Pharmaceutical composition comprising a benzodiazepine derivative and an inhibitor of the RSV fusion protein

1. A pharmaceutical composition which comprises a pharmaceutically acceptable carrier or diluent and:

(a) an inhibitor of the RSV fusion protein; and

(b) a benzodiazepine derivative capable of inhibiting RSV replication wherein component (a) is a compound of formula (I):

or a pharmaceutically acceptable salt thereof, wherein:

X is a direct link;

Y is;

Z is CR 6 R′, where R 6 is H, or straight, branched or cyclic C 1-6 alkyl and R′ is straight, branched or cyclic C 1-6 alkyl;

R 1 is H, CONR 4 R 5 , CO 2 R 4 or C 1-6 alkyl, said C 1-6 alkyl can be optionally substituted with OR 4 or NR 8 R 9 ;

R 4 and R 5 are H or C 1-6 alkyl;

R 8 and R 9 are each independently H, C 1-6 alkyl, SO 2 R 5 , CO 2 R 4 or COR 4 ;

R 2 is selected from the group consisting of H, NH 2 , CONR 6 R′, heteroaryl, C 2-6 alkenyl, CO 2 R 4 , N═CPh 2 , C(═NH)NH 2 and C 1-6 alkyl; said alkyl optionally substituted with a member selected from the group consisting of halogen, CN, NR 10 R 11 , OSO 2 R 4 and OR 4 ;

R 10 and R 11 are each independently selected from the group consisting of H, C 1-6 alkyl, C 3-6 cycloalkyl, CO 2 R 4 , COR 4 and SO 2 R 4 ;

R 3 is selected from the group consisting of (1) CO 2 R 9 ; (2) C 1-6 alkyl optionally substituted with CN, OR 4 or NR 6 R′; (3) H; and (4) C 2-6 alkenyl substituted with CN;

Q is

B is —CH— or —N—;

A 1 is —C(O)— or —NH—;

A 2 is —CH 2 —, —CHR′— or —NR″—, wherein R′ is a halogen atom and R″ represents a hydrogen atom or a C 1 —C 4 alkyl, C 2 —C 4 alkenyl, C 3 —C 6 cycloalkyl, SO 2 , —(C 1 -C 6 alkyl), —SO 2 —N(C 1 -C 6 alkyl) 2 or —(CONH)a(C 1 -C 4 alkyl)-phenyl group, wherein a is 0 or 1, which group is unsubstituted or is substituted with a hydroxyl or cyano substituent; and

wherein component (b) is a compound of formula (V)

or a pharmaceutically acceptable salt thereof, wherein:

R 1 represents C 1-6 alkyl, aryl or heteroaryl;

R 2 represents hydrogen or C 1-6 alkyl;

each R 3 is the same or different and represents halogen, hydroxy, C 1-6 alkyl, C 1-6 alkoxy, C 1-6 alkylthio, C 1-6 haloalkyl, C 1-6 haloalkoxy, amino, mono(C 1-6 alkyl)amino, di(C 1 - 6 alkyl)amino, nitro, cyano, —CO 2 R′, —CONR′R″, —NH—CO—R′, —S(O)R′, —S(O) 2 R′, —NH—S(O) 2 R′, —S(O)NR′R″ or —S(O) 2 NR′R″, wherein each R′ and R″ is the same or different and represents hydrogen or C 1-6 alkyl;

n is from 0 to 3;

R 4 represents hydrogen or C 1-6 alkyl;

R 5 represents C 1-6 alkyl, aryl, heteroaryl, carbocyclyl, heterocyclyl, aryl-(C 1-6 alkyl)-, heteroaryl-(C 1-6 alkyl)-, carbocyclyl-(C 1-6 alkyl)-, heterocyclyl-(C 1-6 alkyl)-, aryl-(C 1-6 hydroxyalkyl)-, heteroaryl-(C 1-6 hydroxyalkyl)-, carbocyclyl-(C 1- 6 hydroxyalkyl)-, heterocyclyl-(C 1-6 hydroxyalkyl)-, aryl-C(O)—C(O)—, heteroaryl-C(O)—C(O)—, carbocyclyl-C(O)—C(O)—, heterocyclyl-C(O)—C(O)— or —XR 6 ;

