Claims for Patent: 9,657,087

Summary for Patent: 9,657,087

Title:	Subcutaneous administration of anti-hepatitis B antibodies
Abstract:	The present application relates to an immunoglobulin preparation comprising anti-hepatitis B antibodies for subcutaneous administration and to uses thereof, including methods for treating, preventing and/or reducing a disease, disorder or condition associated with hepatitis B virus.
Inventor(s):	Laub; Orgad (Tel-Aviv, IL), Orr; Nadav (Mazkeret Batia, IL)
Assignee:	Omrix Biopharmaceuticals Ltd. (Rehovot, IL)
Application Number:	14/306,453
Patent Claims:	1. A pharmaceutical composition free of infective viral particles for subcutaneous injection in an anatomic site selected from the group consisting of arm, abdomen, and front of the thigh, comprising: a pool of anti-hepatitis B immunoglobulins prepared from a population of human donors; and an effective amount of an excipient that ensures the pool of anti-hepatitis B immunoglobulins retains chemical stability and biological activity upon storage, wherein: the pharmaceutical composition is in the form of a lyophilized powder; the excipient is selected from the group consisting of maltose, sucrose, D-sorbitol, glycine, PEG, and albumin; the pool of anti-hepatitis B immunoglobulins is at a dose that is higher than 2170 IU and is at least 2-fold higher than a dose of anti-hepatitis B immunoglobulins for administration by intramuscular injection; at least 90% of the proteins in the composition are human immunoglobulin G; when redissolved as a liquid composition, the liquid composition has a volume of equal or less than about 4.5 ml; and the dose of anti-hepatitis B immunoglobulins formulated for subcutaneous injection in an anatomic site selected from the group consisting of arm, abdomen, and front of the thigh is suitable for rapidly achieving a circulation level higher than 100 mIU/ml. 2. The pharmaceutical composition of claim 1 which is for subcutaneous administration to orthotopic liver transplantation (OLT) patients. 3. A vial or a pre-filled syringe containing the pharmaceutical composition of claim 1.

Details for Patent 9,657,087

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Ag	CARIMUNE, CARIMUNE NF, PANGLOBULIN, SANDOGLOBULIN	immune globulin intravenous (human)	For Injection	102367	07/27/2000		2028-12-04
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	07/26/2007		2028-12-04
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10/02/2009		2028-12-04
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	02/07/2013		2028-12-04
Bio Products Laboratory	GAMMAPLEX	immune globulin intravenous (human)	Injection	125329	09/17/2009		2028-12-04