Investor & Analyst Presentation: Lundbeck (Lundbeck) - Sep 1, 2012 - Anticipated submission of MAA in Europe is on track and expected around Q4 2012 and anticipated approval US/EU is expected in 2013 for Aripiprazole depot; Anticipated NDA submission for OPC-34712 is expected in 2014; Anticipated submission of MAA and approval of OPC-34712 in US is expected in 2015; Expected enrollment for zicronapine is 160 patients; Lundbeck launched Sycrest in Japan for schizophrenia
Anticipated EU regulatory • Anticipated FDA event • Enrollment status • Launch non-US • Schizophrenia
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Strong financial engine
Continued launch of Onfi, Sycrest and Lexapro (Japan)
Submissions and expected approvals
2012
Aripiprazole depot (EU) : Submission
2013
Aripiprazole depot (US*/EU) : Approval
2014
OPC-34712 (US) : Submission
2015
OPC-34712 (EU) : Submission
OPC-34712 (US) : Approval
Aripiprazole depot - a treatment aimed at improving compliance
Europe
Submission of MAA in Europe is on track and expected around year-end 2012
Expected main events next 12 months
Submission of MAA for aripiprazole depot (EU) (around year-end)
Clinical phase III programme commenced with zicronapine in schizophrenia
The clinical phase III study
Expected to enroll 160 patient
Patients will receive zicronapine (7.5mg/day ) or risperidone (5mg/day) in a 1:1 ratio
Further phase III studies will be initiated in due time...
(IR6)
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