Sustainability Report 2010 Janssen Pharmaceutica NV Foreword The pharmaceutical sector in 2010 was again con- The above information is also clearly reflected in our fronted with very significant cuts in the budgets set annual figures. The turnover increased by 196 million aside for medication, both at home and abroad. euro compared to 2009, while the other operating TThese cuts were mainly a consequence of the eco- income increased by 95 million euro in 2010. Profit nomic crisis and the credit problems in a number of amounted to 22 million euro, which is 26 million euro countries during 2008 and 2009, and they also have more than in 2009. The investment figures for both an impact on Janssen. The price reductions imposed the campus in Beerse and the campus in Geel de- in the past years, and the taxation on prescription monstrate that we still firmly believe in Belgium as medicine turnover continue to negatively impact our our place of business. In 2010, we spent more than 1 profitability. billion euro on Research & Development, in addition to substantial sums on infrastructure and new tech- Despite the loss in income due to the expiry of major nologies. In Beerse, for example, major investments patents in recent years, Janssen has continued to were made in a production line for the production of invest in Research & Development, and this has McNeil products and in the necessary adjustments to resulted in even more pressure on the company’s the building in order to prepare it for the move of our profitability. The pharmaceutical industry is currently sister company Tibotec-Virco’s employees from characterized by a decline in the efficiency and pro- Mechelen to Beerse. The major investment project in ductivity of efforts with regard to Research & Geel was the further completion of the new Pilot Development. Janssen has not escaped from this Plant and the associated utilities. general trend. In order to address this negative evo- lution, Janssen has created the Office for Campus In addition, industrial land was purchased in La Strategy & Growth (OCS) in 2010. This team has Louvière with the aim of building a European already taken a number of initiatives in the context of Distribution Center for the J&J Pharmaceuticals Open Innovation in the meantime. For example, the Group, which is currently under construction. In active search for different forms of cooperation with Diegem, an office building was purchased and reno- interesting third parties, and offering some of these vated and will be made available to the Belgian com- parties the possibility of establishing themselves on panies of the J&J MD&D Group; the MD&D Group will our company site. move here in the course of 2011. In the context of the reduction of the number of Johnson & Johnson the acquisition of the operating sites on a global scale, our colleagues from Dutch company Crucell by Janssen-Cilag Benelux, GCO and J&J Consumer J&J, an operation that was moved from Berchem to Beerse 2 last year. The high successfully completed concentration of know-how in a limited number of early in 2011, is probably locations in Belgium is already important in itself. But even more important, and the major benefit is that, from now on, all these that offers us the perspec- departments and services will work even closer tive of developing into one together in order to obtain a whole that is greater of the world players in the than the sum of its components. This should give us area of vaccines in time. the assurance that we are in a strong position to face the future. Taking the difficult economic conditions and numer- ous challenges of the markets into account, we are We can also report plenty of positive news in the area now focusing more than ever on our main objective: of the development of new medicines in 2010. For To develop new drugs against complex diseases for example, a total of no less than four registration which insufficient effective treatment is currently applications were submitted in the USA and/or available. Janssen in Belgium is playing a leading role Europe. These are also important files, including the in this respect, and remains a major player in the INCIVO (telaprevir) file, a pioneering product for social and economic areas, as well as a world player in patients suffering from hepatitis C, and the ZYTIGA drug research, development and production. But all (abiraterone) file, a promising product for patients this is only possible thanks to the motivation and with prostate cancer that has been approved by the efforts of our employees in all the areas in which we American FDA in the meantime. With these medi- operate. Their talents continue to be our greatest cines, we are setting a new standard in the treatment assets for our continued success in the future. of these diseases. There is also fresh hope for HIV/ AIDS patients, because we have a very promising new medicine in the pipeline for them as well, EDURANT (rilpivirine), a product that was discovered on our campus. The management is confident that these important products will soon