Claims for Patent: 7,851,163

Summary for Patent: 7,851,163

Title:	Method for determining the biologically effective parathyroid hormone activity in a sample
Abstract:	Immunoassay for the determination of parathyroid hormone activity in a sample, and for the diagnosis, etiology and treatment of calcium metabolism disturbances, osteopathies and hyper- or hypoparathyroidisms. The parathyroid hormone activity is measured with the aid of an antibody which binds to an epitope in the region of the receptor binding structure 15 to 22 of the parathyroid hormone, and an antibody which recognizes whether the amino-terminal end 1 to 3 of the parathyroid hormone is intact. The assay permits the antagonistic characteristics of some parathyroid hormone fragments to be taken into account.
Inventor(s):	Armbruster; Franz Paul (Bensheim, DE), Missbichler; Albert (Vienna, AT), Schmidt-Gayk; Heinrich (Neustadt-Hambach, DE), Roth; Heinz-Jurgen (Ilvesheim, DE)
Assignee:	Immundiagnostik, AG (Bensheim, DE)
Application Number:	10/168,185
Patent Claims:	1. A method for determining the effective parathyroid hormone activity in a sample, comprising the steps of: (A) determining the agonist activity in a sample by reacting the sample with a first antibody which recognizes an epitope between amino acids 15 to 22 of the human parathyroid hormone (SEQ ID NO:16); reacting the sample with a second antibody which recognizes an epitope that is formed of the N-terminal amino acids 1-3 of the parathyroid hormone (SEQ ID NO:16) and contains the N-terminal amino acids; and determining the number of molecules which are recognized by the first and second antibodies; and (B) determining the antagonist activity of a sample by reacting the sample with a third antibody which binds to the parathyroid hormone sequence (SEQ ID NO:16) between amino acids 4 to 14; reacting the sample with a fourth antibody which binds to the parathyroid hormone sequence (SEQ ID NO:16) between amino acids 15 to 37; and determining the number of molecules which are recognized by the third and fourth antibodies; (C) placing the concentration of PTH molecules which are bound by the first and second antibodies, and the third and fourth antibodies, respectively, into a 1:1 relationship with one another to determine the physiologically effective parathyroid hormone activity; and (D) calculating the physiologically effective parathyroid hormone activity using the following equation: Concentration of Agonistic PTH Fragments (Step A) PTH Activity= Concentration of Antagonistic PTH Fragments (Step B). 2. The method according to claim 1, wherein the first antibody is bound to a solid phase and the second antibody carries a marker. 3. The method according to claim 1, wherein the binding of the first and second antibodies is effected in the presence of 0.05 to 0.1 weight percent of a mild detergent. 4. The method according to claim 2, wherein the binding of the first and second antibodies is effected in the presence of 0.05 to 0.1 weight percent of a mild detergent.

Details for Patent 7,851,163

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2019-12-17