Corporate Magazine 2012 - Boehringer Ingelheim

With regard to the test substance nintedanib, severalphase III studies are currently being conducted, examiningthe efficacy of the substance for treating patientswith advanced non-small-cell bronchial carcinoma orfor treating female patients with ovarian cancer. The resultsof these extensive studies are expected in 2013.Boehringer Ingelheim’s development activities in thetherapeutic area of infectious diseases are focused onviral diseases with high, previously unmet medical needs.The focus here is on treatment of hepatitis c viruses(HCV). The portfolio comprises the enhancement of inhibitorsthat attack key viral enzymes, such as HCV serineprotease and RNA polymerase. Here, we are examiningthe two direct-action antiviral substances (DAA)faldaprevir (BI 201335) and BI 207127. The first is ahighly effective, orally administered HCV-NS3/4A proteaseinhibitor and is being examined in several multinational,randomised, double-blind and placebo-controlledphase II studies (SILEN-C® study programme). Theefficacy and safety of faldaprevir combined with pegylatedinterferon and ribavirin (PegIFN/RBV) in patients infectedwith HCV genotype 1 are being examined here. Inthe above-mentioned studies, faldaprevir shows an improvedsustained viral response (SVR), a measure ofhealing in viral diseases. The product was generally verywell tolerated and showed a beneficial safety profile, i.e.low incidence of skin rash and no anaemia or hepatictoxicity.Test substance BI 207127 is an NS5B-RNA-dependentpolymerase inhibitor with the potential, when used incombination with faldaprevir and ribavirin, to eliminatethe need for interferon for HCV treatment. BI 207127blocks a specific step in the viral life cycle by attacking ahighly preserved part of this polymerase enzyme, thussuppressing HCV replication. The HCVerso phase IIIstudies that are examining this dosage scheme were initiatedin the 2012 financial year. To provide HCV patientswith new medications in good time, the US Food andDrug Administration (FDA) has promised to accelerateprocessing of the interferon-based development programmesfor faldaprevir in combination with PegIFN/RBV and treatment without interferon with faldaprevirand BI 207127 plus ribavirin.Animal HealthThe main focal points of research at Boehringer Ingelheim’sAnimal Health business are the research and developmentof innovative vaccines, primarily to protectfood-producing animals and pets, and pharmaceuticalproducts. In the last financial year, the company investedaround EUR 115 million in research and development ofnew products and in setting up new R&D sites. This representsapproximately 11% of the overall sales generatedby our Animal Health business.New active ingredients are researched and future-orienttatedtherapeutic solutions are developed at our sites inthe USA, Germany, Mexico, China and Japan. As manyvaccines are based on local pathogens or pathogen variants,it is necessary to be represented with in-house research,development and production facilities in all keysales regions. The 2012 financial year saw the opening ofthe European Research Centre for Animal Vaccines inHanover, Boehringer Ingelheim’s fourth German site.We invested more than EUR 40 million in the BoehringerIngelheim Veterinary Research Centre (BIVRC). 55 employeesare already working on developing innovativevaccines for livestock. By 2017, up to 102 highly qualifiedscientists, laboratory workers and animal keepers areexpected to work at the BIVRC. Our first Asian researchand development centre for veterinary medicine has beenbuilt in China. Boehringer Ingelheim is investing a totalof EUR 12 million in the centre at the Zhangjiang High-Tech Park in Shanghai, which opened in 2012. These investmentfigures clearly illustrate our commitment andlong-term aim of expanding the company worldwide inthe area of animal health.In the 2012 financial year, Boehringer Ingelheim obtainedEuropean market approval for administration of theporcine vaccines ingelvac circoflex® and ingelvacmycoflex® using the FLEXcombo® method. This makesit possible to vaccinate pigs simultaneously against porcinecircovirus (PCV) type 2 and Mycoplasma hyopneu-26Boehringer Ingelheim annual report 2012