Source: Biotie Therapies May 04, 2012 02:00 ET Biotie Interim report 1 January - 31 March 2012 BIOTIETHERAPIESCORP.StockExchangeRelease4May,2012at 9.00a.m. BiotieInterimreport1January-31March2012 BiotiereportsQ12012results;clinicaldevelopmentremainsontrack,with importantinflectionpointsexpectedinH22012andbeyond CompanyHighlights *SuccessfullycompletedaclinicalPETimagingstudywithSYN120 *PartnerLundbeckpresenteddataatthe2012EuropeanCongressofPsychiatry showingthatSelincroreducestotalalcoholconsumptionbytwo-thirdson averageaftersixmonthsoftreatment,furtherdatatobepresentedata medicalconferenceinthesummer *PanuMiettinenappointedChiefFinancialOfficer(CFO)andamemberofthe Group'smanagementteam,effectiveMarch15,2012 KeyFinancialsfortheperiodendingMarch31,2012 Figuresinbrackets,unlessotherwisestated,refertothesameperiodinthe previousyear(EURmillion) *RevenuesEUR0.0million(0.5) *ResearchanddevelopmentcostsEUR5.8million(4.9) *FinancialResult(Netloss)EUR-7.5million(-7.7) *Cashflowfromoperatingactivities,continuingoperationsEUR-9.3million (-4.2) *LiquidassetsattheendofperiodEUR24.7million(46.8) *Earningspershare-0.02(-0.03) Theinterimreportisunaudited.Liquidassetsarecomprisedofcash,cash equivalentsandinvestmentsheldtomaturity. TimoVeromaa,Biotie'sPresidentandCEOcommented,"Weareverypleasedwith theprogressofourclinicalstudies.Withourleadasset,Selincro,under reviewattheEuropeanMedicinesAgencywithourpartnerLundbeck,ourfocusis ondrivingforwardthenextwaveofproductsinourpipeline,forwhichwecould seeanumberofimportantdatapointsinthenext12-18months". Outlookfor2012andkeyupcomingmilestonesin2012 Selincro(nalmefene):Amarketingauthorizationapplication(MAA)forSelincro foralcoholdependence,submittedbyBiotie'spartnerLundbeck,wasacceptedfor reviewbytheEuropeanMedicinesAgency(EMA)inDecember2011.Pending approval,thenextmilestonepaymentstoBiotieareexpectedoncommercial launchofSelincroandontheproductreachingcertainpredeterminedsales. Tozadenant(SYN115):APhase2bstudyinParkinson'sdisease,fundedbyBiotie, isongoingwithtop-linedataexpectedH12013. SYN120:RochehasanoptiontolicenseSYN120fordevelopmentand commercializationfollowingthecompletionoftheclinicalPETimagingstudy. Nepicastat(SYN117):Phase2studyongoing,fundedbytheUSDepartmentof Defense,forthetreatmentofpost-traumaticstressdisorder(PTSD);top-line dataareexpectedinH22012. UndertheagreementwiththeNationalInstituteonDrugAbuse(NIDA)attheUS NationalInstitutesofHealth,NIDAandBiotiearejointlyinvestigatingthe safetyandefficacyofnepicastatinthetreatmentofcocainedependence.The trialisexpectedtostartinH22012. BTT-1023(VAP-1antibody):Biotieiscurrentlyoptimizingthescale-upofthe manufacturingprocessforBTT-1023andexpectstostartproof-of-concept clinicalstudiesinselectedindicationsinH22012. Ronomilast:Biotieisseekingapartnerforfurtherdevelopmentand commercializationofthisproduct. Disclosureprocedure BiotieTherapiesCorp.hasstartedtofollowthedisclosureprocedureenabledby Standard5.2bpublishedbytheFinnishFinancialSupervisionAuthorityand herebypublishesitsInterimReportforJanuary-March2012attachedtothis stockexchangereleaseinpdfformat.TheInterimReportisalsoavailableon thecompany'swebsiteatwww.biotie.com. Conferencecall Ananalystandmediaconferencecallwilltakeplaceon4May2012at10:00a.m. CentralEuropeanTime.TheconferencecallwillbeheldinEnglish. Linesaretobereservedtenminutesbeforethestartofconferencecall.The eventcanalsobeviewedasalivewebcastatwww.biotie.com.Anondemand versionoftheconferencewillbepublishedonBiotie'swebsitelaterduringthe day Telephoneconferencenumbers: UScallers:+16462543360 UKcallers:+44(0)2071362051 Finnishcallers:+358(0)923101621 Accesscode:1547005 Incaseyouneedadditionalinformationorassistance,pleasecontact:Virve Nurmi,IRManager,Tel:+35822748911 Keyeventsafterthereportingperiod Biotieannouncedon24April2012thatithasagreedwithitspartnerSeikagaku CorporationtoterminatewithimmediateeffecttheirLicenseAgreementon Biotie'sVAP-1antibodyprogram,BTT-1023.Thelicense,underwhichBiotiehad grantedSeikagakuexclusiverightsfordevelopmentandcommercializationofBTT- 1023inJapan,Taiwan,Singapore,NewZealandandAustralia,wasexecutedin April2003andwasbuiltaroundSeikagaku'sexpertiseinlocomotivediseases. Biotiehasre-profiledBTT-1023tofocusonfibroticdiseases,andthisisnota focusinSeikagaku'sdevelopmentstrategy.Thelicenseagreementalsoincluded anoptionforBiotie'sVAP-1SSAOsmallmoleculeinhibitors. Biotieannouncedon2May2012thatDr.JamesS.Shannonhasnotifiedthe companythathewillresignfromtheBoardofDirectorsofBiotie,effective immediately.Dr.ShannonhasbeenappointedCorporateChiefMedicalOfficerwith GlaxoSmithKlineinLondonasofMay1st2012andwillresignfromallexternal Boardpositions. Asaconsequence,theBoardofDirectorsinitsmeetingof3May2012appointed GuidoMagniasamemberoftheAuditCommittee.Thecompositionofthecommittee afterthenominationisBerndKastlerasChairmanandMerjaKarhapääandGuido Magniasmembers. AboutBiotie Biotieisaspecializeddrugdevelopmentcompanyfocusedonthedevelopmentof drugsforneurodegenerativeandpsychiatricdisorders(e.g.Parkinson'sdisease, Alzheimer'sdiseaseandothercognitivedisorders,alcoholanddrugdependence (addiction)andposttraumaticstressdisorder),andinflammatoryandfibrotic liverdisease.Thecompanyhasastrongandbalanceddevelopmentportfoliowith severalinnovativesmallmoleculeandbiologicaldrugcandidatesatdifferent stagesofclinicaldevelopment.Biotie'sproductsaddressdiseaseswithhigh unmetmedicalneedandsignificantmarketpotential. Partnershipswithtop-tierpharmaceuticalpartnersareinplaceforseveral programsaswellasastrategiccollaborationwithUCBPharmaS.A.TheMarketing AuthorizationApplicationforBiotie'smostadvancedproduct,SelincroTM (nalmefene)foralcoholdependencewasfiledintheEUbyourpartnerH. LundbeckA/SandwasacceptedforreviewbytheEuropeanMedicinesAgencyin December2011. Turku,4May2012 BiotieTherapiesCorp. BoardofDirectors Forfurtherinformation,pleasecontact: VirveNurmi,InvestorRelationsManager tel.+35822748900 e-mail:[email protected] Distribution: NASDAQOMXHelsinkiLtd Mainmedia www.biotie.com Attachment: Biotie_Q12012Interimreport [HUG#1608761] Attachments: Biotie_interim report Q1 2012.pdf.
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