Corporate Magazine 2012 - Boehringer Ingelheim

our businessesperspectives for better healthPRADAXA®-DEVELOPMENT AT BOEHRINGER INGELHEIMLead molecule in the directoral thrombin inhibitorproject works in vivo.Dabigatranetexilate isselected fordevelopment.Phase II studiesin about 2,300patients.First patientsare enrolledin RE-LY®.European approval for dabigatranfor the preventionof VTE after hip or kneereplacement surgery.Research on a directoral thrombin inhibitorbegins.The dabigatranmolecule isdiscovered.First batch ofdabigatransuccessfullysynthesised.Innovativecapsuledeveloped.RE-VOLUTION®clinical trialprogrammestarted.FDA approvespradaxa® for strokerisk prevention inpatients with AF.pradaxa® approvedin the EUfor stroke preventionin AF.1992 1996 1997 2002 2004 2005 2008 20102011Sustained, long-term protectionData from the RELY-ABLE® study presentedin 2012 supports the long-termsafety profile and efficacy of pradaxa®.Highly consistent with the findingsfrom the landmark RE-LY® trial, the resultsobserved during the additionalfollow-up demonstrate the sustainedprotection over a treatment duration ofmore than four years and support thebenefit of both doses for tailored patienttreatment.Safety confirmedIn 2012, the positive risk-benefit profileof pradaxa® has been confirmed by independentregulatory appraisals of realworlddata led by the US Food and DrugAdministration (FDA) as well as the EuropeanMedicines Agency (EMA), whichhighlight that the drug offers importantbenefits to patients.Further researchBoehringer Ingelheim remains dedicatedto advancing science and ensuring thatphysicians have all the tools they mayrequire to effectively manage patients, includingin critical situations. BoehringerIngelheim is therefore currently developinga specific antidote to the anticoagulationeffect of pradaxa® to add tothe existing reversal strategies alreadyavailable in clinical practice.Unprecedented insightsWe continue to collaborate with regulatoryauthorities worldwide. In Germany,we have taken the unprecedented stepof actively and regularly sharing safetydata with physicians – achieving a newlevel of transparency and openness.Furthermore, unique insights have beenprovided through the development of‘Finding the right molecule’, a bookguiding readers through the innovativedevelopment journey of pradaxa®.Challenges of reimbursementpradaxa® addresses the demands foran effective treatment option, providingsustained and reliable stroke prevention.At the same time, health care systemsworldwide face increasing costrestrictions, providing a challengingenvironment for reimbursement. Still,PRADAXA®, PRADAXAR®,PRAZAXA®is a novel reversible oral directthrombin inhibitor that blocks theactivity of thrombin, the centralenzyme in clot formation. It isapproved for the primary preventionof venous thrombo-embolism(VTE) in adults who have undergoneelective total hip or kneereplacement surgery and was thefirst new anticoagulation therapyin over 50 years to be approvedfor the prevention of stroke andsystemic embolism for adultpatients with non-valvular atrialfibrillation who are at risk ofstroke.Reducing stroke risk in atrial fibrillation71