Claims for Patent: 9,284,556

Summary for Patent: 9,284,556

Title:	Methods for the treatment of hepatitis B and hepatitis D infections
Abstract:	It is disclosed a method for the treatment of hepatitis B (HBV) infection or HBV/hepatitis D (HDV) co-infection, the method comprising administering to a subject in need of treatment a first pharmaceutically acceptable agent that removes the hepatitis B surface antigen from the blood and a second pharmaceutically acceptable agent which stimulates immune function.
Inventor(s):	Bazinet; Michel (Montreal, CA), Vaillant; Andrew (Roxboro, CA)
Assignee:
Application Number:	14/449,174
Patent Claims:	1. A method for the treatment of hepatitis B infection or hepatitis B/hepatitis D co-infection, the method comprising administering to a patient in need of such treatment an antisense oligonucleotide that targets mRNA of the HBV genome encoding the hepatitis B surface antigen (HBsAg) and catalyzes degradation of that mRNA, and at least one pharmaceutically acceptable agent selected from the group consisting of: thymosin .alpha.1; interferon .beta.-1a; interferon .beta.-1b; interferon .gamma.-1b; interferon .lamda.1; interferon .lamda.2; interferon .lamda.3; pegylated interferon .lamda.1; pegylated interferon .lamda.2; GS-9620 (4-amino-2-butoxy-8-[[3-(pyrrolidin-1-ylmethyl)phenyl]methyl]-5,7- -dihydropteridin-6-one); dehydroepiandrosterone; androstenediol; and androstenetriol. 2. A method for the treatment of hepatitis B infection or hepatitis B/hepatitis D co-infection, the method comprising administering to a patient in need of such treatment an antisense chelate complex formulation comprising an antisense oligonucleotide catalyzing the degradation of a mRNA used to produce the hepatitis B surface antigen (HBsAg) protein and at least one pharmaceutically acceptable agent selected from the group consisting of: thymosin .alpha.1; interferon .alpha.-2a; interferon .alpha.-2b; interferon .alpha.-N3; interferon .beta.-1a; interferon .beta.-1b; interferon .gamma.-1b; interferon .lamda.1; interferon .lamda.2; interferon .lamda.3; pegylated interferon .alpha.-2a; pegylated interferon .alpha.-2b; pegylated interferon .lamda.1; pegylated interferon .lamda.2; GS-9620 (4-amino-2-butoxy-8-[[3-(pyrrolidin-1-ylmethyl)phenyl]methyl]-5,7-dihydro- pteridin-6-one); dehydroepiandrosterone; androstenediol; and androstenetriol. 3. The method of claim 1 or 2, which further comprises administering at least one second pharmaceutically acceptable agent selected from the group consisting of: tenofovir disoproxil fumarate; entecavir; telbuvidine; adefovir dipivoxil; and lamivudine. 4. A method for the treatment of hepatitis B infection or hepatitis B/hepatitis D co-infection, the method comprising administering to a patient in need of such treatment an antisense oligonucleotide that targets mRNA of the HBV genome encoding the hepatitis B surface antigen (HBsAg) and catalyzes degradation of that mRNA, and at least one pharmaceutically acceptable agent selected from the group consisting of: thymosin .alpha.1; interferon .alpha.-2a; interferon .alpha.-2b; interferon .alpha.-N3; interferon .beta.-1a; interferon .beta.-1b; interferon .gamma.-1b; interferon .lamda.1; interferon .lamda.2; interferon .lamda.3; pegylated interferon .alpha.-2a; pegylated interferon .alpha.-2b; pegylated interferon .lamda.1; pegylated interferon .lamda.2; GS-9620 (4-amino-2-butoxy-8-[[3-(pyrrolidin-1-ylmethyl)phenyl]methyl]-5,7-dihydro- pteridin-6-one); dehydroepiandrosterone; androstenediol; and androstenetriol, and at least one second pharmaceutically acceptable agent selected from the group consisting of: tenofovir disoproxil fumarate; entecavir; telbuvidine; adefovir dipivoxil; and lamivudine. 5. The method of any one of claims 1, 2 and 4, wherein said antisense oligonucleotide and said pharmaceutically acceptable agent are formulated within the same pharmaceutical composition. 6. The method of any one of claims 1, 2 and 4, where said antisense oligonucleotide and said pharmaceutically acceptable agent are formulated within separate pharmaceutical compositions. 7. The method of any one of claims 1, 2 and 4, wherein said antisense oligonucleotide and said pharmaceutically acceptable agent are administered simultaneously. 8. The method of any one of claims 1, 2 and 4, wherein said antisense oligonucleotide and said pharmaceutically acceptable agent are administered by a different route of administration. 9. The method of any one of claims 1, 2 and 4, wherein said antisense oligonucleotide and said pharmaceutically acceptable agent are administered using one or more of the following: oral ingestion, aerosol inhalation, subcutaneous injection, intramuscular injection, intravenous injection and intravenous infusion.

Details for Patent 9,284,556

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471	July 23, 1993		2034-08-01
Biogen Inc.	AVONEX	interferon beta-1a	For Injection	103628	May 17, 1996		2034-08-01
Biogen Inc.	AVONEX	interferon beta-1a	Injection	103628	May 28, 2003		2034-08-01
Biogen Inc.	AVONEX	interferon beta-1a	Injection	103628	February 27, 2012		2034-08-01
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780	March 07, 2002		2034-08-01
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780	December 17, 2004		2034-08-01
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780	December 21, 2012		2034-08-01