib (fenofibrate / simvastatine) Abbott abnormal levels of cholesterol and fat in the blood Erivedge (vismodegib) Roche advanced basal-cell carcinoma Evarrest (human fibrinogen / human thrombin) Omrix blood loss during surgery primary immunodeficiency HyQvia (human normal Baxter syndromes and secondary immunoglobulin) hypogammaglobulinemia Incresync (alogliptin / pioglitazone) Takeda type 2 diabetes Izba (travoprost) Alcon ocular hypertension/ open angle glaucoma Jetrea (ocriplasmin) ThromboGenics symptomatic vitreomacular adhesion Lemtrada (alemtuzumab) Genzyme relapsing-remitting multiple sclerosis Lidocaine/Prilocaine Plethora (lidocaine and prilocaine) Plethora Solutions premature ejaculation Lonquex (lipegfilgrastim) Teva chemotherapy-induced neutropenia Maci (autologous cultured symptomatic cartilage Genzyme chondrocytes) defects of the knee Mirvaso (brimonidine) Galderma facial erythema of rosacea Neuraceq (florbetaben (18F)) Piramal Imaging Detection of â-amyloid in the brain NovoEight (turoctocog alfa) Novo Nordisk haemophilia A Nuedexta (dextromethorphan Jenson Pharmaceutical hydrobromide / quinidine sulfate) Services pseudobulbar affect Somatropin Biopartners (somatropin) BioPartners growth failure Spedra (avanafil) Vivus erectile dysfunction Stivarga (regorafenib) Bayer metastatic colorectal cancer Stribild (elvitegravir / cobicistat / emtricitabine / tenofovir disproxil) Gilead HIV infection Tybost (cobicistat) Gilead HIV infection in combination with atazanavir and darunavir Vipdomet (alogliptin / metformin) Takeda type-2 diabetes Vipidia (alogliptin) Takeda type-2 diabetes Vitekta (elvitegravir) Gilead HIV-1 infection Voncento (human coagulation factor VIII / Von Willebrand factor) Xigduo (dapagliflozin and metformin) Xoterna Breezhaler and Ultibro Breezhaler (indacaterol / CLS Behring Bristol-Myers Squibb / AstraZeneca Novartis Europharm haemophilia A and Von Willebrand disease type 2 diabetes chronic obstructive pulmonary disease Table 6: Other new medicines that received a positive opinion from the CHMP in ut_us/document_listing/document_listing_ jsp&mi d=wc0b01ac d2a]. Medicinal Products for Human Use: Monthly Fith gures January 2014, published on February 25, 2014 by the EMA [http://www.ema.europa.eu/docs/en_gb/document_librar y/report/2014/02/wc pdf] Novel New Drugs Summary, issued by the FDA in January 2014.[http://www.fda.gov/downloads/drugs/development approvalprocess/druginnovation/ucm pdf] Novel New Drugs Summary, issued by the FDA in January valprocess/druginnovation/ucm pdf 15

16 åëëçíéêç Archeia Pharmakeftikis PoliHyg21 New Drugs Horizon Íßêïò È. Êüëìáí Corporate Affairs Director Galenica A.E. Åëåõèåñßáò 4, ÊçöéóéÜ Corresponding author: Íßêïò È. Êüëìáí Ðåñßëçøç Äéáíýïõìå ôá ðñþôá ñüíéá ôïõ íýïõ áéþíá, óõíåéäçôïðïéþíôáò ôï ôýëïò åðï Þò ôùí blockbusters. Ôï íýï ðåñéâüëëïí áñáêôçñßæåôáé áðü: á) ÁõîçìÝíï êüóôïò ôùí ñüíéùí áóèåíåéþí ðïõ ïöåßëåôáé êáé óôçí åðéìþêõíóç ôïõ ðñïóäüêéìïõ åðéâßùóçò. â) Ðåñéïñéóìïýò óôïõò ðñïûðïëïãéóìïýò ôùí êõâåñíþóåùí ó åôéêü ìå ôéò äáðüíåò ãéá ôçí õãåßá. ã) ÍÝåò õøçëþò ôå íïëïãßáò êáé èåñáðåõôéêþò áðüäïóçò ðñïóåããßóåéò ðïõ áõîüíïõí áö'åíüò ôéò áðáéôþóåéò ôùí õðçñåóéþí õãåßáò áö'åôýñïõ ôï êüóôïò. Ç öáñìáêåõôéêþ âéïìç áíßá õéïèåôåß óôñáôçãéêýò ãéá ôéò äéáöáéíüìåíåò áõîçìýíåò áíüãêåò. ÌåôÜ áðü ðïëëü ñüíéá Ýñåõíáò êáé áíüðôõîçò, ïé 10 ìåãáëýôåñåò öáñìáêåõôéêýò åôáéñßåò ðñïåôïéìüæïõí ôï ëáíóüñéóìá óêåõáóìüôùí ãéá èåñáðåõôéêýò êáôçãïñßåò üðùò ïãêïëïãßá, êáñäéïëïãßá, äéáâþôçò, íåõñïëïãßá ê.