IP Library Granted Patent US 8,148,333
Granted Patent B2
US 8,148,333 · App. 12/311,418 · Granted Apr 3, 2012

Stable composition comprising a PTHrP analogue

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Quick Facts
Patent No.
US 8,148,333
App. No.
12/311,418
Granted
Apr 3, 2012
Kind
B2
Abstract

The present invention provides a storage-stable composition containing a parathyroid hormone-related protein (PTHrP) analogue and methods of using a PTHrP analogue 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.

Claims (15)

1. A storage-stable composition suitable for administration to a subject comprising:

a) a PTHrP analogue having the sequence [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ] hPTHrP(1-34)NH 2 (SEQ ID NO.2); and

b) an effective amount of a pH buffer to maintain the pH in a range of about 4.5 to about 5.6.

2. The storage-stable composition according to claim 1 , wherein said pH is about 5.1.

3. The storage stable composition according to claim 1 , wherein said pH buffer is selected from the group consisting of acetate, tartrate, phosphate and citrate buffers.

4. The storage-stable composition according to claim 3 , wherein said pH buffer is an acetate buffer.

5. The storage-stable composition according to claim 4 , wherein said acetate buffer is acetic acid and sodium acetate.

6. The storage-stable composition according to claim 5 , wherein said buffer is present in a concentration range of about 1 mM to about 10 mM.

7. The storage stable composition according to claim 6 wherein said buffer is present in a concentration of about 6 mM.

8. The storage-stable composition according to claim 1 , further comprising an effective amount of an anti-microbial agent.

9. The storage-stable composition according to claim 8 , wherein said anti-microbial agent is phenol.

10. The storage-stable composition according to claim 9 , wherein said phenol is present in a concentration from about 0.25 to about 5 mg/mL.

11. The storage-stable composition according to claim 10 , wherein said phenol is present in a concentration of about 5 mg/mL.

12. The storage-stable composition according to claim 1 , wherein said PTHrP analogue is present in a concentration of about 2 mg/mL.

13. The storage-stable composition according to claim 1 , wherein said composition does not contain a chemical stabilizer.

Assignments (13)
PATENT SECURITY AGREEMENT Recorded Mar 16, 2026
From: RADIUS HEALTH, INC.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
Reel/Frame 075104/0121 →
RELEASE OF SECURITY INTEREST Recorded Oct 30, 2025
From: WILMINGTON TRUST, NATIONAL ASSOCIATION
To: RADIUS HEALTH, INC.
Reel/Frame 073278/0396 →
REQUEST FOR ASSIGNEE ADDRESS UPDATE Recorded Oct 14, 2025
From: IPSEN PHARMA S.A.S.
To: IPSEN PHARMA S.A.S.
Reel/Frame 073076/0992 →
SECURITY INTEREST Recorded Aug 16, 2022
From: RADIUS HEALTH, INC.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 061179/0001 →
RELEASE OF SECURITY INTEREST Recorded Aug 15, 2022
From: MIDCAP FUNDING IV TRUST
To: RADIUS HEALTH, INC.; RADIUS PHARMACEUTICALS, INC.
Reel/Frame 061176/0914 →
RELEASE OF SECURITY INTEREST Recorded Aug 15, 2022
From: MIDCAP FINANCIAL TRUST
To: RADIUS HEALTH, INC.; RADIUS PHARMACEUTICALS, INC.
Reel/Frame 061176/0938 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 20, 2021
From: DONG, ZHENGXIN
To: IPSEN PHARMA S.A.S.
Reel/Frame 057238/0433 →
REAFFIRMATION, JOINDER & AMENDMENT TO SECURITY AGREEMENT (REVOLVING) Recorded Mar 17, 2021
From: RADIUS HEALTH, INC.; RADIUS PHARMACEUTICALS, INC.; RADIUS HEALTH VENTURES, INC.
To: MIDCAP FUNDING IV TRUST, AS AGENT
Reel/Frame 055632/0316 →
REAFFIRMATION, JOINDER & AMENDMENT TO SECURITY AGREEMENT (TERM) Recorded Mar 17, 2021
From: RADIUS HEALTH, INC.; RADIUS PHARMACEUTICALS, INC.; RADIUS HEALTH VENTURES, INC.
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 055632/0017 →
ASSIGNMENT OF INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jul 6, 2020
From: MIDCAP FINANCIAL TRUST
To: MIDCAP FUNDING IV TRUST
Reel/Frame 053131/0465 →
SECURITY INTEREST (TERM) Recorded Jan 15, 2020
From: RADIUS HEALTH, INC.; RADIUS PHARMACEUTICALS, INC.
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 051618/0200 →
SECURITY INTEREST (REVOLVING) Recorded Jan 15, 2020
From: RADIUS HEALTH, INC.; RADIUS PHARMACEUTICALS, INC.
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 051618/0758 →
CHANGE OF NAME Recorded Jun 15, 2009
From: SOCIETE DE CONSEILS DE RECHERCHES ET D'APPLICATIONS SCIENTIFIQUES
To: IPSEN PHARMA S.A.S.
Reel/Frame 022826/0976 →