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Claims for Patent: 8,404,744

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Claims for Patent: 8,404,744

Title:Methods of treatment and pharmaceutical composition
Abstract: The invention relates a pharmaceutical composition comprising a combination of (i) the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof and (ii) a NEP inhibitor or a pharmaceutically acceptable salt thereof and optionally a pharmaceutically acceptable carrier and to a method for the treatment or prevention of selected conditions or diseases.
Inventor(s): Ksander; Gary M (Milford, NJ), Webb; Randy L (Flemington, NJ)
Assignee: Novartis AG (Basel, CH)
Application Number:13/328,769
Patent Claims: 1. A pharmaceutical composition comprising: (i) the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof; (ii) the NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2- R-methylbutanoic acid ethyl ester or a pharmaceutically acceptable salt thereof, or (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid or a pharmaceutically acceptable salt thereof; and (iii) a pharmaceutically acceptable carrier; wherein said (i) AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof and said (ii) NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methylbu- tanoic acid ethyl ester or a pharmaceutically acceptable salt thereof, or (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid or a pharmaceutically acceptable salt thereof, are administered in combination in a 1:1 ratio.

2. The pharmaceutical composition of claim 1 wherein (ii) said NEP inhibitor is N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methylbu- tanoic acid ethyl ester.

3. The pharmaceutical composition of claim 1 wherein (ii) said NEP inhibitor is a pharmaceutically acceptable salt of N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methylbu- tanoic acid ethyl ester.

4. The pharmaceutical composition of claim 1 wherein (ii) said NEP inhibitor is (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid.

5. The pharmaceutical composition of claim 1 wherein (ii) said NEP inhibitor is a pharmaceutically acceptable salt of (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid.

6. A pharmaceutical composition comprising: (i) the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof; (ii) the NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2- R-methylbutanoic acid ethyl ester or a pharmaceutically acceptable salt thereof, or (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid or a pharmaceutically acceptable salt thereof; and (iii) a pharmaceutically acceptable carrier; wherein said (i) AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof and said (ii) NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methylbu- tanoic acid ethyl ester or a pharmaceutically acceptable salt thereof, or (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid or a pharmaceutically acceptable salt thereof, are present in a 1:1 ratio.

7. A pharmaceutical composition consisting of: (i) the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof; (ii) the NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2- R-methylbutanoic acid ethyl ester or a pharmaceutically acceptable salt thereof, or (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid or a pharmaceutically acceptable salt thereof; and (iii) a pharmaceutically acceptable carrier; wherein said (i) AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof and said (ii) NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methylbu- tanoic acid ethyl ester or a pharmaceutically acceptable salt thereof, or (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid or a pharmaceutically acceptable salt thereof, are present in a 1:1 ratio.

8. The pharmaceutical composition of claim 3 wherein the pharmaceutically acceptable salt is selected from the group consisting of the sodium salt, the triethanolamine salt and the tris(hydroxymethyl)aminomethane salt.

9. The pharmaceutical composition of claim 5 wherein the pharmaceutically acceptable salt is selected from the group consisting of the sodium salt, the triethanolamine salt and the tris(hydroxymethyl)aminomethane salt.

10. The pharmaceutical composition of claim 1 in the form of a capsule or tablet.
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