Subcutaneous anti-HER2 antibody formulations and uses thereof

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United States of America Patent

PATENT NO 9345661
SERIAL NO

12804703

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Abstract

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The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. α,α-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

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Patent Owner(s)

  • GENENTECH, INC.

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Inventor(s)

Inventor Name Address # of filed Patents Total Citations
Adler, Michael Riehen, CH 53 1312
Grauschopf, Ulla Riehen, CH 15 109
Mahler, Hanns-Christian Basel, CH 64 580
Stauch, Oliver Boris Freiburg, DE 24 375

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