Claims for Patent: 5,116,952

Summary for Patent: 5,116,952

Title:	Protein active in humoral hypercalcemia of malignancy-PTHRP
Abstract:	Substantially pure proteins active in humoral hypercalcemia of malignancy (PTHrP) and sub-units and fragments thereof. Antibody reagents capable of binding to epitopes of PTHrP. Methods and kits for the detection of PTHrP.
Inventor(s):	Martin; Thomas J. (Kew, AU), Moseley; Jane M. (North Balwyn, AU), Kemp; Bruce E. (Kew, AU), Wettenhall; Richard E. H. (Camberwell, AU)
Assignee:	The University of Melbourne (Victoria, AU)
Application Number:	07/199,235
Patent Claims:	1. Substantially pure parathyroid hormone related protein having: (a) an N-terminal amino acid sequence A V S E H Q L L H D K G K S I Q D L R R R F F L H H L I A E I H T A E I R A T S E X T X N wherein X is an unidentified amino acid; (b) a molecular weight between 15 to 25 kilodaltons, as determined by sodium dodecyl polyacrylamide gel electrophoresis under reducing and non-reducing conditions; and (c) a specific biological activity of at least about 6 mg equivalents of a peptide composed of amino acids 1 to 34 of parathyroid hormone per mg protein as measured in an adenylate cyclase response assay. 2. Substantially pure parathyroid hormone related hormone as claimed in claim 1, further having: (d) an amino acid composition as shown in Table 2; (e) an ability to activate adenylate cyclase in parathyroid hormone target cells; and (f) an ability to increase plasminogen activator activity in osteoblast-like cells, with a potency greater than that of a peptide composed of amino acids 1 to 39 of parathyroid hormone. 3. Substantially pure parathyroid hormone related hormone as claimed in claim 1, having a molecular weight between 20 and 27 kilodaltons as determined by sodium dodecyl polyacrylamide gel electrophoresis under reducing and non-reducing conditions. 4. A method for the purification of parathyroid hormone related hormone comprising the following steps: (a) culturing BEN cells in culture medium; (b) acidifying the culture medium to a pH of about 4.8 and then applying the culture medium to a cation exchange resin at a pH of about 4.8; (c) eluting fractions from the cation exchange resin, said medium and resin being maintained at a pH of abouty 4.8, and assaying said fractions for parathyroid hormone related hormone activity; and (d) performing reverse phase high pressure liquid chromatography on those fractions possessing parathyroid hormone related hormone activity and subsequently isolating substantially pure parathyroid hormone related hormone.

Details for Patent 5,116,952

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2009-05-26