Compositions comprising eicosapentaenoic acid and mipomersen and methods of use thereof

• US 10,167,467 B2
• Filed: 01/19/2017
• Issued: 01/01/2019
• Est. Priority Date: 02/13/2013
• Status: Active Grant

• Current Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Original Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Inventors: Zakrzewski, Joseph S.
• Primary Examiner(s): Zara, Jane J
• Application Number:
  US15/410,249
• Publication Number:
  US 20170136055A1
• Time in Patent Office: 712 Days
• Field of Search: 435 61, 435 911, 435 9131, 435455, 435458, 514 1, 514 2, 514 44, 536 231, 536 245
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/202 having three or more double bonds, e.g. linolenic eicosanoids, e.g. leukotrienes A61K31/557
• CPC Class Codes: A61K 31/232 having three or more double bonds, e.g. etretinate
• CPC Class Codes: A61K 31/7125 Nucleic acids or oligonucleotides having modified internucleoside linkage, i.e. other than 3'-5' phosphodiesters
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: C12N 15/113 Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing when used in plants C12N15/8218
• CPC Class Codes: C12N 2310/11 Antisense
• CPC Class Codes: C12N 2310/315 Phosphorothioates
• CPC Class Codes: C12N 2310/321 2'-O-R Modification
• CPC Class Codes: C12N 2310/3341 5-Methylcytosine
• CPC Class Codes: C12N 2310/341 Gapmers, i.e. of the type ===---===
• CPC Class Codes: C12N 2310/346 having a combination of backbone and sugar modifications
• CPC Class Codes: C12N 2310/3525 MOE, methoxyethoxy
• CPC Class Codes: C12N 2320/31 Combination therapy

Abstract

The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Claims

1. A composition comprising mipomersen and eicosapentaenoic acid, wherein the composition comprises at least about 80%, by weight of all fatty acids (and/or derivatives thereof) present, eicosapentaenoic acid, and no more than about 20%, by weight of all fatty acids (and/or derivatives thereof) present, docosahexaenoic acid or ester thereof.

2. The composition of claim 1, wherein the mipomersen is present in an amount less than, about equal to, or greater than an effective amount of mipomersen when administered as a monotherapy.

3. The composition of claim 1, wherein the mipomersen comprises mipomersen nonadecasodium.

4. The composition of claim 1, wherein the mipomersen is suspended in the eicosapentaenoic acid.

5. The composition of claim 1, wherein the mipomersen is in the form of an injectable solution.

6. The composition of claim 1, wherein the mipomersen is present in an amount of about 5 mg to about 2000 mg.

7. The composition of claim 1, wherein the eicosapentaenoic acid is present in an amount of about 400 mg to about 5000 mg.

8. The composition of claim 1, wherein the mipomersen is present in an amount of about 2 mg to about 10 mg and the eicosapentaenoic acid is present in an amount of about 400 mg to about 5000 mg.