Results of ADAGIO study with Azilect® in Parkinson's disease
published in The New England Journal of
(Thomson Reuters ONE) - One of the largest Parkinson's disease studies demonstrates benefitof early treatment with Azilect® 1 mg/dayH. Lundbeck A/S' (Lundbeck) partner Teva Phamaceuticals IndustriesLtd. (Teva) today announced that results from the ADAGIO trial,published online today in The New England Journal of Medicine,demonstrated that Parkinson's disease patients receiving Azilect®(rasagiline) 1mg/day at the start of the study (early-start group)experienced superior benefit over 18 months compared with those whostarted the exact same treatment nine months later (delayed-startgroup)1. This finding is consistent with a possible disease-modifyingeffect for Azilect® 1 mg/day.Professor C. Warren Olanow, MD, Department of Neurology, Mount SinaiSchool of Medicine, New York and co-principal investigator of theADAGIO study, commented, "A therapy that slows or stops diseaseprogression is the greatest unmet need in the treatment of patientswith Parkinson's disease. Current therapies do not prevent thedevelopment of disability in such patients. The results of the ADAGIOstudy provide support for the possibility that early treatment withAzilect® 1 mg/day may slow the development of disability."Azilect® is the first Parkinson's disease treatment to succeed in aprospective delayed-start study, a trial design specificallydeveloped to test for the possibility of a disease-modifying effect.Professor Olivier Rascol, Department of Clinical Pharmacology,University Hospital, Toulouse, France and ADAGIO co-principalinvestigator, stated, "The results of the ADAGIO study provide noveldata to support the use of Azilect® 1 mg daily as initial treatmentof patients with Parkinson's disease. The ADAGIO study, whichutilized a novel trial design with three primary endpoints, suggeststhat the drug has a positive impact on slowing the progression ofpatients' disability, beyond its already known symptomatic benefit."The content of this release will have no influence on the LundbeckGroup's financial result for 2009.About ADAGIOADAGIO (Attenuation of Disease progression with Azilect® GivenOnce-daily) was a randomized, multi-center, double-blind,placebo-controlled, parallel-group study prospectively examiningrasagiline's potential disease-modifying effects in 1,176 patientswith early, untreated Parkinson's disease. Patients from 129 centersin 14 countries participated and were randomized to initiatetreatment for 72 weeks with rasagiline 1 mg/day or 2 mg/day, or toinitiate treatment for 36 weeks with a placebo followed by 36 weekswith rasagiline 1 mg/day or 2 mg/day.The primary analysis included three hierarchical endpoints based ontotal scores in the Unified Parkinson's Disease Rating Scale (UPDRS).Azilect® 1 mg/day early-start met all endpoints of the primaryanalysis: less deterioration in UPDRS score than placebo betweenweeks 12 and 36; less worsening than delayed-start in UPDRS score incomparing change between baseline and week 72 despite being on thesame medication for the last 9 months; and non-inferiority todelayed-start in rate of deterioration between weeks 48 and 72. TheADAGIO study also confirmed the positive symptomatic effect andsafety profile of Azilect®, in line with prior studies2.About Azilect®Azilect® (rasagiline) 1 mg tablets are indicated for the treatment ofthe signs and symptoms of Parkinson's disease both as initial therapyalone and to be added to levodopa later in the disease. Azilect® 1 mgtablets are now available in 38 countries, including the U.S.,Canada, Israel, Mexico and all of the European Union countries, whereit is marketed by Teva in collaboration with Lundbeck as part of along-term strategic alliance.About Parkinson's diseaseParkinson's disease is an age-related degenerative disorder of thebrain. Symptoms can include tremor, stiffness, slowness of movementand impaired balance. An estimated four million people worldwidesuffer from the disease, which usually affects people over the age of60.References1. Olanow CW et al. A double-blind delayed start trial ofrasagiline in Parkinson's disease. NEJM 20092. Parkinson Study Group. A controlled trial of rasagiline inearly Parkinson's disease. Arch Neurol 2002;59:1937-1943Lundbeck contactsInvestors: Media:Jacob Tolstrup Mads KronborgDirector, IR & Communication Media Relations+45 36 43 30 79 +45 36 43 28 51Palle Holm Olesen Kasper RiisHead of Investor Relations Media Relations+45 36 43 24 26 +45 36 43 28 33Magnus Thorstholm JensenInvestor Relations Officer+45 36 43 38 16About LundbeckH. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an internationalpharmaceutical company highly committed to improve the quality oflife for people suffering from central nervous system (CNS)disorders. For this purpose Lundbeck is engaged in the research anddevelopment, production, marketing and sale of pharmaceuticals acrossthe world, targeted at disorders like depression and anxiety,schizophrenia, insomnia, Huntington's, Alzheimer's and Parkinson'sdiseases.Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark,and employs today over 5,500 people worldwide. Lundbeck is one of theworld's leading pharmaceutical companies working with CNS disorders.In 2008, the company's revenue was DKK 11.3 billion (approximatelyEUR 1.5 billion or USD 2.2 billion). For more information, pleasevisit www.lundbeck.com.http://hugin.info/130085/R/1343255/321727.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 23.09.2009 - 23:02 Uhr
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