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4-Traders Homepage  >  Equities  >  Swiss Exchange  >  Novartis AG    NOVN   CH0012005267

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Novartis : Patent Issued for Pharmaceutical Combinations (USPTO 9446043)

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09/29/2016 | 07:02pm CEST

By a News Reporter-Staff News Editor at Pharma Business Week -- A patent by the inventors Porter, Dale (Cambridge, MA); Emery, Caroline (Cambridge, MA); Tan, Lujian (Cambridge, MA); Yerramilli-Rao, Padmaja (Cambridge, MA), filed on November 26, 2013, was published online on September 20, 2016, according to news reporting originating from Alexandria, Virginia, by NewsRx correspondents (see also Pharmaceutical Companies).

Patent number 9446043 is assigned to Novartis AG (Basel, CH).

The following quote was obtained by the news editors from the background information supplied by the inventors: "Uveal melanoma is a malignant neoplasm that arises in the pigmented portions of the eye, specifically in the iris, ciliary body or choroid. Therapy for uveal melanoma includes local therapy with enucleation or brachytherapy. Approximately half of patients develop metastatic disease, typically to the liver and often to lung and bone, and the incidence of new metastases continues to increase with time suggesting that the disease is slow growing. The outcome for patients with metastatic disease is dismal. No therapy for this disease has been approved to date.

"Mutations affecting either one of two genes that encode G protein alpha subunits of heterotrimeric G protein complexes (GNAQ and GNA11) were discovered in the vast majority of tumors (Van Raamsdonk C D, Bezrookove V, Green G, et al, Nature (2009); 457:599-601 and Van Raamsdonk C D, Griewank K G, et al (2010), N Eng J Med; 363:2191-9). The mutations identified are typical of activating mutations affecting other G proteins.

"In spite of numerous treatment options for patients with cancer, there remains a need for effective and safe therapeutic agents and a need for new combination therapies that can be administered for the effective long-term treatment of cancer.

"The present inventors have now found that inhibition of the signaling cascade downstream of these G proteins may be useful for the treatment of a proliferative disease such as cancer, e.g. a tumor with a Ga mutation (GNA11/GNAQ), and in particular, uveal melanoma, metastatic uveal melanoma, and GNAQ or GNA11 mutant uveal melanoma.

"It has now been found that a combination of a protein kinase C (PKC) inhibitor compound and a MEK inhibitor compound is effective for the delay of progression or treatment of a proliferative disease, especially uveal melanoma, metastatic uveal melanoma, and GNAQ or GNA11 mutant uveal melanoma.

"It has now been surprisingly discovered that the combination of an effective amount of a protein kinase C (PKC) inhibitor, e.g. 3-(1H-indol-3-yl)-4-[2-(4-methyl-piperazin-1-yl)-quinazolin-4-yl]-1H-pyrr- ole-2,5-dione, or a pharmaceutically acceptable salt thereof, e.g. the acetate thereof, with an effective amount of at least one MEK inhibitor compound, e.g. 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethoxy)-amide or (S)-5-fluoro-2-(2-fluoro-4-(methylthio)phenylamino)-N-(2-hydroxypropoxy)-- 1-methyl-6-oxo-1,6-dihydropyridine-3-carboxamide, more preferably, 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethoxy)-amide, results in unexpected improvement in the treatment of proliferative diseases, particularly cancer, and more particularly uveal melanoma, metastatic uveal melanoma, and GNAQ or GNA11 mutant uveal melanoma.

"When administered simultaneously, sequentially or separately, the preferred protein kinase C (PKC) inhibitor compound and the preferred MEK inhibitor compound interact in a synergistic manner to strongly inhibit cell proliferation and are surprisingly efficacious in uveal melanoma models This unexpected synergistic reaction allows reduction in the dose required for each compound, leading to a reduction in the side effects and enhancement of the long-term clinical effectiveness of the compounds in treatment."

In addition to the background information obtained for this patent, NewsRx journalists also obtained the inventors' summary information for this patent: "The invention provides pharmaceutical combinations and therapeutic methods which may be useful for inhibiting the cell growth of a tumor with a Ga mutation (GNA11/GNAQ) and for treating proliferative diseases, particularly cancer, and more particularly uveal melanoma, metastatic uveal melanoma, and GNAQ or GNA11 mutant uveal melanoma.

