Claims for Patent: 8,748,382

Summary for Patent: 8,748,382

Title:	Method of drug delivery for bone anabolic protein
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):	Dey; Michael J. (Sandbach, GB), Mondoly; Nathalie (Le Chesnay, FR), Rigaud; Benedicte (Oulins, FR), Henderson; Bart (Belmont, MA), Lyttle; C. Richard (Bala Cynwyd, PA)
Assignee:	Radius Health, Inc. (Cambridge, MA) Ipsen Pharma S.A.S. (Boulogne-Billancourt, FR)
Application Number:	13/438,086
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,748,382
Patent Claims:	1. A method of stimulating bone growth in a subject in need thereof comprising administering to said subject a storage stable composition comprising: a) a PTHrP having the sequence [Glu.sup.22,25, Leu.sup.23,28,31, Aib.sup.29, Lys.sup.26,30]hPTHrP(1-34)NH.sub.2 (SEQ ID NO.: 2); and b) an effective amount of buffer to maintain the pH in a range of about 4.5 to about 5.6. 2. The method of claim 1, wherein said subject is administered the storage stable composition by subcutaneous injection of an amount of said composition containing from about 40 to about 45 .mu.g of [Glu.sup.22,25, Leu.sup.23,28,31, Aib.sup.29, Lys.sup.26,30]hPTHrP(1-34)NH.sub.2 (SEQ ID NO.2). 3. The method of claim 2, wherein said storage-stable composition further comprises phenol in a concentration from about 0.25 to about 5 mg/mL. 4. The method of claim 3, wherein said pH buffer is an acetate buffer. 5. The method of claim 1, wherein said subject is administered the storage stable composition by subcutaneous injection of an amount of said composition containing from about 75 to about 80 .mu.g of [Glu.sup.22,25, Leu.sup.23,28,31, Aib.sup.29, Lys.sup.26,30]hPTHrP(1-34)NH.sub.2 (SEQ ID NO.2). 6. The method of claim 5, wherein said storage-stable composition further comprises phenol in a concentration from about 0.25 to about 5 mg/mL. 7. The method of claim 6, wherein said pH buffer is an acetate buffer. 8. The method of claim 1, wherein said subject has a bone fracture. 9. The method of claim 2, wherein the subcutaneous injection is once per day, once every other day, twice per week, once per week, once every two weeks or once per month. 10. The method of claim 2, wherein the subcutaneous injection is single daily subcutaneous injection. 11. The method of claim 5, wherein the subcutaneous injection is once per day, once every other day, twice per week, once per week, once every two weeks or once per month. 12. The method of claim 5, wherein the subcutaneous injection is single daily subcutaneous injection.