(12) Translation of european patent specification

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1 (12) Translation of european patent specification (11) NO/EP B1 (19) NO NORWAY (1) Int Cl. A61K 9/14 ( ) A61K 9/72 ( ) A61K 31/46 ( ) A61K 4/06 ( ) Norwegian Industrial Property Office (21) Translation Published (80) Date of The European Patent Office Publication of the Granted Patent (86) European Application Nr (86) European Filing Date (87) The European Application s Publication Date (30) Priority , EP, (84) Designated Contracting States: Designated Extension States: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO SE SI SK TR AL BA RS (73) Proprietor Almirall, S.A., Ronda del General Mitre 11, Barcelona, ES-Spania (72) Inventor LAMARCA CASADO, Rosa, C/de Ia Llacuna , 1 3a, E Barcelona, ES-Spania DE MIQUEL SERRA, Gonzalo, Adva. Diagonal 11, 3 3a, E Barcelona, ES- Spania (74) Agent or Attorney Bryn Aarflot AS, Postboks 449 Sentrum, 0104 OSLO, Norge (4) Title INHALATION COMPOSITION CONTAINING ACLIDINIUM FOR TREATMENT OF ASTHMA (6) References Cited: WO-A-02/36106 US-A US-A G. JOOS ET AL.: "Bronchodilator effects of aclidinium bromide, a novel long-acting anticholinergic, in COPD patients: a phase II study", [Online] 16 September 2007 ( ), pages 209S-210S, XP Retrieved from the Internet: URL:http://www.ersnet.org/learning_resourc es_player/abstract_print_07/files/138.pdf> [retrieved on ] "Actualites pharmaceutiques", ARCHIVES DE PEDIATRIE, ELSEVIER, PARIS, FR, vol. 13, no. 12, 1 December 2006 ( ), pages , XP , ISSN: X, DOI: /J.ARCPED [retrieved on ] SINGH D ET AL: "A randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients", PULMORNARY PHARMACOLOGY & THERAPEUTICS, ACADEMIC PRESS, GB, vol. 2, no. 3, 29 March 2012 ( ), pages , XP , ISSN: , DOI: /J.PUPT [retrieved on ]

2 Enclosed is a translation of the patent claims in Norwegian. Please note that as per the Norwegian Patents Acts, section 66i the patent will receive protection in Norway only as far as there is agreement between the translation and the language of the application/patent granted at the EPO. In matters concerning the validity of the patent, language of the application/patent granted at the EPO will be used as the basis for the decision. The patent documents published by the EPO are available through Espacenet (http://worldwide.espacenet.com) or via the search engine on our website here: https://search.patentstyret.no/ NO/EP22628

3 NO/EP Patentkrav Farmasøytisk sammensetning omfattende aklidinium i form av et tørt pulver av et farmasøytisk akseptabelt salt i blanding med en farmasøytisk akseptabel tørrpulverbærer, som tilveiebringer en tilmålt nominell dose av aklidinium som tilsvarer 200 mikrogram (pluss/minus 10 %) aklidiniumbromid for anvendelse ved inhalering i behandlingen av astma. 2. Farmasøytisk sammensetning for anvendelse ifølge krav 1, i form av en enkeltdosetørrpulverformulering omfattende en enkelt tilmålt nominell dose av aklidinium som tilsvarer 200 mikrogram (pluss/minus 10 %) aklidiniumbromid. 3. Farmasøytisk sammensetning for anvendelse ifølge krav 1, i form av en multidosetørrpulverformulering for administrering i en multidosetørrpulverinhalatoranordning kalibrert til å tilveiebringe en tilmålt nominell dose av aklidinium som tilsvarer 200 mikrogram (pluss/minus 10 %) aklidiniumbromid. 4. Farmasøytisk sammensetning for anvendelse ifølge hvilket som helst av de foregående kravene hvori (a) det farmasøytisk akseptable saltet av aklidinium er aklidiniumbromid, og/eller (b) den farmasøytisk akseptable bæreren er laktosepartikler. 20. Farmasøytisk sammensetning for anvendelse ifølge hvilke som helst av de foregående kravene, hvori vektforholdet mellom aklidinium og bæreren er fra 1:0 til 1: Farmasøytisk sammensetning for anvendelse ifølge krav, hvori vektforholdet mellom aklidinium og bæreren er fra 1:100 til 1: Farmasøytisk sammensetning for anvendelse ifølge hvilke som helst av de foregående kravene hvori (a) den gjennomsnittlige partikkeldiameteren til aklidinium er innen 2- µm, og/eller (b) bærerpartiklene har en d10 på µm, en d0 på µm, og d90 på µm. 8. Farmasøytisk sammensetning for anvendelse ifølge hvilke som helst av de foregående kravene, hvori den farmasøytiske sammensetningen videre omfatter en effektiv mengde av én eller flere ytterligere aktive midler valgt fra β2-agonister, PDE IV-hemmere, og kortikosteroider.