"The present invention provides pharmaceutical combinations comprising: (a) a protein kinase C (PKC) inhibitor, or a pharmaceutically acceptable salt thereof, and (b) at least one mitogen activated protein kinase (MEK) inhibitor and optionally at least one pharmaceutically acceptable carrier.

"The present invention also provides pharmaceutical combinations consisting of: (a) a protein kinase C (PKC) inhibitor, or a pharmaceutically acceptable salt thereof, and (b) one mitogen activated protein kinase (MEK) inhibitor and optionally at least one pharmaceutically acceptable carrier.

"In the above combinations, the PKC inhibitor compound may be selected from the group consisting of 3-(1H-indol-3-yl)-4-[2-(4-methyl-piperazin-1-yl)-quinazolin-4-yl]-1H-pyrr- ole-2,5-dione; 3-(1.H.-indol-3-yl)-4-[2-(piperazin-1-yl)-quinazolin-4-yl]-1H-pyrrole-2,5- -dione; 3-[2-chloro-7-[(dimethylamino)methyl]-1-naphthalenyl]-4-[7-[2-(2-m- ethoxyethoxyl)ethoxy]-1H-indol-3-yl]-1H-pyrrole-2,5-dione; 3-[3-(4,7-diaza-spiro[2,5]oct-7-yl)-isoquinolin-1-yl]-4-(7-methyl-1H-indo- l-3-yl)-pyrrole-2,5-dione, (9S)-9-[(dimethylamino)methyl]-6,7,10,11-tetrahydro-9H, 18H-5,21:12,17-dimethenodibenzo-[e,k]pyrrolo[3,4-h][1,4,13]oxadiazacycloh- exadecine-18,20(19H)-dione, ruboxistaurin, and and 12-(2-cyanoethyl)-6,7,12,13-tetrahydro-13-methyl-5-oxo-5H-indolo(2,3-a)py- rrolo(3,4-c)-carbazole, or a pharmaceutically acceptable salt thereof.

"In the above combinations, the MEK inhibitor compound may be independently selected from the PKC inhibitor and may be selected from the group consisting of 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethoxy)-amide, (S)-5-fluoro-2-(2-fluoro-4-(methylthio)phenylamino)-N-(2-hydroxypropoxy)-- 1-methyl-6-oxo-1,6-dihydropyridine-3-carboxamide, PD0325901, PD-184352, RDEA119, GSK1120212, XL518, AS-701255, AS-701173, AS703026, RDEA436, E6201, R04987655, JTP-74057, RG7167, and RG7420, or a pharmaceutically acceptable salt thereof,

"The present invention also provides a pharmaceutical combination comprising: (a) a protein kinase C (PKC) inhibitor compound 3-(1H-indol-3-yl)-4-[2-(4-methyl-piperazin-1-yl)-quinazolin-4-yl]-1H-pyrr- ole-2,5-dione (COMPOUND A) or a pharmaceutically acceptable salt thereof, and (b) at least one mitogen activated protein kinase (MEK) inhibitor selected from the group comprising 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethoxy)-amide (COMPOUND B), (S)-5-fluoro-2-(2-fluoro-4-(methylthio)phenylamino)-N-(2-hydroxypropoxy)-- 1-methyl-6-oxo-1,6-dihydropyridine-3-carboxamide (COMPOUND C), PD0325901, PD-184352, RDEA119, GSK1120212, XL518, AS-701255, AS-701173, AS703026, RDEA436, E6201, R04987655, JTP-74057, RG7167, or RG7420 or a pharmaceutically acceptable salt thereof, and optionally at least one pharmaceutically acceptable carrier.

"In a preferred embodiment of the present invention, the combination partners are (a) a PKC inhibitor compound 3-(1H-indol-3-yl)-4-[2-(4-methyl-piperazin-1-yl)-quinazolin-4-yl]-1H-pyrr- ole-2,5-dione (COMPOUND A) or a pharmaceutically acceptable salt thereof, and (b) at least one MEK inhibitor compound selected from the group consisting of 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethoxy)-amide (COMPOUND B) or (S)-5-fluoro-2-(2-fluoro-4-(methylthio)phenylamino)-N-(2-hydroxypropoxy)-- 1-methyl-6-oxo-1,6-dihydropyridine-3-carboxamide (COMPOUND C) or a pharmaceutically acceptable salt thereof.