X represents —CO—, —S(O)— or —S(O) 2 —; and

R 6 represents C 1-6 alkyl, hydroxy, C 1-6 alkoxy, C 1-6 alkylthio, aryl, heteroaryl, carbocyclyl, heterocyclyl, aryl-(C 1- 6 alkyl)-, heteroaryl-(C 1- 6 alkyl)-, carbocyclyl-(C 1- 6 alkyl)-, heterocyclyl-(C 1-6 alkyl)-, aryl-(C 1-6 alkyl)—O—, heteroaryl-(C 1-6 alkyl)-O—, carbocyclyl-(C 1-6 alkyl)-O —, heterocyclyl-(C 1-6 alkyl)-O— or —NR′R″ wherein each R′ and R″ is the same or different and represents hydrogen, C 1-6 alkyl, carbocyclyl, heterocyclyl, aryl, heteroaryl, aryl-(C 1-6 alkyl)-, heteroaryl-(C 1-6 alkyl)-, carbocyclyl-(C 1-6 alkyl)-, heterocyclyl-(C 1-6 alkyl)-aryl-(C 1-4 hydroxyalkyl)-, heteroaryl-(C 1-4 hydroxyalkyl)-, carbocyclyl-(C 1-4 hydroxyalkyl)-, or heterocycyl-(C 1-4 hydroxyalkyl)-; wherein the carbocyclyl, heterocyclyl, aryl, or heteroaryl groups are optionally substituted.

2. A composition according to claim 1 , wherein, in the compound of formula (V):

each R 3 is the same or different and represents halogen, hydroxy, C 1-6 alkyl, C 1-6 alkoxy, C 1-6 alkylthio, C 1-6 haloalkyl, C 1-6 haloalkoxy, amino, mono(C 1-6 alkyl)amino, di(C 1- 6 alkyl)amino, nitro, cyano, —CO 2 R′, —CONR′R″, —NH—CO—R′, —S(O)R′, —S(O) 2 R′, —NH—S(O) 2 R′ or —S(O)NR′R″, wherein each R′ and R″ is the same or different and represents hydrogen or C 1-6 alkyl;

″R 5 represents C 1-6 alkyl, aryl, heteroaryl, carbocyclyl, heterocyclyl, aryl-(C 1-6 alkyl)-, heteroaryl-(C 1-6 alkyl)-, carbocyclyl-(C 1-6 alkyl)-, heterocyclyl-(C 1-6 alkyl)- or —XR 6 ;

X represents —CO—, —S(O)— or —S(O) 2 -; and

R 6 represents C 1-6 alkyl, hydroxy, C 1-6 alkoxy, C 1-6 alkylthio, aryl, heteroaryl, carbocyclyl, heterocyclyl, aryl-(C 1-6 alkyl)-, heteroaryl-(C 1-6 alkyl)-, carbocyclyl-(C 1-6 alkyl)-, heterocyclyl-(C 1-6 alkyl)- or —NR′R″ wherein each R′ and R″ is the same or different and represents hydrogen, C 1-6 alkyl, carbocyclyl, heterocyclyl, aryl, heteroaryl, aryl-(C 1-6 alkyl)- or heteroaryl-(C 1-6 alkyl)-.

3. A composition according to claim 1 , wherein, in the compound of formula (V), R 1 is C 1-2 alkyl or aryl.

4. A composition according to claim 1 , wherein, in the compound of formula (V), R 2 is hydrogen.

5. A composition according to claim 1 , wherein, in the compound of formula (V), R 3 is halogen, hydroxy, C 1-4 alkyl, C 1-4 alkoxy, C 1-4 alkylthio, C 1-4 haloalkyl, C 1-4 haloalkoxy, amino, mono(C 1-4 alkyl)amino or di(C 1-4 alkyl)amino.

6. A composition according to claim 5 , wherein, in the compound of formula (V), R 3 is fluorine, chlorine, bromine, C 1-2 alkyl, C 1-2 alkoxy, C 1-2 alkylthio, C 1-2 haloalkyl, C 1-2 haloalkoxy, amino, mono(C 1-2 alkyl)amino or di (C 1-2 alkyl)amino.

7. A composition according to claim 5 , wherein, in the compound of formula (V), R 4 is hydrogen or C 1-2 alkyl.

8. A composition according to claim 1 , wherein, in the compound of formula (V), R 5 is C 1-6 alkyl, aryl, heteroaryl, carbocyclyl, heterocyclyl, aryl-(C 1-4 alkyl)-, heteroaryl-(C 1-4 alkyl)-, carbocyclyl-(C 1-4 alkyl)-, heterocyclyl- C 1-4 alkyl)-, aryl-C(O)—C(O)—, heteroaryl-C(O)—C(O)— or —XR 6 .

9. A composition according to claim 8 , wherein, in the compound of formula (V), R 5 is C 1-4 alkyl, aryl, heteroaryl, carbocyclyl, heterocyclyl, phenyl-(C 1-2 alkyl)-, heteroaryl-(C 1- 2 alkyl)-, phenyl-C(O)—C(O)—, heteroaryl-C(O)—C(O)— or —XR 6 .

