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1. (WO2007009404) RH-EPO NASAL FORMULATIONS WITH LOW SIALIC ACID CONCENTRATION FOR THE TREATMENT OF DISEASES OF THE CENTRAL NERVOUS SYSTEM
Latest bibliographic data on file with the International Bureau

Pub. No.: WO/2007/009404 International Application No.: PCT/CU2006/000007
Publication Date: 25.01.2007 International Filing Date: 27.07.2006
IPC:
A61K 9/72 (2006.01) ,A61K 38/18 (2006.01) ,A61P 9/10 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
72
for smoking or inhaling
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38
Medicinal preparations containing peptides
16
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17
from animals; from humans
18
Growth factors; Growth regulators
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
9
Drugs for disorders of the cardiovascular system
10
for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Applicants:
CENTRO DE INVESTIGACIÓN Y DESARROLLO DE MEDICAMENTOS (CIDEM) [CU/CU]; Calle 26 No.1605 entre Boyeros y Puentes Grandes, Nuevo Vedado, Plaza, C.P.: 10400 Ciudad de La Habana, CU (AllExceptUS)
MUÑOZ CERNADA, Adriana [CU/CU]; CU (UsOnly)
GARCÍA RODRÍGUEZ, Julio César [CU/CU]; CU (UsOnly)
NUÑEZ FIGUEREDO, Yanier [CU/CU]; CU (UsOnly)
PARDO RUIZ, Zenia [CU/CU]; CU (UsOnly)
GARCÍA SELMAN, Jorge Daniel [CU/CU]; CU (UsOnly)
SOSA TESTÉ, Iliana [CU/CU]; CU (UsOnly)
CURBELO RODRÍGUEZ, David [CU/CU]; CU (UsOnly)
CRUZ RODRÍGUEZ, Janette [CU/CU]; CU (UsOnly)
SUBIROS MARTÍNEZ, Nelvys [CU/CU]; CU (UsOnly)
Inventors:
MUÑOZ CERNADA, Adriana; CU
GARCÍA RODRÍGUEZ, Julio César; CU
NUÑEZ FIGUEREDO, Yanier; CU
PARDO RUIZ, Zenia; CU
GARCÍA SELMAN, Jorge Daniel; CU
SOSA TESTÉ, Iliana; CU
CURBELO RODRÍGUEZ, David; CU
CRUZ RODRÍGUEZ, Janette; CU
SUBIROS MARTÍNEZ, Nelvys; CU
Agent:
DEL PORTILLO DE JUAN, Ingrid; Ave. 1ra # 1001 Esq. 10, Miramar, Ciudad de La Habana, Cuba Ciudad de La Habana 11300, CU
Priority Data:
2005-013822.07.2005CU
Title (EN) RH-EPO NASAL FORMULATIONS WITH LOW SIALIC ACID CONCENTRATION FOR THE TREATMENT OF DISEASES OF THE CENTRAL NERVOUS SYSTEM
(ES) FORMULACIONES NASALES DE EPORH CON BAJO CONTENIDO DE ÁCIDO SIÁLICO PARA EL TRATAMIENTO DE ENFERMEDADES DEL SISTEMA NERVIOSO CENTRAL.
(FR) FORMULATIONS NASALES D'EPORH A FAIBLE TENEUR EN ACIDE SIALIQUE UTILISEES DANS LE TRAITEMENT DE MALADIES DU SYSTEME NERVEUX CENTRAL
Abstract:
(EN) The invention relates to the biopharmaceutical industry and, in particular, to the development of a medicament which is intended for the treatment of cerebrovascular, neurodegenerative and psychiatric diseases and which contains, by way of active principle, recombinant human erythropoietin (rh-Epo) with a low sialic acid concentration. During rh-Epo production, the glycoprotein is obtained with a different sialic acid concentration when less than 40 % of the molecule thereof is protected with (basic) sialic acid, in which case it is not biologically active by systemic route and is inactivated by hepatic enzymes. Surprisingly, it was found that nasally-administered basic rh-Epo has greater therapeutic benefits than the acid. The inventive basic rh-Epo nasal formulations include bioadhesive polymers which increase the residence time in the nasal cavity, thereby enhancing the therapeutic effect thereof. Said formulations also include other auxiliary substances, such as preservative substances, surfactants, pH regulators, isotonising agents and protein stabilisers.
(ES) La presente invención se relaciona con la Industria Biofarmacéutica y en particular con el desarrollo de un medicamento para el tratamiento de las enfermedades cerebrovasculares, neurodegenerativas y siquiátricas que contiene como principio activo Eritropoyetina humana recombinante (EPOrh) con bajo contenido de ácido siálico. Durante la producción de EPOrh se obtiene esta glicoproteína con diferente contenido de ácido siálico cuando presenta menos de un 40% de su molécula protegida con ácido siálico (básica), no es biológicamente activa por vía sistémica, es inactivada por enzimas hepáticas. Sorprendentemente hemos encontrado que la EPOrh básica administrada por vía nasal tiene utilidades terapéuticas superiores a la ácida. Las formulaciones nasales de EPOrh básica que se presentan incorporan polímeros bioadhesivos que incrementan el tiempo de residencia en la cavidad nasal potenciando su efecto terapéutico, se incluyen además otras sustancias auxiliares tales como, sustancias preservantes, tenso activos, reguladores de pH, agentes isotonizantes y estabilizadores de proteína.
(FR) La présente invention concerne l'industrie biopharmaceutique et, en particulier, la mise au point d'un médicament utilisé dans le traitement des maladies cérébro-vasculaires, neurodégénératives et psychiatriques, contenant comme principe actif l'érythropoïétine humaine de recombinaison (EPOrh) avec une faible teneur en acide sialique. Au cours de la production de l'EPOrh, on obtient cette glycoprotéine avec une teneur en acide sialique différente lorsque moins de 40 % de sa molécule est protégée avec de l'acide sialique (de base). Elle n'est pas biologiquement active par voie systémique, et désactivée par des enzymes hépatiques. Curieusement, on a découvert que l'EPOrh de base administrée par voie nasale présente des utilités thérapeutiques supérieures à l'acide. Les formulations nasales d'EPOrh de base de l'invention incorporent des polymères bioadhésifs augmentant la durée de résidence dans la cavité nasale, et améliorant son effet thérapeutique. Lesdites formulations contiennent, de plus, d'autres substances auxiliaires telles que des substances de conservation, des tensioactifs, des régulateurs de pH, des agents isotoniques et des stabilisants de protéine.
Designated States: AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LV, LY, MA, MD, MG, MK, MN, MW, MX, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LT, LU, LV, MC, NL, PL, PT, RO, SE, SI, SK, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG)
Publication Language: Spanish (ES)
Filing Language: Spanish (ES)
Also published as:
MXMX/a/2008/000997EP1997483BRPI0615541CN101296692CA2616156CN105435212
AU2006272217AU2013200099ES2682619