ü. We are running first years of the new century realizing the end of blockbusters period. The new environment is characterized by: a) Increased cost coverage of chronic diseases due to extended life-time duration. b) The budget restrictions of governments on health expenditure. c) New high-tech and therapeutic efficiency approaches that increase on the one hand the health services' requirements and the cost on the other hand. Pharma industry adopts strategies to the upraised needs. After many years R&D of pharma companies, seems that have major products launches coming. Novartis has a selective oral anaplastic lymphoma kinase inhibitor for the lung cancer (ALK positive non-small cell). The company approved Ultibro Breezhaler for COPD and European approval for Fospiro. Also has a candidate drug for treatment of plaque psoriasis, Secukinumab. Pfizer is expected to approve new indication for prevention of D.V.T. for Apixaban. Sanofi approved in E.U. Lemtrada for multiple sclerosis but FDA denied due to safety and efficacy profile of the drug. The second drug for M.S. treatment is teriflunomide showing promising results and has been approved in the U.S. and U.K. Another interesting product is Eliglustat for the treatment of Gaucher disease. Roche approved obinutuzumab for chronic lymphoid leukemia which is a follow-up product to known treatment of many B-cells mallignacies of rituximab. Obinutuzumab is glycoengineered type II humanized anti-cd20 monoclonal antibody. Glaxo approved in EU Tivicay for HIV and is preparing the launch to USA. In oncology has launched in USA trematinib for advanced melanoma and dabrafenib (BRAF inhibitor) for combination usage with trametinib (MEK inhibitor).both drugs attack gene mutation V600E or V600K trametinib and V600E dabrafenib respectively. GSK has received a positive opinion from CHMP of Europe for albiglutide a new GLP-1 agonist for diabetes treatment. In the field of COPD GSK has triumvirate and umeclidinium. ABBVIE is planning to replace Humira with a new treatment of Hepatitis C (a three-pronged Hepatitis C regimen). This 16

17 New Drugs Horizon åëëçíéêç regimen shows similar cure rates according to sustained viral response with Sofosbuvir of Gilead. The regimen consists of a fixed dose combination of ABT-450/Ritonavir four times/24h. In addition to proteace inhibition the regimen includes an NNSA inhibitor in ABT-267 and a non-nucleoside N55B inhibitor in ABT-333. Lilly is preparing to launch drugs for diabetes (three) and oncology (one). For type 2 diabetes develops the dulaglutide (GLP-1 analogue) a competitive agent with Bydu-reon (Astra-Zeneca) and Byetta (Novo) showing meantime superior efficacy compared with Lantus (Sanofi). Second molecule for type-2 diabetes is empagliflozin, a co-transporter-2 (SGLT2) a competitor to canagliflozin (Janssen) and dapagliflozin (Astra Zeneca). In oncology in phase III is ramucirumab, a drug for gastric cancer. Merck's plans included new entities in therapeutic areas like cancer, virology and cardiology. V503 is a second generation vaccine against the cancer-causing human papillomavirus. Comparing to Gardasil shows expanded coverage of HPV strains. In cardiology submitted data to EMA of vorapaxar is a development for treatment of atherothrombotic events of patients with heart attack history. In oncology two products are under development, the drug MK-3475 for melanoma and the vintafolide for ovarian cancer (cases resistant to platinum). Astrazeneca pipeline includes new molecules in phase III. Olaparib is an oncology drug for ovarian cancer for patients with BRCA mutation. Also approved Xigduo which is a combination of dapaglifozin with metformin in a twice a day regimen and is under development a once-daily tablet. Johnson & Johnson received approval in USA for Simeprevir for combination treatment of Hepatitis C. Another molecule is ibrutinib to treat mantle cell lymphoma. Another submission of ibrutinib is for treatment of relapsed chronic lymphocytic leukaemia. Among new files is a single tablet, once daily HIV combination of darunavir (Janssen's Prezista) with corbicistat. In diabetes (type-2) got approval from EU for canagliflozin. Another therapeutic area is tuberculosis with bedaquiline awaiting for approval for treatment of adults with multi-drug resistant TB. 17

