Amgen Inc.

Bristol-myers Squibb Compnay

Seshadri Neervannan

Karnail S Atwal

Anuradha V Gore

Pengzu Zhou

Roger Zanon

Nina Cauchon

Gonzalo Alva

Joyce Chou

Anne Navratil

Christopher W Spancake

Belle B Liu

The present invention relates to injectable formulations of irritant agents, such as calcimimetics, that are pharmaceutically stable and demonstrate a reduced incidence of irritation, pain, phlebitis, precipitation and hemolysis upon injection.

Stable emulsion formulations

The anti-angiogenic drug AMG 706 is provided in the mono-phosphate hydrate form. Also provided is AMG 706 drug substance wherein the AMG 706 is present, in at least a detectable amount, as AMG 706 phosphate dihydrate. Also provided are processes for preparing AMG 706 phosphate dihydrate, AMG 706 drug substance of the invention, and a pharmaceutical composition of the invention. Also provided is a method of treating a medical condition or disorder in a subject where treatment with an anti-angiogenic is indicated, comprising administering, for example orally, a composition of the invention in a therapeutically effective amount.

Hydrate forms of AMG706

The (R)-enantiomer of 4-&lsqb;&lsqb;(cyanoimino)-&lsqb;(1,2,2-trimethylpropyl)amino&rsqb;methyl&rsqb;amino&rsqb;-benzonitrile as well as the corresponding (S)-enantiomer are useful for promoting hair growth such as in male pattern baldness.

Enantiomers of 4-&lsqb;&lsqb;(cyanoimino) &lsqb;(1,2,2-trimethylpropyl)amino&rsqb;methyl&rsqb;amino&rsqb;benzonitrile

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Irvine, CA, United States of America

Seshadri Neervannan