10. A composition according to claim 9 , wherein, in the compound of formula (V), R 5 is C 1-4 alkyl, phenyl, thienyl, furanyl, isoxazolyl, pyridyl, cyclopentyl, cyclohexyl, benzothienyl, dihydrobenzofuranyl, phenyl-CH 2 -, furanyl-CH 2 -, phenyl-C(O)—C(O)—, thienyl-C(O)—C(O)- or —XR 6 .

11. A composition according to claim 1 , wherein, in the compound of formula (V), X is —CO— or —S(O) 2 -.

12. A composition according to claim 1 , wherein, in the compound of formula (V), when R 6 is a group NR′R″ wherein each R′ and R″ is the same or different and represents hydrogen, C 1-4 alkyl, aryl, carbocyclyl, heterocyclyl, aryl-(C 1- 4 alkyl)- or heteroaryl-(C 1-4 alkyl)-.

13. A composition according to claim 12 , wherein, in the compound of formula (V), when R 6 is a group —NR′R″ each R′ and R″ is the same or different and represents hydrogen, C 1-4 alkyl, phenyl, thienyl, cyclohexyl, cyclopentyl or phenyl-CH 2 -.

14. A composition according to claim 13 , wherein, in the compound of formula (V), when R 6 is a group —NR′R″ and one of R′ and R″ is hydrogen.

15. A composition according to claim 1 , wherein, in the compound of formula (V), R 6 is C 1-6 alkyl, hydroxy, C 1-6 alkoxy, C 1-6 alkylthio, aryl, heteroaryl, carbocyclyl, heterocyclyl, aryl-(C 1- 4 alkyl)-, heteroaryl-(C 1- 4 alkyl)-, carbocyclyl-(C 1-4 alkyl)-, heterocyclyl-(C 1-4 alkyl)-, aryl-(C 1- 4 hydroxyalkyl)-, heteroaryl-(C 1- 4 hydroxyalkyl)-, carbocyclyl-(C 1- 4 hydroxyalkyl)-, heterocyclyl-(C 1-4 hydroxyalkyl)-, aryl-(C 1-4 alkyl)-O—, heteroaryl-(C 1-4 alkyl)-O—, carbocyclyl-(C 1-4 alkyl)-O—, heterocyclyl-(C 1-4 alkyl)-O— or —NR′R″.

16. A composition according to claim 15 , wherein, in the compound of formula (V), R 6 is C 1-6 alkyl, C 1-6 alkoxy, C 1-6 alkylthio, aryl, heteroaryl, carbocyclyl, heterocycly, phenyl-(C 1- 2 alkyl)-, phenyl-(C 1- 2 alkyl)—O —, heteroaryl-(C 1-2 alkyl)-, phenyl-(C 1- 2 hydroxyalkyl)-, heteroaryl-(C 1 - 2 hydroxyalkyl)- or —NR′R″.

17. A composition according to claim 16 , wherein, in the compound of formula (V), R 6 is C 1-4 alkyl, C 1-4 alkoxy, phenyl, naphthyl, dihydrobenzofuranyl, benzodioxinyl, 9H-fluoren-9-onyl, indolyl, thienyl, furanyl, oxazolyl, isoxazolyl, pyrazolyl, pyridyl, benzothienyl, benzofuranyl, cyclopentyl, cyclohexyl, piperazinyl, piperidinyl, morpholinyl, phenyl-(C 1- 2 alkyl)-, phenyl-CH 2 —CH(OH)—, phenyl-CH(OH)—CH 2 -, phenyl-(C 1-2 alkyl)-O —, 1H-benzo[d]imidazol-2(3H)-onyl or —NR′R″.

18. A composition according to claim 1 , wherein, in the compound of formula (V), the benzodiazepine derivative of formula (V) is a benzodiazepine derivative of formula

wherein:

R 1 is phenyl or methyl;

R 3 is methyl or chlorine;

n is 0 or 1;

R 4 is hydrogen or methyl;

R 5 is phenyl-CH 2 -, furanyl-CH 2 -, thienyl-C(O)—C(O)— or —XR 6 ;