18 åëëçíéêç Archeia Pharmakeftikis Pharmacoeconomics Section The importance of pharmacoeconomics for the health system Giannis Papadopoulos University of Athens, Faculty of Pharmacy, Department of Pharmaceutical Technology, Panepistimioupoli Zografou Corresponding author: Giannis Papadopoulos Ðåñßëçøç Ôï óýóôçìá õãåßáò äå ìðïñåß íá ïñéóôåß åýêïëá ãéáôß áðïôåëåßôáé áðü áñêåôïýò ðáñüãïíôåò ïé ïðïßïé öõóéêü ôï äéá ùñßæïõí êáé áðü ôï åîùôåñéêü ðåñéâüëëïí. Ùóôüóï, ï Professor Hsiao (Harvard University) ðñïóðüèçóå íá áðïäþóåé Ýíáí ïñéóìü ãéá ôï óýóôçìá õãåßáò ëýãïíôáò üôé ôï óýóôçìá õãåßáò åßíáé Ýíá äõíáìéêü êáé ðåñßðëïêï óýóôçìá. ¼óï áðëþò êáé áí áêïýãåôáé ï ïñéóìüò áõôüò, óôçí ïõóßá ðåñéãñüöåé ðëþñùò Ýíá óýóôçìá õãåßáò. Âáóéêïß óôü ïé ôïõ óõóôþìáôïò õãåßáò áðïôåëïýí ç äéáôþñçóç êáé âåëôßùóç ôçò õãåßáò ôùí ðïëéôþí, ç éêáíïðïßçóç ôïõò áðü ôéò ðáñå üìåíåò õðçñåóßåò êáé ç ïéêïíïìéêþ ôïõò ðñïóôáóßá. ÖõóéêÜ, ç åðßôåõîç áõôþí åðçñåüæåôáé áðü ôéò äïìýò ôïõ, ïé ïðïßåò åßíáé ç ñçìáôïäüôçóç, ç ðáñï Þ õðçñåóéþí, ç êáôáíïìþ ôùí ðüñùí êáé ç ïñãáíùôéêþ äïìþ. íá Üëëï áñáêôçñéóôéêü ôïõ óõóôþìáôïò õãåßáò åßíáé ï äõíáìéêüò ôïõ áñáêôþñáò. Áõôü ïöåßëåôáé óôï ãåãïíüò üôé åðçñåüæåôáé áðü ðïëëïýò åîùôåñéêïýò ðáñüãïíôåò üðùò åßíáé ç ãþñáíóç ôïõ ðëçèõóìïý, ç ïéêïíïìéêþ êñßóç, ç åìöüíéóç ôùí ñüíéùí ðáèþóåùí êáé ç åéóáãùãþ óôçí öáñìáêåõôéêþ áãïñü íýùí öáñìáêåõôéêþí ðñïúüíôùí. Ôá öüñìáêá áðïôåëïýí Ýíá óçìáíôéêü åñãáëåßï ãéá ôçí åðßôåõîç ôùí óôü ùí ôïõ óõóôþìáôïò õãåßáò óôá Ýñéá ôùí åðáããåëìáôéþí õãåßáò. Åêôüò áðü ôá óôïé åßá ðïõ áðïäåéêíýïõí ôçí áðïôåëåóìáôéêüôçôá ôùí öüñìáêùí, óçìáíôéêü åñãáëåßï ãéá ôçí ïñèþ ñþóç ôùí íýùí öáñìáêåõôéêþí ðñïúüíôùí áðïôåëïýí ôá óõìðåñüóìáôá ðïõ ðñïêýðôïõí áðü ôéò ìåëýôåò êüóôïõò-áðïôåëåóìáôéêüôçôáò ìéáò êáé óõìâüëïõí óôçí êáëýôåñç áîéïðïßçóç ôùí ðüñùí ôïõ óõóôþìáôïò êáé óôç ìåßùóç ôùí äáðáíþí õãåßáò. Ãéá áõôü åßíáé áðáñáßôçôï êáé áíáãêáßï ç ïñèþ ñþóç ôçò öáñìáêïïéêïíïìßáò, ç ïðïßá ïñßæåôáé ùò ç ðåñéãñáöþ êáé áíüëõóç ôïõ êüóôïõò ôçò öáñìáêåõôéêþò áãùãþò ãéá ôï óýóôçìá õãåßáò êáé ãéá ôç êïéíùíßá. Health system can not be easily defined due to the existence of many variables and boundaries which have been proposed to separate the health system form elements outside of them. However, a simple definition is based on its elements which are utilised as a policy instruments from the decision-makers. A health system consists of the resources, actors and institutions related to financing, regulation and provision of health actions that are any kind of activities whose primary intent is to improve or maintain health [Murray, 2000; WHO 2000a]. Although health improvement constitutes the defining goal of health system, there exist two other main objectives: consumer satisfaction and financial risk protection. The latter describes the fact that every one should fairly contribute to the costs of health system based on his ability to pay. Consumer satisfaction, on the other hand, shows that the system should perform in such way that the expectations of the population are satisfied [Murray, 2000; WHO 2000b]. Health System Goals Health Financial Risk Protection Consumer satisfaction Table 1: Health system goals 18

