# US 2013/0158089 A1 · MANUFACTURE, COMPOSITIONS AND USES OF COAGULATION FACTOR VIIa MODULATOR

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- Number: US 2013/0158089 A1
- Document ID: US20130158089A1
- Status: Published application
- Kind: A1
- Application number: 13/668,167
- Filed: 2012-11-02
- Published: 2013-06-20
- Earliest claimed: 2007-10-16
- Assignees: Pharmacyclics, Inc.
- Inventors: David Loury; Tarak Mody
- Web page: https://patentgrep.com/patent/US20130158089A1

## CPC

- A61K 31/4184: condensed with carbocyclic rings, e.g. benzimidazoles
- A61K 31/4164: 1,3-Diazoles
- A61K 41/00: Medicinal preparations obtained by treating materials with wave energy or particle radiation {; Therapies using these preparations}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 7/02: Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 35/04: specific for metastasis
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07D 209/00: Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
- C07D 235/12: Radicals substituted by oxygen atoms
- C07D 235/18: with aryl radicals directly attached in position 2
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08)

## Abstract

Treatment of cancer and thromboembolic disorders using inhibitors of Factor VIIa are disclosed herein using a compound of Formula I:

## Claims

### Claim at position 1

-176. (canceled)

### Claim 177

A composition comprising:
a) a compound of Formula I or a salt thereof:
and
b) a thrombin modulator.

### Claim 178

A composition comprising: a compound of Formula I or a salt thereof:
wherein the composition is stable with respect to compound degradation for at least about 1 month.

### Claim 179

A composition comprising:
a) a compound of Formula I or a salt thereof:
and
b) an amino acid buffer.

### Claim 180

A combined dosage comprising:
a) a compound of Formula I or a salt thereof:
and
b) an additional therapeutic agent.

### Claim 181

A composition comprising: a compound of Formula I or a salt thereof:
wherein the pH of the composition is between 7 and 9.

### Claim 182

A composition comprising:
a) a compound of Formula I or a salt thereof:
and
b) a divalent cation.

### Claim 183

A composition comprising: a compound of Formula I or a salt thereof:
wherein the composition is formulated for administration by IV bolus or IV infusion.

### Claim 184

A composition comprising: a compound of Formula I or a salt thereof:
wherein the osmolality of the composition is from about 280 mOsm/kg to about 320 mOsm/kg.

### Claim 185

A kit comprising,
a) a container comprising:
i. a compound of Formula I or a salt thereof:
and
ii. an additional therapeutic agent; and
iii. a buffer and/or diluent; and
b) a set of instructions.

### Claim 186

A composition comprising: a compound of Formula I or a salt thereof:
wherein the composition is isotonic.