X is —CO— or —S(O) 2 -; and

R 6 is C 1-4 alkyl, C 1-4 alkoxy, phenyl, naphthyl, dihydrobenzofuranyl, benzodioxinyl, 9H—fluoren-9-onyl, indolyl, thienyl, furanyl, oxazolyl, isoxazolyl, pyrazolyl, pyridyl, benzothienyl, benzofuranyl, cyclopentyl, cyclohexyl, piperazinyl, piperidinyl, morpholinyl, phenyl-(C 1-2 alkyl)-, phenyl-CH 2 —CH(OH)-phenyl-CH(OH)—CH 2 -, phenyl-(C 1- 2 alkyl)-O—, 1H-benzo[d]imidazol-2(3H)-onyl or —NR′R″ wherein each R′ and R″ is the same or different and represents hydrogen, C 1-4 alkyl, phenyl, thienyl, cyclohexyl, cyclopentyl or phenyl-(CH 2 )-, the phenyl moiety in the group R 1 being unsubstituted or substituted by a single fluorine, chlorine, C 1-2 alkyl, C 1-2 alkoxy, C 1-2 alkylthio, C 1-2 haloalkyl or C 1-2 haloalkoxy substituent;

the aryl moieties in the groups R 5 and R 6 being unsubstituted or substituted by 1, 2 or 3 substituents selected from fluorine, chlorine, bromine, iodine, C 1-4 alkyl, C 2-4 acyl, hydroxy, C 1-4 alkoxy, C 1-4 alkylthio, C 1-4 haloalkyl, C 1-4 haloalkoxy, amino, mono(C 1-4 alkyl)amino, di(C 1- 4 alkyl)amino, nitro, —CO 2 R′, —S(O) 2 R′ and —S(O) 2 NH 2 , wherein R′ represents C 1-2 alkyl;

the heteroaryl moieties in the groups R 5 and R 6 being unsubstituted or substituted by 1 or 2 substituents selected from fluorine, chlorine, bromine, C 1-2 alkyl, C 1-2 haloalkyl and di(C 1- 2 alkyl)amino; and

the heterocyclyl and carbocyclyl moieties in the R 6 group being unsubstituted or substituted by 1 or 2 substituents selected from fluorine, chlorine, bromine, C 1-4 alkyl, C 1-4 alkoxy, C 1-4 haloalkyl and nitro.

19. A composition comprising a pharmaceutically acceptable carrier or diluent and:

(a) an inhibitor of the RSV fusion protein; and

(b) a benzodiazepine derivative capable of inhibiting RSV replication wherein component (a) is a compound of formula (I);

or a pharmaceutically acceptable salt thereof, wherein:

X is a direct link

Y is;

Z is CR 6 R′, where R 6 is H, or straight, branched or cyclic C 1-6 alkyl and R′ is straight, branched or cyclic C 1-6 alkyl;

R 1 is H, CONR 4 R 5 , CO 2 R 4 or C 1-6 alkyl, said C 1-6 alkyl can be optionally substituted with OR 4 or NR 8 R 9 ;

R 4 and R 5 are H or C 1-6 alkyl;

R 8 and R 9 are each independently H, C 1-6 alkyl, SO 2 R 5 , CO 2 R 4 or COR 4 ;

R 2 is selected from the group consisting of H, NH 2 , CONR 6 R′, heteroaryl, C 2-6 alkenyl, CO 2 R 4 , N═CPh 2 , C(═NH)NH 2 and C 1-6 alkyl; said alkyl optionally substituted with a member selected from the group consisting of halogen, CN, NR 10 R 11 , OSO 2 R 4 and OR 4 ;

R 10 and R 11 are each independently selected from the group consisting of H, C 1-6 alkyl, C 3-6 cycloalkyl, CO 2 R 4 , COR 4 and SO 2 R 4 ;

R 3 is selected from the group consisting of (1) CO 2 R 9 ; (2) C 1-6 alkyl optionally substituted with CN, OR 4 or NR 6 R′; (3) H; and (4) C 2-6 alkenyl substituted with CN;

Q is

B is —CH— or —N—;

A l is —C(O)— or —NH—;

A 2 is —CH 2 -, —CHR′- or —NR″-, wherein R′ is a halogen atom and R″ represents a hydrogen atom or a C 1-4 alkyl, C 2 -C 4 alkenyl, C 3 -C 6 cycloalkyl,SO 2 ,-(C 1 -C 6 alkyl), —SO 2 —N(C 1 -C 6 alkyl) 2 or -(CONH)a(C 1 -C 4 alkyl)-phenyl group, wherein a is 0 or 1, which group is unsubstituted or is substituted with a hydroxyl or cyano substituent; and

wherein component (b) is selected from:

Cyclohexanecarboxylic acid 2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

3-Methoxy N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

4-Methoxy N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

2-Methoxy N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

N-(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-3-trifluoromethyl-benzamide;

N-(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

Thiophene-2-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl )-3-amide;

Furan-2-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

Piperidine-1-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3yl )-amide;

Morpholine-4-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

4-Nitro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

3-Nitro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

4-Methyl-piperazine-l-carboxylic acid-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

3,4-Dichloro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-2-trifluoromethyl-benzamide;