"In another preferred embodiment of the present invention, the combination partners are (a) a PKC inhibitor compound 3-(1H-indol-3-yl)-4-[2-(4-methyl-piperazin-1-yl)-quinazolin-4-yl]-1H-pyrr- ole-2,5-dione (COMPOUND A) or a pharmaceutically acceptable salt thereof, and (b) a MEK inhibitor compound 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethoxy)-amide (COMPOUND B) or a pharmaceutically acceptable salt thereof.

"The present invention further relates to a combined preparation or a pharmaceutical composition comprising (a) a PKC inhibitor compound 3-(1.H.-indol-3-yl)-4-[2-(4-methyl-piperazin-1-yl)-quinazolin-4-yl]-pyrro- le-2,5-dione (COMPOUND A) or a pharmaceutically acceptable salt thereof, and (b) at least one MEK inhibitor selected from the group comprising 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethoxy)-amide (COMPOUND B), (S)-5-fluoro-2-(2-fluoro-4-(methylthio)phenylamino)-N-(2-hydroxypropoxy)-- 1-methyl-6-oxo-1,6-dihydropyridine-3-carboxamide (COMPOUND C), PD0325901, PD-184352, RDEA119, GSK1120212, XL518, AS-701255, AS-701173, AS703026, RDEA436, E6201, R04987655, JTP-74057, RG7167, or RG7420 or a pharmaceutically acceptable salt thereof, and optionally at least one pharmaceutically acceptable carrier. In one embodiment, the present invention relates to a combined preparation which comprises: (i) one or more unit dosage forms of combination partner (a), and (ii) one or more unit dosage forms of combination partner (b).

"The present invention particularly pertains to a pharmaceutical combination comprising (a) a PKC inhibitor compound 3-(1H-indol-3-yl)-4-[2-(4-methyl-piperazin-1-yl)-quinazolin-4-yl]-1H-pyrr- ole-2,5-dione (COMPOUND A) or a pharmaceutically acceptable salt thereof, and (b) at least one MEK inhibitor selected from the group comprising 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethoxy)-amide (COMPOUND B), (S)-5-fluoro-2-(2-fluoro-4-(methylthio)phenylamino)-N-(2-hydroxypropoxy)-- 1-methyl-6-oxo-1,6-dihydropyridine-3-carboxamide (COMPOUND C), PD0325901, PD-184352, RDEA119, GSK1120212, XL518, AS-701255, AS-701173, AS703026, RDEA436, E6201, R04987655, JTP-74057, RG7167, or RG7420 or a pharmaceutically acceptable salt thereof, and optionally at least one pharmaceutically acceptable carrier useful for treating or preventing a proliferative disease in a subject in need thereof.

"The present invention also pertains to a pharmaceutical combination comprising (a) a PKC inhibitor compound 3-(1H-indol-3-yl)-4-[2-(4-methyl-piperazin-1-yl)-quinazolin-4-yl]-1H-pyrr- ole-2,5-dione (COMPOUND A) or a pharmaceutically acceptable salt thereof, and (b) at least one MEK inhibitor selected from the group comprising 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethoxy)-amide (COMPOUND B), (S)-5-fluoro-2-(2-fluoro-4-(methylthio)phenylamino)-N-(2-hydroxypropoxy)-- 1-methyl-6-oxo-1,6-dihydropyridine-3-carboxamide (COMPOUND C), PD0325901, PD-184352, RDEA119, GSK1120212, XL518, AS-701255, AS-701173, AS703026, RDEA436, E6201, R04987655, JTP-74057, RG7167, or RG7420 or a pharmaceutically acceptable salt thereof, and optionally at least one pharmaceutically acceptable carrier for use in the preparation of a pharmaceutical composition or medicament for the treatment or prevention of a proliferative disease in a subject in need thereof.