19 The importance of pharmacoeconomics for the health system åëëçíéêç The achievement of its aims is influenced by the level of accomplishment of intermediate objectives, which are: equity, effectiveness, efficiency and choice. It is, however, obvious that something else should exist so that the goals of the health system are attained. This is nothing but the four elements, financing, provision, organization arrangement and resource allocation, of the health system (Fig. 1). Especially, financing is related with the collection of revenues, the accumulation of funds and the allocation of budget to the providers. Provision refers to the services that are provided by health system and can be classified into personal when the services are utilized directly by the individuals or non-personal when the actions are applied collectively. Regarding while the organizational arrangement, it indicates the way with which the health system is organized and is regulated, while the fourth element is related with the way that the resources are allocated to the stakeholders [ Londono 1997; WHO 2000; Murray, 1995]. Figure 1: Health system elements and goals The previous diagram illustrates the complexity and interdependence between the elements and the targets. The main targets of health system can be achieved by altering the levers. However, manipulating an element does affect the others. Therefore, an interaction exists among the levers and a modification in one should be accompanied by changes in other elements in order to attain the main objectives of health system. An example constitutes that if reforms are limited to decentralizing services without changing the financing mechanisms, the incentives or the criteria for setting priorities, one is likely to simply multiply the problems of previously centralized system indicating any change should not only be focused on one element of health system [ Londono, 1997]. Another characteristic of the health system is its dynamic nature. Many factors within the health system lead it to change. However the health system is not in vacuum, but is influenced by environmental factors, such as the aging population, the economic crisis, the changes in pattern of diseases as and the increased availability of new treatments and technologies [Kanavos, 1998; Velliotis 2005]. One important external factor that influences the health system is the economic environment. th The improvement of health during the 20 century induces alterations of population demography. The mortality rates have decreased leading to increase in population growth rates. However, this rise has not occurred for a long period, because the fertility rates had diminished. This demographic transition causes a change in population distribution. Especially, people aged 65 and over compromise a growing proportion of population due to the increased life expectancy as well as the reduced mortality. The proportion of young people, on the other hand, has been diminished as a result of lower fertility rates.the demographic transition is associated with enormous epidemiological changes. The distribution of th causes of death has altered dramatically in the 20 century. In 1909, the major cause of death was infectious diseases, whereas today is chronic due to ageing population, along with non-communicable diseases. This alteration is known as the epidemiological transition. These changes have already increased the number of prescriptions dispensed by community pharmacists, while new expensive medicines 19