4-Bromo-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

2-Methyl-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

2-Chloro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

2-Nitro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

2-Methoxy-4-nitro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

(S)-2-Methoxy-4-nitro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

Benzo[b]thiophene-3-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e] [1,4]diazepin-3-yl)-amide;

2,3-Dihydro-benzofuran-5-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

Isoxazole-5-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl )-amide;

Benzo[b]thiophene-2-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

Thiophen-3-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl )-amide;

N-(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-isonicotinamide;

N-(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo [e][1,4]diazepin-3-yl)-nicotinamide;

N-(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-methanesulfonamide;

Propane-l-sulfonic acid-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

Butane-l-sulfonic acid-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

2-Bromo-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzenesulfonamide;

3-Bromo-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzenesulfonamide;

4-Bromo-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzenesulfonamide;

2-Fluoro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzenesulfonamide;

3-(2-Nitro-benzylamino)-5-phenyl-1,3-dihydro-benzo[e][1,4]diazepin-2-one;

3-(3-Nitro-benzylamino)-5-phenyl-1,3-dihydro-benzo[e][1,4]diazepin-2-one;

3-(4-Nitro-benzylamino)-5-phenyl-1,3-dihydro-benzo[e][1,4]diazepin-2-one;

3-(2-Methoxy-benzylamino)-5-phenyl-1,3-dihydro-benzo[e][1,4]diazepin-2-one;

3-(3-Methoxy-benzylamino)-5-phenyl-1,3-dihydro-benzo[e][1,4]diazepin-2-one;

5-Phenyl-3-(2-trifluoromethyl-benzylamino)-1,3-dihydro-benzo[e][1,4]diazepin-2-one;

5-Phenyl-3-(3-trifluoromethyl-benzylamino)-1,3-dihydro-benzo[e][1,4]diazepin-2-one;

5-Phenyl-3-(4-trifluoromethyl-benzylamino)-1,3-dihydro-benzo[e][1,4]diazepin-2-one;

3-[(Furan-2-ylmethyl)-amino]-5-phenyl-1,3-dihydro-benzo[e][1,4]diazepin-2-one;

N-(7-Chloro-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-acetamide;

N-(7-Chloro-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-isobutyramide;

N-(7-Chloro-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-methanesulfonamide;

Furan-2-carboxylic acid (7-chloro-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

Thiophene-2-carboxylic acid (7-chloro-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

Cyclohexanecarboxylic acid (7-Chloro-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

N-(7-Chloro-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-2-methoxy-benzamide;

N-(7-Chloro-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-4-methoxy-benzamide;

N-(7-Chloro-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-2-nitro-benzamide;

2-(2-Methoxy-phenyl)N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-acetamide;

2-(3-Methoxy-phenyl)N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-acetamide;

2-(4-Methoxy-phenyl)N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-acetamide;

2-(4-Nitro-phenyl)N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-acetamide;

2-(3-Nitro-phenyl)N- (2-oxo-5-phenyl-2,3-dihydro-1H-benzo [e][1,4]diazepin-3-yl)-acetamide;

N-(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-2- (2-trifluoromethyl-phenyl)-acetamide;

N-(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-2- (3 -trifluoromethyl-phenyl)-acetamide;

N-(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-2- (4-trifluoromethyl-phenyl)-acetamide;

1- (2-Methoxy-phenyl)-3- (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-(2-Nitro-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-(2-Chloro-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-(4-Chloro-phenyl)-3- (2-oxo-5-phenyl-2,3-dihydro- 1H-benzo[e][1,4]diazepin-3-yl-urea;

1-(2-oxo-5-phenyl-2,3-dihydro- 1H-benzo[e][1,4]diazepin-3-yl)-3-p-tolyl-urea;

1-(2-Fluoro-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-(4-Fluoro-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

(S)-1-(2-Fluoro-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

4-Methanesulfonyl-2-methoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e] [1,4]diazepin-3-yl)-benzamide;

(S)-4-Methanesulfonyl-2-methoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

5-Acetyl-2-ethoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

(S)-5-Acetyl-2-ethoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

6-Fluoro-4H-benzo[1,3]dioxine-8-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

(S)-6-Fluoro-4H-benzo[1,3]dioxine-8-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

(S)-2-Methoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-4-trifluoromethyl-benzamide;

2,4,5-Trifluoro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

(S)-2,4,5-Trifluoro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

2-Hydroxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

(S)-2-Hydroxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

1H-Indole-7-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl )-amide;

(S)-1H-Indole-7-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

3-Methoxy-naphthalene-2-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H—benzo[e][1,4]diazepin-3-yl)-amide;

