IP Library Patent Application 12741030
Patent Application
App. No. 12/741,030

METHOD, COMPOSITION, AND ARTICLE OF MANUFACTURE FOR PROVIDING ALPHA-1 ANTITRYPSIN

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Patent No.
US None
App. No.
12/741,030
Abstract

The present invention provides a method for providing alpha-1 antitrypsin (α1-AT) to a subject, in particular a method for treating or preventing a disorder or disease associated with α1-AT deficiency in the subject, wherein the method comprises providing, subcutaneously, a therapeutically or prophylactically effective amount of α1-AT to the subject. Also provided is a composition and article of manufacture comprising α1-AT, in particular a formulation suitable for subcutaneous administration of α1-AT.

Claims (12)

1 . A method for treating or preventing a disorder or disease associated with α1-AT deficiency in a subject, the method comprising administering, subcutaneously, a therapeutically or prophylactically effective amount of α1-AT to the subject.

2 . A method for treating or preventing a disorder or disease associated with α1-AT deficiency in a subject, the method comprising:

a) determining a therapeutically or prophylactically effective amount of α1-AT based on a dosing regimen comprising intravenously administered α1-AT; and

b) administering, subcutaneously, a dose of at least about 120% of the therapeutically or prophylactically effective amount of α1-AT to the subject.

3 . An α1-AT formulation suitable for subcutaneous administration.

4 . The formulation of claim 3 , wherein the formulation is a lyophilized formulation to be reconstituted prior to administration.

5 . A method for treating or preventing a disorder or disease associated with α1-AT deficiency in a subject, the method comprising administering, subcutaneously, a composition comprising a therapeutically or prophylactically effective amount of an α1-AT to the subject, wherein α1-AT is administered in combination with one or more reagents.

6 . The method of claim 5 , wherein the one or more reagents is a hyaluronidase.

7 . The method of claim 6 , wherein the composition is a pharmaceutical composition comprising α1-AT and a hyaluronidase, wherein the composition is suitable for subcutaneous administration to the subject.

8 . An article of manufacture comprising an α1-AT formulation for subcutaneous administration.

9 . The article of claim 8 further comprising a hyaluronidase.

10 . The article of claim 8 , wherein the formulation further comprises a hyaluronidase.

