IP Library Granted Patent US 10,434,059
Granted Patent B2
US 10,434,059 · App. 15/680,819 · Granted Oct 8, 2019

Medicament for the treatment of viral skin and tumour diseases

Inventors: Yunik Chang (Clermont, FL); Robert Lathrop (Fort Collins, CO); Erwin Böhm (Ladenburg, DE); Irene Gander-Meisterernst (Münster, DE); Regina Greger (Iffeldorf, DE); Johanna Holldack (Berlin, DE); Ulrich Moebius (Gauting-Unterbrunn, DE)
Assignee: Fougera Pharmaceuticals Inc.
A61K9/0014A61K31/23A61K31/353A61K47/06A61K47/10A61K47/14Y10S514/934Y10S514/947Y10S514/967Y10S514/969
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Quick Facts
Patent No.
US 10,434,059
App. No.
15/680,819
Granted
Oct 8, 2019
Kind
B2
Abstract

The invention relates to a medicament containing a compound of general formula (I), where R 1 =independently, a straight or branched, saturated, singly- or multiply-unsaturated, optionally substituted C 11 -C 21 alkyl, alkylene or alkinyl group, preferably a C 11 -C 15 alkyl, alkylene or alkinyl group, particularly a C 11 -C 13 alkyl, alkylene or alkinyl group, most preferably a C 13 alkyl group, R 2 =independently, a straight or branched C 1 -C 8 alkyl, alkylene or alkinyl group, preferably a C 1 -C 6 alkyl, alkylene or alkinyl group, in particular a C 2 -C 4 alkyl, alkylene or alkinyl group, most preferably a C 3 alkyl group, a —[CH 2 —(CH 2 )m-O] n H group with n=1 to 10, preferably n=1 to 5, to m=1 to 5, preferably m=1 to 3, a —CH 2 —[CH—(OH)] p [CH 2 —R 3 ]— group, where R 3 =independently H or OH, p=1 to 7, preferably p=1 to 4, a pentose group or a hexose group, as therapeutically active agent, alone or in combination with one or several further pharmaceutical agents as a combination preparation for the treatment of viral skin diseases and/or tumor diseases, in particular caused by human papilloma virus (HPV) and/or herpes viruses and a topically acting medicament formulation and the use thereof.

Claims (29)

1. A pharmaceutical composition comprising isopropyl myristate,

and a mixture of catechols comprising 4-15% (w/w) of (−)-epicatechol, 2-20% (w/w) of (−)-epicatechol gallate, 3-15% (w/w) of (−)-epigallocatechol, 40-75% (w/w) of (−)-epigallocatechol gallate, 0.1-1% (w/w) of (−)-gallocatechol, and 1-10% (w/w) of (−)-gallocatechol gallate; and

wherein the pharmaceutical comprises at least 5-50% (w/w) of isopropyl myristate.

2. The pharmaceutical composition of claim 1 , wherein said pharmaceutical composition comprises 1-30% (w/w) of said mixture of catechols and at least 10-50% (w/w) of isopropyl myristate.

3. The pharmaceutical composition of claim 2 , wherein said pharmaceutical composition comprises 2-20% (w/w) of said mixture of catechols.

4. The pharmaceutical composition of claim 3 , wherein said pharmaceutical composition comprises 15-18% (w/w) of said mixture of catechols.

5. The pharmaceutical composition of claim 2 , wherein said pharmaceutical composition comprises at least 25-50% (w/w) of isopropyl myristate.

6. The pharmaceutical composition of claim 5 , wherein said pharmaceutical composition comprises at least 35-50% (w/w) of isopropyl myristate.

7. The pharmaceutical composition of claim 1 , wherein said mixture of catechols comprises 5-7% (w/w) of said (−)-epicatechol gallate.

8. The pharmaceutical composition of claim 1 , wherein said mixture of catechols comprises 0.1-0.6% (w/w) of said (−)-gallocatechol.

9. The pharmaceutical composition of claim 1 , wherein said mixture of catechols comprises 1-5% (w/w) of said (−)-gallocatechol gallate.

10. The pharmaceutical composition of claim 1 , wherein said mixture of catechols comprises 10.8% (w/w) of (−)-epicatechol, 6.5% (w/w) of (−)-epicatechol gallate, 9.2% (w/w) of (−)-epigallocatechol, 54.8% (w/w) of (−)-epigallocatechol gallate, and/or 4.0% (w/w) of (−)-gallocatechol gallate.