(S)-3-Methoxy-naphthalene-2-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H—benzo[e][1,4]diazepin-3-yl)-amide;

N-[7-Chloro-5-(2-fluoro-phenyl)-2-oxo-2,3-dihydro-1H-benzo[e][1,4]diazepine-3-yl]-4-methoxoy-benzamide;

1-(2-Fluoro-benzyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-(4-Methoxy-benzyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-(3-Methyl-benzyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-3-(4-trifluoromethyl-phenyl)-urea;

4-Chloro-2-methoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

4-Methoxy-3-nitro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)benzamide;

3-Methoxy-2-nitro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

5-Chloro-2-methoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)benzamide;

5-Fluoro-2-methoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

2-Methoxy-4-nitro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

5-Methoxy-2-nitro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

3-Methoxy-4-nitro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

3-(2-Methoxy-phenyl)-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)propionamide;

3-(3-Methoxy-phenyl)-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-propionamide;

3-(4-Methoxy-phenyl)-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-propionamide;

N-[5-(3-Chloro-phenyl)-2-oxo-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-2-methoxy-benzamide;

N-[5-(3-Chloro-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-4-methoxy-benzamide;

N-[5-(3-Chloro-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-2-nitro-benzamide;

N-[5-(3-Chloro-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-4-nitro-benzamide;

4-Methoxy-N-[2-oxo-5-(4-trifluoromethyl-phenyl)-2,3-dihydro-1H-benzo[e] [1,4]diazepin-3-yl]-benzamide;

2-Methoxy-N-[2-oxo-5-(3-trifluoromethyl-phenyl)-2,3-dihydro-1H-benzo[e] [1,4]diazepin-3-yl]-benzamide;

4-Methoxy-N- [2-oxo-5- (3-trifluoromethyl-phenyl)-2,3-dihydro-1H-benzo [e] [1,4]diazepin-3-yl]-benzamide;

2-Ethoxy-N- (2-oxo-5-phenyl-2,3-dihydro-1H-benzo [e][1,4]diazepin-3-yl)-benzamide;

2,4-Dimethoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

2-Bromo-5-methoxy-N- (2-oxo-5-phenyl-2,3-dihydro-1H-benzo [e][1,4]diazepin-3-yl)-benzamide;

2-Methoxy-N- [5-(3-mehtoxy-phenyl)-2-oxo-2,3-dihydro-1H-benzo [e][1,4]diazepin-3-yl]-benzamide N-[5-(3-Methoxy-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]4-nitro-benzamide;

2-Methoxy-N- (8-methyl-2-oxo-5-phenyl-2,3-dihydro-1H-benzo [e][1,4]diazepin-3-yl)-benzamide;

2-Chloro-4-methanesulfonyl-N- (2-oxo-5-phenyl-2,3-dihydro-1H-benzo [e][1,4]diazepin-3-yl )-benzamide;

2-Dimethylamino-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo [e][1,4]diazepin-3-yl)-benzamide;

(2Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-carbamic acid benzyl ester;

1-(3,5-Dimethyl-phenyl)-3- (2-oxo-5-phenyl-2,3-dihydro-1H-benzo [e][1,4]diazepin-3-yl)-urea;

1-(2Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-3-(4-trifluoromethoxy-phenyl)-urea;

1-(4-Bromo-2-trifluoromethyl-phenyl)-3- (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-(4-Bromo-benzyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo [e][1,4]diazepin-3-yl)-urea;

1-(2,3-Dichloro-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo [e][1,4]diazepin-3-yl)-urea;

1-(2,6-Dimethyl-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo [e][1,4]diazepin-3-yl)-urea;

1-(2-Chloro-6-methyl-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-(4-Nitro-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-(2-Methylsulfanyl-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl )-urea;

1-(2,6-Dichloro-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

5-tert-Butyl-2-methoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

2,5-Dimethoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

1-(2,6-Difluoro-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-(3-Fluoro-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-(3-Methoxy-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-3-(3-trifluoromethyl-phenyl)-urea;

1-(3-Chloro-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e]1,4]diazepin-3-yl)-urea;

2-Methoxy-4-methylsulfanyl-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl )-benzamide;

4-Methanesulfonyl-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

N-(2Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)terephthalamic acidmethyl ester;

2-Fluoro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

2,6-Difluoro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

N-(2-Oxo-5-phenyl-2, 3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-2-propoxy-benzamide;

2-Iodo-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

3-Methoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-terephthalamic acid methyl ester;

4-Amino-5-chloro-2-methoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e] [1,4]diazepin-3-yl)-benzamide;

1-(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-3-m-tolyl-urea;

2-Methylsulfanyl-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide;

2-Methoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-5-sulfamoyl-benzamide;

