Claims for Patent: 7,803,770

Summary for Patent: 7,803,770

Title:	Method of treating osteoporosis comprising administration of PTHrP analog
Abstract:	The present invention provides a storage-stable composition containing a parathyroid hormone-related protein (PTHrP) and methods of using a PTHrP and the PTHrP compositions described herein to treat osteoporosis, to increase bone mass or to increase bone quality. The composition is storage stable, in sterile form, and in general may be stored at room temperature for at least several weeks to allow convenient parenteral administration to human patients.
Inventor(s):	Michael J. Dey, Nathalie Mondoly, Benedicte Rigaud, Bart Henderson, C. Richard Lyttle
Assignee:	Ipsen Pharma SAS, Radius Health Inc
Application Number:	US12/151,975
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,803,770
Patent Claims:	1. A method of treating osteoporosis comprising daily subcutaneous administration of a composition comprising 80 μg of [Glu22,25, Leu23,28,31, Aib29, Lys26,30]hPTHrP(1-34)NH2 to a human in need thereof. 2. The method of claim 1, wherein the composition further comprises an effective amount of buffer to maintain the pH between 2 and 7. 3. The method of claim 1, wherein the buffer is selected from the group consisting of acetate, tartrate, phosphate and citrate buffers. 4. The method of claim 3, wherein the buffer is an acetate buffer. 5. The method of claim 4, wherein the buffer is acetic acid and sodium acetate. 6. The method of claim 2, wherein the pH is maintained between 3 and 6. 7. The method of claim 6, wherein the pH is maintained between 4 and 6. 8. The method of claim 7, wherein the pH is maintained between 4.5 and 5.6. 9. The method of claim 1, wherein the human is a post-menopausal woman. 10. The method according to claim 9 wherein the dose is 80 μg and wherein said dose results in a plasma Cmax of [Glu22,25, Leu23,28,31, Aib29, Lys26,30]hPTHrP(1-34)NH2 from between 255.57 pg/mL and 364.3 pg/mL or from between 367.2 pg/mL and 504.8 pg/mL in said subject. 11. The method according to claim 9 wherein the dose is 80 μg and wherein said dose results in a plasma Tmax of [Glu22,25, Leu23,28,31, Aib29, Lys26,30]hPTHrP(1-34)NH2 from between 0.251 hours and 1.01 hours, or from between 0.500 hours and 1.00 hours in said subject. 12. The method according to claim 9 wherein the dose is 80 μg and wherein said dose results in a plasma t1/2 of [Glu22,25, Leu23,28,31, Aib29, LyS26,30] hPTHrP(1-34)NH2 from between 1.585 hours and 3.015 hours, or from between 1.265 hours and 2.115 hours in said subject. 13. The method according to claim 9 wherein the dose is 80 μg and wherein said dose results in a plasma Cmax of [Glu22,25, Leu23,28,31, Aib29, Lys26,30] hPTHrP(1-34)NH2 from between 255.57 pg/mL and 364.3 pg/mL and a Tmax from between 0.251 hours and 1.01 hours, or a Cmax from between 367.2 pg/mL and 504.8 pg/mL and a Tmax from between 0.500 hours and 1.00 hours in said subject. 14. The method according to claim 9 wherein the dose is 80 μg and wherein said dose results in a plasma Cmax of [Glu22,25, Leu23,28,31, Aib29, Lys26,30] hPTHrP(1-34)NH2 from between 255.57 pg/mL and 364.3 pg/mL and a Tmax from between 0.251 hours and 1.01 hours and a t1/2 of between 1.585 hours and 3.015 hours, or a Cmax from between 367.2 pg/mL and 504.8 pg/mL and a Tmax from between 0.500 hours and 1.00 hours and a t1/2 of between 1.265 hours and 2.115 hours in said subject.