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Claims for Patent: 8,796,331

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Claims for Patent: 8,796,331

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 a condition or disease selected from the group consisting of hypertension, heart failure, such as (acute and chronic) congestive heart failure, left ventricular dysfunction and hypertrophic cardiomyopathy, diabetic cardiac myopathy, supraventricular and ventricular arrhythmias, atrial fibrillation, atrial flutter, detrimental vascular remodeling, myocardial infarction and its sequelae, atherosclerosis, angina (whether unstable or stable), renal insufficiency (diabetic and non-diabetic), heart failure, angina pectoris, diabetes, secondary aldosteronism, primary and secondary pulmonary hypertension, renal failure conditions, diabetic retinopathy, the management of other vascular disorders, cognitive dysfunction, comprising administering a therapeutically effective amount of tire pharmaceutical composition to mammal in need thereof.
Inventor(s): Ksander; Gary Michael (Milford, NJ), Webb; Randy Lee (Flemington, NJ)
Assignee: Novartis AG (Basel, CH)
Application Number:13/687,659
Patent Claims: 1. A method for the treatment of a condition or disease selected from the group consisting of hypertension and heart failure, comprising administering to a patient in need thereof a therapeutically effective amount of the combination 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-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; and wherein said components (i) and (ii) are administered in one unit dose form or in two separate unit dose forms.

2. The method of claim 1 wherein components (i) and (ii) are administered in one unit dose form.

3. The method of claim 1 wherein components (i) and (ii) are administered separately in two separate unit dose forms.

4. The method of claim 1 wherein the condition or disease is hypertension.

5. The method of claim 1 wherein the condition or disease is heart failure.

6. The method of claim 2, wherein the one unit dosage form is for oral administration.

7. The method of claim 2, wherein the one unit dosage form is a tablet or capsule.

8. The method of claim 7, wherein the tablet is a coated tablet.

9. The method of claim 3, wherein the two separate unit dose forms are for oral administration.

10. The method of claim 3, wherein the two separate unit dose forms are in a kit.
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