2-Hydroxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-3-phenyl-propionamide 3-Hydroxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-3-phenyl-propionamide;

3-(2-Fluoro-phenyl)-1-methyl-1-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin3-yl)-urea;

2-Methoxy-N-methyl-4-nitro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin3-yl)-benzamide;

1-tert-Butyl-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

-1-Cyclohexyl-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-Ethyl-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

1-Butyl-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea;

4,5-Dimethyl-furan-2-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e] [1,4]diazepin-3-yl)amide;

Piperidine-l-carboxylic acid (7-chloro-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e] [1,4]diazepin-3-yl)-amide;

N-[5-(3-Chloro-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)acetamide;

N-[5-(3-Chloro-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-isobutyramide;

Furan-2-carboxylic acid [5-(3-chloro-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-amide;

Thiophene-2-carboxylic acid [5-(3-chloro-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-amide;

Cyclohexanecarboxylic acid [5-(3chloro-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1Hbenzo[e][1,4]diazepin-3-yl]-amide;

Piperidine-l-carboxylic acid [5-(3-chloro-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-amide;

N-[5-(3-Chloro-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1H-benzo [e][1,4]diazepin-3-yl]isonicotinamide;

5-Methyl-furan-2-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

Pyrazine-2-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

N-[5- (3-Methoxy-phenyl)-2-oxo-5-phenyl2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-is obutyramide;

Thiophene-2-carboxylic acid [5-(3-methoxy-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-amide;

Cyclohexanecarboxylic acid [5-(3-methoxy-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-amide;

Piperidine- l -carboxylic acid [5-(3-methoxy-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-amide;

Piperidine-4-carboxylic acid [5-(3-methoxy-phenyl)-2-oxo-5-phenyl-2,3-dihydro-1 H-benzo[e][1,4]diazepin-3-yl]-amide;

Cyclohexanecarboxylic acid (8-chloro-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e] [1,4]diazepin-3-yl)-amide;

Thiophene-2-carboxylic acid (8-methyl-2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

1-(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl )-3-thiophene-2-yl-urea;

1-(2-Oxo-5-phenyl-2,3-dihydro- 1H-benzo [e][1,4]diazepin-3-yl)-3-thiophene-3-yl-urea;

Pyridine-2 -carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

1H-Pyrazole-4-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1 H-benzo[e][1,4]diazepin-3-yl)-amide;

6-Dimethylamino-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-nicotinamide;

2-Ethoxy-naphthalene-1 -carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

9-Oxo-9H-fluorene-1 -carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e] [1,4]diazepin-3-yl)-amide;

2-Oxo-2,3-dihydro-benzoimidazole-1 -carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-amide;

(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)carbamic acid tert-butyl ester;

(S)-4,5-Dibromo-furan-2-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1 ,4]diazepin-3-yl)-amide;

(S)-Benzofuran-2-carboxylic acid (2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1 ,4]diazepin-3-yl)-amide;

(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-carbamic acid methyl ester;

(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1 ,4]diazepin-3-yl)-carbamic acid ethyl ester;

(2-Oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-carbamic acid isobutyl ester; or 2-Oxo-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1 ,4]diazepin-3-yl)-2-thiophene-2-yl-acetamide; or a pharmaceutically acceptable salt thereof.

20. A composition according to claim 19 , wherein the benzodiazepine derivative of formula (V) is 1-(2-fluoro-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea, 2-methoxy-4-nitro-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-benzamide or 4-methanesulfonyl-2-methoxy-N-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1 ,4]diazepin-3-yl)-benzamide.

21. A composition according to claim 19 , wherein the benzodiazepine derivative of formula (V) is 1-(2-fluoro-phenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl)-urea.

22. A composition comprising a pharmaceutically acceptable carrier or diluent and:

(a) an inhibitor of the RSV fusion protein; and

(b) a benzodiazepine derivative capable of inhibiting RSV replication, wherein component (a) is selected from:

1-Cyclopropyl-3-[1-(4-hydroxy-butyl)-1H-benzoimidazol-2-ylmethyl]-1,3-dihydro-imidazo[4,5-c]pyridin-2-one;

1-Isopropenyl-3-[1-(3-methyl-butyl)-1H-benzoimidazol-2-ylmethyl]-1,3-dihydro-benzoimidazol-2-one;

1-(4-Hydroxy-benzyl)-3-[1-(3-methyl-butyl)-1H-benzoimidazol-2-ylmethyl]-1,3-dihydro-benzoimidazol-2-one;

1-Isopropenyl-3-[1-(3-oxo-butyl)-1H-benzoimidazol-2-ylmethyl]-1,3-dihydro-benzoimidazol-2-one;