Assignments (29)
RELEASE OF SECURITY INTEREST IN PATENTS, RECORDED ON DECEMBER 10, 2021 AT REEL 058480 FRAME 0221 Recorded May 21, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC (FORMERLY KNOWN AS GRIFOLS THERAPEUTICS, INC.); GRIFOLS BIOLOGICALS LLC (FORMERLY KNOWN AS GRIFOLS BIOLOGICALS, INC.); BIOMAT USA, INC.; GRIFOLS USA, LLC; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; TALECRIS PLASMA RESOURCES, INC.
Reel/Frame 075614/0936 →
RELEASE OF SECURITY INTEREST Recorded Apr 15, 2026
From: EUROPEAN INVESTMENT BANK
To: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC (F/K/A GRIFOLS THERAPEUTICS, INC.); GRIFOLS BIOLOGICALS LLC (F/K/A GRIFOLS BIOLOGICALS, INC.); BIOMAT USA, INC.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC; TALECRIS PLASMA RESOURCES, INC.
Reel/Frame 075416/0633 →
RELEASE OF SECURITY INTEREST Recorded Apr 15, 2026
From: EUROPEAN INVESTMENT BANK
To: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC (F/K/A GRIFOLS THERAPEUTICS, INC.); GRIFOLS BIOLOGICALS LLC (F/K/A GRIFOLS BIOLOGICALS, INC.); BIOMAT USA, INC.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC; TALECRIS PLASMA RESOURCES, INC.
Reel/Frame 075416/0698 →
RELEASE OF SECURITY INTEREST Recorded Apr 15, 2026
From: EUROPEAN INVESTMENT BANK
To: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC (F/K/A GRIFOLS THERAPEUTICS, INC.); GRIFOLS BIOLOGICALS LLC (F/K/A GRIFOLS BIOLOGICALS, INC.); BIOMAT USA, INC.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC; TALECRIS PLASMA RESOURCES, INC.
Reel/Frame 075416/0718 →
RELEASE OF SECURITY INTEREST Recorded Apr 15, 2026
From: THE BANK OF NEW YORK MELLON, LONDON BRANCH
To: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC (F/K/A GRIFOLS THERAPEUTICS, INC.); GRIFOLS BIOLOGICALS LLC (F/K/A GRIFOLS BIOLOGICALS, INC.); GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC; BIOMAT USA, INC.; TALECRIS PLASMA RESOURCES, INC.
Reel/Frame 075329/0824 →
PARTIAL RELEASE OF SECURITY INTEREST Recorded Dec 10, 2021
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: BIOMAT USA, INC.; TALECRIS PLASMA RESOURCES, INC.
Reel/Frame 058480/0221 →
PARTIAL RELEASE OF SECURITY INTEREST IN PATENTS AT REEL/FRAME NO. 51024/0317 Recorded Dec 7, 2021
From: EUROPEAN INVESTMENT BANK
To: BIOMAT USA, INC.; TALECRIS PLASMA RESOURCES, INC.
Reel/Frame 058518/0524 →
PARTIAL RELEASE OF SECURITY INTEREST IN PATENTS AT REEL/FRAME NO. 51021/0593 Recorded Dec 7, 2021
From: EUROPEAN INVESTMENT BANK
To: BIOMAT USA, INC.; TALECRIS PLASMA RESOURCES, INC.
Reel/Frame 058350/0980 →
PARTIAL RELEASE OF SECURITY INTEREST IN PATENTS AT REEL/FRAME NO. 51024/0453 Recorded Dec 7, 2021
From: EUROPEAN INVESTMENT BANK
To: BIOMAT USA, INC.; TALECRIS PLASMA RESOURCES, INC.
Reel/Frame 058351/0064 →
PARTIAL RELEASE OF SECURITY INTEREST IN PATENTS AT REEL/FRAME NO. 51047/0139 Recorded Dec 1, 2021
From: THE BANK OF NEW YORK MELLON, LONDON BRANCH
To: BIOMAT USA, INC.; TALECRIS PLASMA RESOURCES, INC.
Reel/Frame 058292/0564 →
SECURITY INTEREST Recorded Nov 18, 2019
From: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC; GRIFOLS BIOLOGICALS LLC; BIOMAT USA, INC.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC; TALECRIS PLASMA RESOURCES, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 051047/0123 →
RELEASE OF SECURITY INTEREST Recorded Nov 18, 2019
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC (FORMERLY KNOWN AS GRIFOLS THERAPEUTICS, INC.); GRIFOLS BIOLOGICALS LLC (FORMERLY KNOWN AS GRIFOLS BIOLOGICALS, INC.); BIOMAT USA, INC.; GRIFOLS DIAGNOSTIC SOLUTIONS INC.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC
Reel/Frame 051047/0153 →
SECURITY INTEREST Recorded Nov 18, 2019
From: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC; GRIFOLS BIOLOGICALS LLC; BIOMAT USA, INC.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC; TALECRIS PLASMA RESOURCES, INC.
To: THE BANK OF NEW YORK MELLON, LONDON BRANCH, AS NOTES COLLATERAL AGENT
Reel/Frame 051047/0139 →
RELEASE OF SECURITY INTEREST Recorded Nov 15, 2019
