(19) &  

(11) EP 1 541 197 B8

(12) CORRECTED EUROPEAN PATENT SPECIFICATION

(15) Correction information: (51) Int Cl.: Corrected version no 1 (W1 B1) A61K 31/343 (2006.01) A61K 31/4545 (2006.01) Corrections, see A61P 25/22 (2006.01) A61P 25/24 (2006.01) Bibliography INID code(s) 56

(48) Corrigendum issued on: 10.06.2009 Bulletin 2009/24

(45) Date of publication and mention of the grant of the patent: 18.03.2009 Bulletin 2009/12

(21) Application number: 04025035.9

(22) Date of filing: 21.10.2004

(54) Use of pipamperone and an SNDRI, SNRI or SSRI for the treatment of mood or anxiety disorders Verwendung von Pipamperon und einem SNDRI, SNRI oder SSRI zur Behandlung von Stimmungs- oder Angststörungen Utilisation de pipamperone et d’un SNDRI, SNRI ou SSRI pour le traitement des troubles de l’humeur ou anxieux

(84) Designated Contracting States: • VOLMAT R ET AL: "The treatment of depressions AT BE BG CH CY CZ DE DK EE ES FI FR GB GR by Cledial. Evolution and clinical state and HU IE IT LI LU MC NL PL PT RO SE SI SK TR handwriting" PSYCHOLOGIE MEDICALE 1986 FRANCE, vol. 18, no. 10, 1986, pages 1615-1622, (30) Priority: 02.12.2003 EP 03447279 XP009028776 05.01.2004 EP 04447001 • SQUELART P ET AL: "Pipamperone (Dipiperon), 18.03.2004 EP 04447066 a useful sedative neuroleptic drug in troublesome chronic psychotic patients." ACTA (43) Date of publication of application: PSYCHIATRICA BELGICA. BELGIUM 1977 MAR- 15.06.2005 Bulletin 2005/24 APR, vol. 77, no. 2, March 1977 (1977-03), pages 284-293, XP009028314 ISSN: 0300-8967 (73) Proprietor: PharmaNeuroBoost N.V. • KOCH H J ET AL: "Successful therapy of tardive 3570 Alken (BE) dyskinesia in a 71-year-old woman with a combination of tetrabenazine, olanzapine and (72) Inventor: Buntinx, Erik tiapride." INTERNATIONAL JOURNAL OF 3750 Alken (BE) CLINICAL PRACTICE. ENGLAND MAR 2003, vol. 57, no. 2, March 2003 (2003-03), pages 147-149, (74) Representative: De Clercq, Ann G. Y. et al XP009030046 ISSN: 1368-5031 De Clercq, Brants & Partners c.v. • DIEBOLD K. ET AL: "Are psychoactive-drug- Edgard Gevaertdreef 10a induced changes in plasma lipid and lipoprotein 9830 Sint-Martens-Latem (BE) levels of significance for clinical remission in psychiatric disorders?." (56) References cited: PHARMACOPSYCHIATRY, (1998) 31/2 (60-67)., WO-A-98/43646 DE-A- 4 039 631 1998, XP009029360 US-A- 5 762 960

Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 1 541 197 B8

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• PERUGI G ET AL: "EFFECTIVENESS OF • ENGELBORGHS S ET AL: "AMINO ACIDS AND ADJUNCTIVE GABAPENTIN IN RESISTANT BIOGENIC AMINES IN CEREBROSPINAL FLUID BIPOLAR DISORDER: IS IT DUE TO ANXIOUS- OF PATIENTS WITH PARKINSON’S DISEASE" ALCOHOL ABUSE COMORBIDITY?" JOURNAL NEUROCHEMICAL RESEARCH, PLENUM OF CLINICAL PSYCHOPHARMACOLOGY, PRESS, NEW YORK, US, vol. 28, no. 8, August WILLIAMS AND WILKINS, US, vol. 22, no. 6, 2002, 2003 (2003-08), pages 1145-1150, XP009031514 pages 584-591, XP009029358 ISSN: 0271-0749 ISSN: 0364-3190 • ADLER L ET AL: "PRAXIS DER STATIONAEREN • DATABASE EMBASE [Online] ELSEVIER AKUTBEHANDLUNG VON MANIEN SCIENCE PUBLISHERS, AMSTERDAM, NL; 1999, RETROSPEKTIVE ETCHEPAREBORDA M C: "Neurocognitive and VERGLEICHSUNTERSUCHUNG AN JE 100 pharmacological approach to specific learning PATIENTEN ZWEIER PSYCHIATRISCHER disorders" XP002312308 Database accession no. ZENTREN PRACTICE OF IN-PATIENT ACUTE EMB-2000050033 & REVISTA DE NEUROLOGIA TREATMENT OF MANIAS" FORTSCHRITTE DER 1999 SPAIN, vol. 28, no. SUPPL. 2, 1999, pages NEUROLOGIE PSYCHIATRIE, STUTTGART, DE, S81-S93, ISSN: 0210-0010 vol. 62, no. 12, 1994, pages 479-488, XP009029389 • WIRZ-JUSTICE A ET AL: "HALOPERIDOL ISSN: 0720-4299 DISRUPTS, CLOZAPINE REINSTATES THE • ANSOMS C ET AL: "Sleep disorders in patients CIRCADIAN REST-ACTIVITY CYCLE IN A with severe mental depression: double-blind PATIENT WITH EARLY-ONSET ALZHEIMER placebo-controlled evaluation of the value of DISEASE" ALZHEIMER DISEASE AND pipamperone (Dipiperon)." ACTA ASSOCIATED DISORDERS, RAVEN PRESS, NEW PSYCHIATRICA SCANDINAVICA. FEB 1977, vol. YORK, NY, US, vol. 14, no. 4, 2000, pages 212-215, 55, no. 2, February 1977 (1977-02), pages 116-122, XP009029353 ISSN: 0893-0341 XP009041169 ISSN: 0001-690X • FAHS H ET AL: "THYMOREGULATEURS DANS • LEYSEN J E ET AL: "RECEPTOR INTERACTI0NS L’AGITATION ET LES TROUBLES DU OF NEW ANTIPSYCHOTICS: RELATION TO COMPORTEMENT CHEZ LE SUJET DEMENT A PHARMACODYNAMIC AND CLINICAL EFFECTS" PROPOS DE HUIT CAS ANTICONVULSIVANTS INTERNATIONAL JOURNAL OF PSYCHIATRY IN AND AGGRESSIVE BEHAVIORS IN CLINICAL PRACTICE, MARTIN DUNITZ, ALZHEIMER’S DISEASE. EIGHT CASES LONDON, GB, vol. 2, no. 1, 1998, pages S03-S17, REPORTS" ENCEPHALE, PARIS, FR, vol. 25, no. XP001009585 ISSN: 1365-1501 2, 1999, pages 169-174, XP009039295 ISSN: • DATABASE BIOSIS [Online] BIOSCIENCES 0013-7006 INFORMATION SERVICE, PHILADELPHIA, PA, • GRÖZINGER M ET AL: "Melperone is an inhibitor US; 1996, SCHOTTE A ET AL: "Risperidone of the CYP2D6 catalyzed O-demethylation of compared with new and reference antipsychotic venlafaxine." PHARMACOPSYCHIATRY. drugs: In vitro and in vivo receptor binding" GERMANY JAN 2003, vol. 36, no. 1, January 2003 XP002290498 Database accession no. (2003-01), pages 3-6, XP009029363 ISSN: PREV199698829913 & 0176-3679 PSYCHOPHARMACOLOGY, vol. 124, no. 1-2, • WERTH ESTHER ET AL: "Decline in long-term 1996, pages 57-73, ISSN: 0033-3158 circadian rest-activity cycle organization in a • VANHOENACKER P ET AL: "EFFICIENT patient with dementia." JOURNAL OF GERIATRIC EXPRESSION OF THE HUMAN DOPAMINE D4.2 PSYCHIATRY AND NEUROLOGY. 2002 SPRING, RECEPTOR: POSITIVE INFLUENCE OF vol. 15, no. 1, April 2002 (2002-04), pages 55-59, PIPAMPERONE ON EXPRESSION LEVELS" XP009042127 ISSN: 0891-9887 ABSTRACTS OF THE SOCIETY FOR • STAHL STEPHEN M ET AL: "Examination of NEUROSCIENCE, SOCIETY FOR nighttime sleep-related problems during double- NEUROSCIENCE, WASHINGTON, DC, US, vol. 26, blind, placebo-controlled trials of galantamine in no. 1/2, 2000, page 1, XP001181469 ISSN: patients with Alzheimer’s disease." CURRENT 0190-5295 MEDICAL RESEARCH AND OPINION. APR 2004, • VIJVER VAN DE D A M C ET AL: vol. 20, no. 4, April 2004 (2004-04), pages 517-524, "ANTIPSYCHOTICS AND PARKINSON’S XP009041652 ISSN: 0300-7995 DISEASE: ASSOCIATION WITH DISEASE AND • DATABASE BIOSIS [Online] BIOSCIENCES DRUG CHOICE DURING THE FIRST 5 YEARS OF INFORMATION SERVICE, PHILADELPHIA, PA, ANTIPARKINSONIAN DRUG TREATMENT" US; 1995, MELTZER HERBERT Y ET AL: "Plasma EUROPEAN JOURNAL OF CLINICAL clozapine levels and the treatment of L-DOPA- PHARMACOLOGY, SPRINGER VERLAG, DE, vol. induced psychosis in Parkinson’s disease. A 58, no. 7, 2002, pages 157-161, XP009033980 high potency effect of clozapine" XP002290499 ISSN: 0031-6970 Database accession no. PREV199598192811 & NEUROPSYCHOPHARMACOLOGY, vol. 12, no. 1, 1995, pages 39-45, ISSN: 0893-133X