"The present invention further pertains to the use of a PKC inhibitor 3-(1H-indol-3-yl)-4-[2-(4-methyl-piperazin-1-yl)-quinazolin-4-yl]-1H-pyrr- ole-2,5-dione (COMPOUND A) or a pharmaceutically acceptable salt thereof, in combination with at least one MEK inhibitor selected from the group comprising 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethoxy)-amide (COMPOUND B), (S)-5-fluoro-2-(2-fluoro-4-(methylthio)phenylamino)-N-(2-hydroxypropoxy)-- 1-methyl-6-oxo-1,6-dihydropyridine-3-carboxamide (COMPOUND C), PD0325901, PD-184352, RDEA119, GSK1120212, XL518, AS-701255, AS-701173, AS703026, RDEA436, E6201, R04987655, JTP-74057, RG7167, or RG7420 or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition or medicament for the treatment or prevention of a proliferative disease.

"The present invention relates to a method of treating a subject having a proliferative disease comprising administered to said subject a combination comprising (a) a PKC inhibitor compound 3-(1H-indol-3-yl)-4-[2-(4-methyl-piperazin-1-yl)-quinazolin-4-yl]-1H-pyrr- ole-2,5-dione (COMPOUND A) or a pharmaceutically acceptable salt thereof, and (b) a MEK inhibitor selected from the group comprising 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethoxy)-amide (COMPOUND B), (S)-5-fluoro-2-(2-fluoro-4-(methylthio)phenylamino)-N-(2-hydroxypropoxy)-- 1-methyl-6-oxo-1,6-dihydropyridine-3-carboxamide (COMPOUND C), PD0325901, PD-184352, RDEA119, GSK1120212, XL518, AS-701255, AS-701173, AS703026, RDEA436, E6201, R04987655, JTP-74057, RG7167, or RG7420 or a pharmaceutically acceptable salt thereof, and optionally at least one pharmaceutically acceptable carrier in a quantity, which is jointly therapeutically effective against a proliferative disease.

"The present invention further provides a commercial package comprising as therapeutic agents a combination comprising (a) a PKC inhibitor compound 3-(1H-indol-3-yl)-4-[2-(4-methyl-piperazin-1-yl)-quinazolin-4-yl]-1H-pyrr- ole-2,5-dione (COMPOUND A) or a pharmaceutically acceptable salt thereof, and (b) a MEK inhibitor selected from the group comprising 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethoxy)-amide (COMPOUND B), (S)-5-fluoro-2-(2-fluoro-4-(methylthio)phenylamino)-N-(2-hydroxypropoxy)-- 1-methyl-6-oxo-1,6-dihydropyridine-3-carboxamide (COMPOUND C), PD0325901, PD-184352, RDEA119, GSK1120212, XL518, AS-701255, AS-701173, AS703026, RDEA436, E6201, R04987655, JTP-74057, RG7167, or RG7420 or a pharmaceutically acceptable salt thereof, together with instructions for simultaneous, separate or sequential administration thereof for use in the delay of progression or treatment of a proliferative disease.

"The above combinations are also provided for simultaneous, separate or sequential administration, in particular for treating or preventing a proliferative disease.

"The proliferative disease is cancer, and more particularly uveal melanoma, metastatic uveal melanoma, GNAQ or GNA11 mutant uveal melanoma and cancer, and more particularly uveal melanoma, metastatic uveal melanoma, and GNAQ or GNA11 mutant metastatic uveal melanoma."

URL and more information on this patent, see: Porter, Dale; Emery, Caroline; Tan, Lujian; Yerramilli-Rao, Padmaja. Pharmaceutical Combinations. U.S. Patent Number 9446043, filed November 26, 2013, and published online on September 20, 2016. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9446043.PN.&OS=PN/9446043RS=PN/9446043

Keywords for this news article include: Pharmaceutical Companies, Cancer, Therapy, Genetics, Melanoma, Oncology, Proteomics, Novartis AG, Protein Kinase C, Enzymes and Coenzymes, Protein-Serine-Threonine Kinases, Mitogen-Activated Protein Kinases, Phosphotransferases (Alcohol Group Acceptor), Intracellular Signaling Peptides and Proteins.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2016, NewsRx LLC

(c) 2016 NewsRx LLC, source Health Newsletters

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Sales 2016 48 896 M
EBIT 2016 11 366 M
Net income 2016 7 821 M
Debt 2016 14 751 M
Yield 2016 3,51%
P/E ratio 2016 23,39
P/E ratio 2017 21,38
EV / Sales 2016 4,65x
EV / Sales 2017 4,51x
Capitalization 212 589 M
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