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Generated: July 25, 2017

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Title:Dalbavancin compositions for treatment of bacterial infections
Abstract: The invention provides methods and compositions for treatment of bacterial infections. Methods of the invention include administration of dalbavancin formulations for treatment of a bacterial infection, in particular a Gram-positive bacterial infection of skin and soft tissue. Dosing regimes include once weekly administration of dalbavancin, which often remains at therapeutic levels in the bloodstream for at least one week, providing prolonged therapeutic action against a bacterial infection.
Inventor(s): Stogniew; Martin (Blue Bell, PA)
Assignee: Vicuron Pharmaceuticals, Inc. (King of Prussia, PA)
Application Number:10/834,395
Patent Claims: 1. A dry formulation comprising: dalbavancin; at least one stabilizer that is a sugar; wherein the formulation has a pH of about 4 5; wherein the formulation contains no more than about 5% MAG by weight after about three months at 40.degree. C.

2. The formulation of claim 1, wherein the sugar is selected from mannitol, lactose, sucrose, sorbitol, glycerol, cellulose, trehalose, maltose, or dextrose.

3. The formulation of claim 1, wherein the ratio of dalbavancin to stabilizer is about 2:1 by weight.

4. The formulation of claim 1, wherein formulation is freeze-dried.

5. The formulation of claim 1, wherein the sugar comprises lactose or mannitol.

6. The formulation of claim 1, wherein the sugar comprises lactose or mannitol and the ratio of dalbavancin to stabilizer is about 2:1 by weight.

7. The formulation of claim 1, wherein the sugar comprises mannitol or lactose, and further comprising a second stabilizer comprising a second sugar.

8. The formulation of claim 1, wherein the sugar comprises mannitol, and further comprising a second stabilizer comprising lactose.

9. The formulation of claim 1, wherein the sugar comprises mannitol, and further comprising a second stabilizer comprising lactose, and wherein the ratio of dalbavancin to mannitol to lactose is about 4:1:1 by weight.

10. A dry formulation comprising: dalbavancin; a stabilizer comprising lactose and mannitol; wherein the formulation pH is about 4.5; wherein the formulation contains no more than about 4% MAG by weight after about three months at 40.degree. C.; and wherein the formulation is freeze-dried.
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Federal Trade Commission
Daiichi Sankyo
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US Department of Justice

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