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• MUENCHAU A ET AL: "PHARMACOLOGICAL • "Pipamperone dichlorhydrate"[Online] 2000, TREATMENT OF PARKINSON’S DISEASE" pages 1-4, Retrieved from the Internet: URL:http: POSTGRADUATE MEDICAL JOURNAL, //www.biam2.org/www/Sub2783.html> [retrieved MCMILLAN PRESS, BASINGSTOKE, GB, vol. 76, on 2007] no. 900, October 2000 (2000-10), pages 602-610, • ’Médicaments psychotropes: posologies chez XP009034316 ISSN: 0032-5473 l’enfant et l’adolescent’, [Online] 2001, pages 1 - • FALTRACO F ET AL: "AKTUELLE 3 Retrieved from the Internet: DEMENZ CURRENT THERAPEUTICAL [retrieved on 2007-00-00] STRATEGIES IN DEMENTIA" NEUROLOGIE UND • HEISER P.; REMSCHMIDT H.: ’SELECTIVE REHABILITATION, BONN, DE, vol. 9, no. 1, 2003, SEROTONIN REUPTAKE INHIBITORS AND pages 15-22, XP009041267 ISSN: 0947-2177 NEWER ANTIDEPRESSIVE SUBSTANCES IN • MONTGOMERY S.A.; ANDERSEN H.F.: CHILD AND ADOLESCENT PSYCHIATRY. DIE ’Escitalopram versus venlafaxine XR in the SELEKTIVEN SEROTONIN- treatment of depression’ INTERNATIONAL WIEDERAUFNAHMEHEMMER UND DIE CLINICAL PHARMACOLOGY vol. 21, no. 5, 2006, NEUEREN ANTIDEPRESSIVA-SUBSTANZEN IN pages 297 - 309 DER KINDER- UND JUGENDPSYCHIATRIE’ • KHAN ARIF; WARNER HEATHER A.; BROWN ZEITSCHRIFT FUER KINDER- UND WALTER A.: ’Symptom reduction and suicide risk JUGENDPSYCHIATRIE UNDPSYCHOTHERAPIE in patients treated with placebo in antidepressant vol. 30, no. 3, 2002, pages 173 - 183, XP009076880 clinical trials: An analysis of the Food and Drug • CARLIER P.R. ET AL: ’Synthesis of a Potent Wide- Administration database’ ARCHIVES OF Spectrum Serotonin-, Norepinephrine-, GENERAL PSYCHIATRY vol. 57, no. 4, 2000, Dopamine-Reuptake Inhibitor (SNDRI) and a pages 311 - 317 Species-Selective Dopamine-Reuptake Inhibitor • MOORE NICHOLAS; VERDOUX HÉLÈNE; Based on the Gamma-Amino Alcohol Functional FANTINO BRUNO: ’Prospective, multicentre, Group’ BIOORGANIC & MEDICINAL CHEMISTRY randomized, double-blind study of the efficacy of LETTERS vol. 8, no. 5, 1998, pages 487 - 492 escitalopram versus citalopram in outpatient • MAINA GIUSEPPE ET AL: ’ANTIPSYCHOTIC treatment of major depressive disorder’ AUGMENTATION FOR TREATMENT RESISTANT INTERNATIONAL CLINICAL OBSESSIVE-COMPULSIVE DISORDER: WHAT IF PSYCHOPHARMACOLOGY vol. 20, no. 3, 2005, ANTIPSYCHOTIC IS DISCONTINUED?’ pages 131 - 137 INTERNATIONAL CLINICAL • WIELING W. ET AL: ’INITIAL ORTHOSTATIC PSYCHOPHARMACOLOGY vol. 18, no. 1, 01 HYPOTENSION AS A CAUSE OF RECURRENT January 2003, pages 23 - 28, XP009078546 SYNCOPE: A CASE REPORT’ CLINICAL AUTONOMIC RESEARCH vol. 11, no. 4, 2001, Remarks: page 270, XP009039296 The file contains technical information submitted after • FOUKS D. ET AL: ’TRAITEMENT DES TROUBLES the application was filed and not included in this CARACTERIELS PAR UNE NOUVELLE specification BUTYROPHENOME: LE R. 3345 OU PIPAMPERONE//TREATMENT OF CHARACTER DISORDERS WITH A NEW BUTYROPHENONE: R. 3345 OR PIPAMPERONE’ ANNALES MEDICO- PSYCHOLOGIQUES vol. 124, no. 5, 1966, pages 677 - 681, XP009028328

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