From: EUROPEAN INVESTMENT BANK
To: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC (FORMERLY KNOWN AS GRIFOLS THERAPEUTICS, INC.; GRIFOLS BIOLOGICALS LLC (FORMERLY KNOWN AS GRIFOLS BIOLOGICALS, INC.); BIOMAT USA, INC.; GRIFOLS DIAGNOSTIC SOLUTIONS INC.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC
Reel/Frame 051064/0021 →
SECURITY INTEREST Recorded Nov 15, 2019
From: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC; GRIFOLS BIOLOGICALS LLC; BIOMAT USA, INC.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC; TALECRIS PLASMA RESOURCES, INC.
To: EUROPEAN INVESTMENT BANK
Reel/Frame 051021/0593 →
SECURITY INTEREST Recorded Nov 15, 2019
From: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC; GRIFOLS BIOLOGICALS LLC; BIOMAT USA, INC.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC; TALECRIS PLASMA RESOURCES, INC.
To: EUROPEAN INVESTMENT BANK
Reel/Frame 051024/0317 →
SECURITY INTEREST Recorded Nov 15, 2019
From: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC; GRIFOLS BIOLOGICALS LLC; BIOMAT USA, INC.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC; TALECRIS PLASMA RESOURCES, INC.
To: EUROPEAN INVESTMENT BANK
Reel/Frame 051024/0453 →
RELEASE OF SECURITY INTEREST Recorded Nov 15, 2019
From: EUROPEAN INVESTMENT BANK
To: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC (FORMERLY KNOWN AS GRIFOLS THERAPEUTICS, INC.); GRIFOLS BIOLOGICALS LLC (FORMERLY KNOWN AS GRIFOLS BIOLOGICALS, INC.); BIOMAT USA, INC.; GRIFOLS DIAGNOSTIC SOLUTIONS INC.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.
Reel/Frame 051024/0722 →
SECURITY INTEREST Recorded Sep 7, 2018
From: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS LLC; GRIFOLS BIOLOGICALS LLC; BIOMAT USA, INC.; GRIFOLS DIAGNOSTIC SOLUTIONS INC.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC
To: EUROPEAN INVESTMENT BANK, AS LENDER
Reel/Frame 047438/0836 →
CHANGE OF ADDRESS Recorded Jun 1, 2018
From: GRIFOLS THERAPEUTICS LLC
To: GRIFOLS THERAPEUTICS LLC
Reel/Frame 046286/0824 →
CHANGE OF NAME Recorded Jan 5, 2018
From: GRIFOLS THERAPEUTICS INC.
To: GRIFOLS THERAPEUTICS LLC
Reel/Frame 045008/0573 →
SECURITY INTEREST Recorded Dec 5, 2017
From: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS INC.; GRIFOLS BIOLOGICALS INC.; BIOMAT USA, INC.; GRIFOLS DIAGNOSTIC SOLUTIONS.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.
To: EUROPEAN INVESTMENT BANK, AS LENDER
Reel/Frame 044696/0846 →
SECURITY INTEREST Recorded Dec 5, 2017
From: GRIFOLS SHARED SERVICES NORTH AMERICA, INC.; GRIFOLS THERAPEUTICS INC.; GRIFOLS BIOLOGICALS INC.; BIOMAT USA, INC.; GRIFOLS DIAGNOSTIC SOLUTIONS.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC
To: EUROPEAN INVESTMENT BANK, AS LENDER
Reel/Frame 044697/0725 →
SECURITY INTEREST Recorded Feb 7, 2017
From: GRIFOLS SHARED SERVICES NORTH AMERICA INC.; GRIFOLS THERAPEUTICS INC.; GRIFOLS BIOLOGICALS INC.; BIOMAT USA, INC.; GRIFOLS DIAGNOSTIC SOLUTIONS INC.; GRIFOLS WORLDWIDE OPERATIONS USA, INC.; GRIFOLS USA, LLC
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 041651/0487 →
RELEASE OF SECURITY INTEREST Recorded Feb 6, 2017
From: DEUTSCHE BANK AG NEW YORK BRANK
To: GRIFOLS THERAPEUTICS INC.; GRIFOLS SHARED SERVICES NORTH AMERICA INC.; GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Reel/Frame 041638/0527 →
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 26390/0193 Recorded Jan 25, 2017
From: DEUTSCHE BANK AG NEW YORK BRANCH
To: GRIFOLS, S.A.; GRIFOLS INC.; TALECRIS BIOTHERAPEUTICS, INC.
Reel/Frame 041494/0017 →
SECURITY AGREEMENT Recorded Feb 27, 2014
From: GRIFOLS INC.; GRIFOLS THERAPEUTICS INC.; GRIFOLS-CHIRON DIAGNOSTICS CORP.
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 032367/0001 →
CHANGE OF NAME Recorded Jun 18, 2013
From: TALECRIS BIOTHERAPEUTICS, INC.
To: GRIFOLS THERAPEUTICS INC.
Reel/Frame 030650/0819 →
SECURITY AGREEMENT Recorded Jun 3, 2011
From: GRIFOLS, S.A.; GRIFOLS INC.; TALECRIS BIOTHERAPEUTICS, INC.
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 026390/0193 →