11. The pharmaceutical composition of claim 1 , wherein said pharmaceutical composition comprises at least 10-50% (w/w) of isopropyl myristate.

12. The pharmaceutical composition of claim 11 , wherein said pharmaceutical composition comprises at least 25-50% (w/w) of isopropyl myristate.

13. The pharmaceutical composition of claim 12 , wherein said pharmaceutical composition comprises at least 35-50% (w/w) of isopropyl myristate.

14. The pharmaceutical composition of claim 1 , wherein said catechols are isolated from a tea extract.

15. The pharmaceutical composition of claim 1 , wherein one or more additional pharmaceutical compound(s) is/are administered simultaneously or separately.

16. The pharmaceutical composition of claim 15 , wherein said one or more additional pharmaceutical compound(s) is/are amphiphilic.

17. The pharmaceutical composition of claim 1 , further comprising additives and/or auxiliary substances.

18. The pharmaceutical composition of claim 17 , wherein said additives and/or auxiliary substances are hydrophobic and are selected from the group consisting of petroleum jelly, wax, oleyl alcohol, propylene glycol monostearate, and propylene glycol monopalmitostearate.

19. A pharmaceutical composition comprising 35% (w/w) of isopropyl myristate,

15% (w/w) of a mixture of catechols comprising 4-15% (w/w) of (−)-epicatechol, 2-20% (w/w) of (−)-epicatechol gallate, 3-15% (w/w) of (−)-epigallocatechol, 40-75% (w/w) of (−)-epigallocatechol gallate, 0.1-1% (w/w) of (−)-gallocatechol, 1-10% (w/w) of (−)-gallocatechol gallate, 24.5% (w/w) of petroleum jelly, 20% (w/w) of wax, 5% (w/w) of propylene glycol monostearate or propylene glycol monopalmitostearate, and 0.5% (w/w) of oleyl alcohol.

20. A method of treating a papilloma virus-induced skin disease or benign tumor disease in a patient, said method comprising administering to a patient a pharmaceutical composition of claim 19 .

21. The method of claim 20 , wherein said papilloma virus-induced skin disease or benign tumor disease is caused by HPV 1, 2, 3, 4, 5, 6, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19-29, 31, 32, 34, 36-38, 46-50, 56, or 58.

22. The method of claim 20 , wherein said papilloma virus-induced skin diseases are warts or genital warts and the papilloma virus-induced benign tumors are of the skin and/or mucosa.

23. The method of claim 22 , wherein said papilloma virus-induced benign tumors of the skin and/or mucosa are verrucae plantares, verrucae vulgares, verrucae planae juveniles, epidermodysplasia verruciformis, Condylomata acuminata, Condylomata plana , bowenoid papulosis, papillomas on the larynx and oral mucosa, or focal epithelial hyperplasia.

24. The method of claim 20 , wherein said pharmaceutical composition is applied topically.

25. The method of claim 24 , wherein said pharmaceutical composition is applied genitally or vaginally.

26. A pharmaceutical composition comprising 35% (w/w) of isopropyl myristate, 15% (w/w) of a mixture of catechols comprising 4-15% (w/w) of (−)-epicatechol, 2-20% (w/w) of (−)-epicatechol gallate, 3-15% (w/w) of (−)-epigallocatechol, 40-75% (w/w) of (−)-epigallocatechol gallate, 0.1-1% (w/w) of (−)-gallocatechol, 1-10% (w/w) of (−)-gallocatechol gallate, 35% (w/w) of white petrolatum, 25% (w/w) of white wax, 5% (w/w) of propylene glycol monopalmitostearate, and 0.5% (w/w) of oleyl alcohol.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 5, 2024
From: FOUGERA PHARMACEUTICALS INC.
To: ANI PHARMACEUTICALS, INC.
Reel/Frame 068186/0525 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 11, 2018
From: MEDIGENE AG
To: FOUGERA PHARMACEUTICALS INC
Reel/Frame 044603/0099 →
Priority Claims (1)
DE 10156794 · Nov 19, 2001 · national
Continuity (4)
Continuation 12887250 · Sep 21, 2010
Continuation 10495889
Provisional Application 60331705 · Nov 19, 2001
Related Publication 20180193254A1 · Jul 12, 2018