Neurocrine Biosciences, Inc.

Ambit Biosciences Corporation

Patrick B O'Donnell

William Jay Thiele

Joyce K James

Robert E Corringham

Timothy David Gross

Provided herein are methods of administering N-(5-tert-butyl-isoxazol-3-yl)-N'-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea, or a pharmaceutically acceptable salt or solvate thereof, to human patients, including a specific patient population. Specifically, dosing, dosing schedules or dosing regimens are provided herein. Methods of treating proliferative diseases or FLT-3 mediated diseases in humans are also provided.

Methods of treating proliferative diseases

Provided herein are hydrobromide salts of a pyrazolylaminoquinazoline, and pharmaceutical compositions thereof. Also provided are methods of their use for treating, preventing, or ameliorating a proliferative disease.

Hydrobromide salts of a pyrazolylaminoquinazoline

Polymorphs of N-methyl-N-(3-{3-[2-thienylcarbonyl]-pyrazol-[1,5-&#x3b1;]-pyrimidin-7-yl}phenyl)acetamide (Compound 1), and use of the same as a sedative-hypnotic, anxiolytic, anticonvulsant, and skeletal muscle relaxant agent. Processes for making the same, as well as related compositions and methods are also disclosed, particularly with regard to treatment of insomnia. A polymorph Form I possessing exception physical and heat stability is provided. A polymorph Form II:

Polymorphs of N-methyl-N-(3-{3-[2-thienylcarbonyl]-pyrazol-[1,5-&#x3b1;]-pyrimidin-7-yl}phenyl)acetamide and compositions and methods related thereto

Polymorphs of N-methyl-N-(3-&lcub;3-&lsqb;2-thienylcarbonyl&rsqb;-pyrazol-&lsqb;1,5-&agr;&rsqb;-pyrimidin-7-yl&rcub;phenyl)acetamide (Compound 1), and use of the same as a sedative-hypnotic, anxiolytic, anticonvulsant, and skeletal muscle relaxant agent. Processes for making the same, as well as related compositions and methods are also disclosed, particularly with regard to treatment of insomnia. A polymorph Form I possessing exception physical and heat stability is provided. A polymorph Form II

Polymorphs of N-methyl-N-(3-&lcub;3-&lsqb;2- thienylcarbonyl&rsqb;-pyrazol-&lsqb;1,5-&agr;&rsqb;- pyrimidin-9-yl&rcub;phenyl)acetamide and compositions and methods related thereto

Polymorphs of N-methyl-N-(3-&lcub;3-&lsqb;2-thienylcarbonyl&rsqb;-pyrazol-&lsqb;1,5-&agr;&rsqb;-pyrimidin-7-yl&rcub;phenyl)acetamide and compositions and methods related thereto

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San Diego, CA, United States of America

Patrick B O'Donnell