20 åëëçíéêç Archeia Pharmakeftikis have entered the market inducing the demographic transition. It is already known that an increase in older people is associated with an increase in the proportion of health users. Besides, older people are admitted to hospitals more often in comparison with younger patients and stay longer at hospitals. As a result, the health expenditures are raised and the percentage of GDP which is distributed to health should be enough to cover the costs. Moreover, the demographic transition affects the funding mechanism of the health system, because the percentage of working population is decreased resulting in the reduction of the contribution to the health care funds. The funding mechanism is also affected by the unemployment rate, which is very high now due to the economic crisis. In addition, the introduction of new, expensive, more efficient medicines together with the great demands of the users for effective treatment, influence the economic situation of the health system. Moreover,the elderly population suffer from multiple disorders and as a result, the pharmaceutical expenditures are augmented. Effective drug therapy helps to partially explain why the mean length of stay in hospitals has decreased over the years. Thus, the financing of health system should be altered appropriately in order to meet the new demands [WHO, 2004b; WHO, 2004c; Kanavos, 1998]. It is therefore obvious that the medication constitute an important parameter in order for the health care system to achieve its goals. Despite the general evidence supporting the use of pharmaceuticals, few data exist regarding the actual costs and benefits attributed to specific drug therapies. Nowadays, the health expenditures have raised rapidly and the aim of the stakeholder is to decrease them following a cost-containment health policy.however, successful healthcare management as measured by the objectives of patients, physicians and other healthcare providers as well as by societal expectations, requires that the quality of care also be maintained. This means that the important issue concerns the optimum manner of investing health care resources to generate health gain without altering the quality of health care. In order for the stakeholder to achieve this policy, it is necessary to utilize properly a tool named as pharmacoeconomics. It constitutes a branch of health economics which particularly focuses upon the costs and the benefits of medicines and it has been defined as the description and analysis of the costs of drug therapy to health care systems and society. It identifies, measures and compares the costs and consequences of the medicines and the services. During the early 1960, pharmacy began evolving as clinical discipline within the healthcare system. It was during this time that the pharmaceutical science disciplines such as pharmaceutics, clinical pharmacy, drug information and pharmacokinetics became a critical and integral part of pharmacy education and science. In the 1970s, pharmacoeconomics developed its roots. In 1978, McGhan, Rowlan dnd Bootman from the University of Minnesota introduced the concepts of cost-benefit and cost - effectiveness analyses. However,the actual term pharmacoeconomics did not appear in the literature until 1986 when the first of a two part presentation by Townsend was published describing the need to develop research activities in the evolving discipline. It is therefore easily understood that this new tool is very crucial, because it could help the policy makers to take decisions for the pharmaceutical therapy within the health system based on the evidence from pharmacoeconomics at- taining the goals of the health system utilising appropriately its resources. References: Murray Christopher & Frenk Julio (2000); A framework for assessing the performance of health system ; Bulleting of the World Health Organization; Volume 78, Issue 6; pages 20

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