Corporate Magazine 2012 - Boehringer Ingelheim

esearch & developmentperspectives for medical innovationAFATINIB – SYNTHESIS OF ACTIVE PHARMACEUTICAL INGREDIENTDue to the high number of large-scaleinternational clinical studies with morethan 3,500 patients, supplying afatinibfilm-coated tablets, various referencepreparations and co-medications was alogistical challenge for the global ClinicalTrial Supplies Unit (CTSU) and themanufacturing units.To safeguard the extensive clinical programmeand to ensure market supplypost-approval, a standalone oncologicalproduction facility was set up in Ingelheim.This was established in order tomeet the special safety requirementsfor afatinib. At this dedicated facility,all necessary manufacturing steps forafatinib can be covered, from theinitial weighing of the substancethrough dry granulation and tablettingto tablet film-coating and packaging.1 Synthesis of active pharma ceuticalingredients for afatinib in Ingelheim.1the safety and efficacy of afatinib plusvinorelbine compared with trastuzumabplus vinorelbine in patients withmetastatic HER-2 positive breast cancerwho received prior treatment withtrastuzumab.VolasertibVolasertib is an investigational inhibitorof polo-like kinase (Plk), an enzymethat regulates cell division (mitosis).This inhibition is intended toresult in prolonged cell cycle arrestand ultimately cell death (apoptosis).Acute myeloid leukaemia (AML)AML is one of the most common typesof leukaemia in adults, accounting for25% of all adult leukaemias in thewestern world. AML has one of thelowest survival rates of all leukemias.The most common treatment approachis intensive remission inductiontherapy. However, many patientsover 65 years of age are ineligible forthis approach, which involves largedoses of chemotherapy over a periodof five to seven days.Clinical trial results in AMLPositive phase II results from an interimanalysis of the randomisedphase I/II study involving volasertibin newly diagnosed patients withacute myeloid leukemia (AML) consideredineligible for intensive remissioninduction therapy were published.In this study, higher rates ofobjective response and an improvementin event-free survival were observedin patients treated with volasertibin combination with low-dosecytarabine (LDAC) compared withpatients treated with LDAC alone.Based on these positive results, aphase III study, POLO-AML-2, withvolasertib in combination with LDACwas initiated.LIFE WITH LUNG CANCERPATIENT PORTALThe portal is a comprehensive onlineresource for individuals coping with adiagnosis of lung cancer, and for familyand friends providing support andcare for their loved ones. It focuses onengaging and empowering patientssuffering from cancer and puts theindividual’s own journey at the heartof its navigation.www.lifewithlungcancer.infoFor more information go to:www.thewhiteroom.infowww.youtube/oncologyPioneering treatments for cancer51