4 NO/EP Farmasøytisk sammensetning for anvendelse ifølge krav 8 hvori det ytterligere aktive midlet velges fra formoterol, salmeterol, budesonid og flutikasonpropionat, i fri eller farmasøytisk akseptabel saltform Farmasøytisk sammensetning for anvendelse ifølge krav 9 hvori (a) det ytterligere aktive midlet er formoterolfumarat i en mengde på -2 mikrogram per dose, eller (b) det ytterligere aktive midlet i formoterolfumarat i en mengde på 6 mikrogram per dose, eller (c) det ytterligere aktive midlet er formoterolfumarat i en mengde på 12 mikrogram per dose. 11. Aklidinium i fri eller farmasøytisk akseptabel saltform for anvendelse i behandling av astma hos en pasient som har behov for slik behandling, anvendelsen er omfattende administrering ved inhalering én eller to ganger daglig i en tilmålt nominell dose av aklidinium som tilsvarer 200 mikrogram (pluss/minus 10 %) aklidiniumbromid. 12. Aklidinium i fri eller farmasøytisk akseptabel saltform for anvendelse ifølge krav 11, anvendelsen er omfattende administrering av en farmasøytiske sammensetning ifølge hvilke som helst av kravene Aklidinium i fri eller farmasøytisk akseptabel saltform for anvendelse ifølge krav 11 eller 12, anvendelsen er videre omfattende administrering av en effektiv mengde av ett eller flere ytterligere aktive midler valgt fra β2-agonister, PDE IVhemmere og kortikosteroider. 14. Aklidinium i fri eller farmasøytisk akseptabel saltform for anvendelse ifølge krav 13, hvori det ytterligere aktive midlet er valgt fra formoterol, salmeterol, budesonid, og flutikasonpropionat, i fri eller farmasøytisk akseptabel saltform Aklidinium i fri eller farmasøytisk akseptabel saltform for anvendelse ifølge krav 14, hvori (a) det ytterligere aktive midlet er formoterolfumarat i en mengde på -2 mikrogram per dose, eller (b) det ytterligere aktive midlet i formoterolfumarat i en mengde på 6 mikrogram per dose, eller (c) det ytterligere aktive midlet er formoterolfumarat i en mengde på 12 mikrogram per dose. 16. Anvendelse av aklidinium i fri eller farmasøytisk akseptabel saltform i fremstillingen av et medikament for behandling av astma hos en pasient som har behov for slik behandling, anvendelsen er omfattende administrering ved inhalering én eller to ganger daglig av en tilmålt nominell dose av aklidinium som tilsvarer 200 mikrogram (pluss/minus 10 %) aklidiniumbromid.

5 NO/EP Anvendelse ifølge krav 16, hvori anvendelsen omfatter administrering av en farmasøytisk sammensetning som definert i hvilket som helst av kravene 1 til Multidosetørrpulverinhalatoranordning omfattende aklidinium, som kalibreres til å levere, ved aktivering, en tilmålt nominell dose av aklidinium som tilsvarer 200 mikrogram (pluss/minus 10 %) aklidiniumbromid.

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