meet the needs of a great many patients, and will be able to help fill some of the still numerous gaps in the health care sector. In addition, major cooperation agreements were signed with a significant number of academic institu- tions and external companies. We mention here, for example, the cooperation with the renowned Koch Tom Heyman Institute in the USA, which holds great promises for Managing Director future innovations in the battle against cancer. But Janssen Pharmaceutica NV D2011/1060/04 JANSSEN PHARMACEUTICA - SUSTAINABILITY REPORT 2010 1 Patients Janssen Pharmaceutica’s most important The global integration of Johnson & Johnson’s contribution to society is the discovery, pharmaceutical research activities also pro- development and production of new drugs. vides other departments based in Beerse JExpenditure on Research & Development with plenty of opportunities for intensive increased slightly in 2010, and amounted to cooperation and support. The possible 1,067 million euro. The basis of our R&D establishment of external partner compa- activities remains the search for new medi- nies at the campus will also have an enrich- cines with a high added-value that are not ing impact on our own R&D staff. In addition only safe and efficient, but also satisfy unmet to the close cooperation with academic cen- medical needs. This means that we focus pri- ters, biotech companies and other pharma- marily on those disease areas for which no ceutical partner companies, a number of effective treatments are available yet. agreements were entered into in 2010 that are particularly important for our future. The Janssen R&D departments in Beerse These include agreements with WuXi mainly focus on the research into substances PharmaTech, which operates in China and intended for disorders in the field of neuro- the USA in the area of pre-clinical services, sciences (psychiatry and degenerative disor- the Koch Institute in the USA, which is con- ders), oncology (remedies for slowing down centrating on cancer research, and Neuro- the growth of tumors) and infectious diseas- Search, a Danish company active in the field es, areas in which we currently hold a leading of neurological research. In our own coun- position worldwide, or in which we intend to try, a collaboration with the Flemish Institute become market leaders in the future. for Biotechnology was announced, with the Diagnostic tools will also become an impor- aim of developing new medicines for the tant research area for us. Our colleagues treatment of psychiatric and neurodege- from Tibotec-Virco Virology, who have been nerative disorders. based on the campus in Beerse since mid- 2010, are concentrating on the discovery In 2010, several files of important new pro- and development of pharmaceutical products ducts were submitted to the authorities for an and innovative treatment methods that can initial or for additional registration. In addi- be useful in the treatment of patients with tion, our company was involved in the devel- chronic infectious diseases, such as HIV/ opment and/or production of a number of AIDS, hepatitis C and tuberculosis. substances by their group associations. 2 JANSSEN PHARMACEUTICA - SUSTAINABILITY REPORT 2010 Products for which the registration application was submitted in 2010: XEPLION® (paliperidone palmitate) schizophrenia 1250 INCIVO® (telaprevir) hepatitis C ZYTIGA® (abiraterone acetate) prostate cancer 1000 1,137 EDURANT® (rilpivirine) HIV/aids 1,106 1,067 1,031 XARELTO® (rivaroxaban) venous thrombosis and atrial fibrillation 750 REMICADE® (infliximab) pediatric ulcerative colitis INVEGA® (paliperidone) pediatric schizophrenia 500 YONDELIS® (trabectedine) ovarian cancer 250 NUCYNTA ER® (tapentadol) chronic pain SIMPONI® (golimumab) rheumatoid arthritis 0 Progress was booked in the research into the following substances: 2007 2008 2009 2010 Bapineuzumab IV Alzheimer’s disease Canagliflozin type 2 diabetes Evolution of R&D investments (in million euros) CNTO136 (sirukumab) autoimmune diseases DACOGEN™ (decitabine) cancer treatment Fulranumab pain relief CNTO328 (siltuximab) cancer treatment TMC207 tuberculosis TMC435 (simeprevir) hepatitis C In the calendar year 2010, 42 new patent applications were submitted under the name Indicators 2007 2008 2009 2010 of Janssen Pharmaceutica NV. Numerous R&D investments (in million euros) 1,137 1,106 1,031 1,067 checks to ensure patient well-being and Product responsibility: safety are carried out in both the initial stages system available Yes Yes Yes Yes of research and during the development, production and sale of our medicines. The company keeps the various authorities Subject Programs Audit up-to-date on progress and applies for the Product responsibility Quality Assurance, GLP, GMP Internal and external, necessary licenses that are required by law. Internal reporting international For example, a new environmental permit Regulatory files was obtained for the expansion of our sites Pharmacovigilance with the activities of Tibotec-Virco, Janssen- Cilag Benelux and J&J Consumer.