1-Ethyl-3-[1-(2-hydroxy-2-phenyl-ethyl)-1H-benzoimidazol-2-ylmethyl]-1,3-dihydro-benzoimidazol-2-one;

1-Ethyl-3-[1-(4-hydroxy-butyl)-1H-benzoimidazol-2-ylmethyl]-1,3-dihydro-benzoimidazol-2-one;

5-{3-[1-(3-Methanesulfonyl-propyl)-1H-benzoimidazol-2-ylmethyl]-2-oxo-2,3-dihydro-benzoimidazol-1-yl }-pentanenitrile;

3-[1-(3-Methyl-butyD-1H-benzoimidazol-2-ylmethyl]-2-oxo-2,3-dihydro-benzoimidazol-1-carboxylic acid benzylamide;

1-Methanesulfonyl-3-[1-(3-methyl-butyl)-1H-benzoimidazol-2-ylmethyl]-1,3-dihydro-benzoimidazol-2-one;

3-[1-(3-Methyl-butyl)-1H-benzoimidazol-2-ylmethyl]-2-oxo-2,3-dihydro-benzoimidazol-1 -sulfonic acid dimethylamide; or

1-Isopropenyl-3-(1-propyl-1H-benzoimidazol-2-ylmethyl)-1,3-dihydro-imidazo[4,5-c]pyridine-2-one;

or a pharmaceutically acceptable salt thereof; and

wherein component (b) is a compound of formula (V), or a pharmaceutically acceptable salt thereof,

wherein:

R 1 represents C 1-6 alkyl, aryl or heteroaryl;

R 2 represents hydrogen or C 1-6 alkyl;

each R 3 is the same or different and represents halogen, hydroxy, C 1-6 alkyl, C 1-6 alkoxy, C 1-6 alkylthio, C 1-6 haloalkyl, C 1-6 haloalkoxy, amino, mono(C 1-6 alkyl)amino, di(C 1 - 6 alkyl)amino, nitro, cyano, —CO 2 R′, —CONR′R″, —NH—CO—R′, —S(O)R′, —S(O) 2 R′, —NH—S(O) 2 R′, —S(O)NR′R″ or —S(O) 2 NR′R″, wherein each R′ and R″ is the same or different and represents hydrogen or C 1-6 alkyl;

n is from 0 to 3;

R 4 represents hydrogen or C 1-6 alkyl;

R 5 represents C 1-6 alkyl, aryl, heteroaryl, carbocyclyl, heterocyclyl, aryl-(C 1 - 6 alkyl)-, heteroaryl-(C 1 - 6 alkyl)-, carbocyclyl-(C 1 - 6 alkyl)-, heterocyclyl-(C 1 - 6 alkyl)-, aryl-(C 1 - 6 hydroxyalkyl)-, heteroaryl-(C 1-6 hydroxyalkyl)-, carbocyclyl-(C 1-6 hydroxyalkyl)-, heterocyclyl-(C 1-6 hydroxyalkyl)-, aryl-C(O)—C(O)-, heteroaryl-C(O)—C(O)-, carbocyclyl-C(O)—C(O)-, heterocyclyl-C(O)—C(O)- or —XR 6 ;

X represents —CO—, —S(O)- or —S(O) 2 -; and

R 6 represents C 1-6 alkyl, hydroxy, C 1-6 alkoxy, C 1-6 alkylthio, aryl, heteroaryl, carbocyclyl, heterocyclyl, aryl-(C 1-6 alkyl)-, heteroaryl-(C 1-6 alkyl)-, carbocyclyl-(C 1-6 alkyl)-, heterocyclyl-(C 1-6 alkyl)-, aryl-(C 1-6 alkyl)-O—, heteroaryl-(C 1-6 alkyl)—O —, carbocyclyl-(C 1-6 alkyl)—O—, heterocyclyl-(C 1 - 6 alkyl)—O— or —NR′R″ wherein each R′ and R″ is the same or different and represents hydrogen, C 1-6 alkyl, carbocyclyl, heterocyclyl, aryl, heteroaryl, aryl-(C 1-6 alkyl)-, heteroaryl-(C 1-6 alkyl)-, carbocyclyl-(C 1-6 alkyl)- or heterocyclyl-(C 1-6 alkyl)-.

23. A composition according to claim 22 , wherein component (a) is 1-cyclopropyl-3-[1-(4-hydroxy-butyl)-1H-benzoimidazol-2-ylmethyl]-1,3-dihydro-imidazo[4,5-c]pyridin-2-one; or a pharmaceutically acceptable salt thereof.

24. A composition according to claim 22 , wherein component (a) is 1-cyclopropyl-3-[1-(4-hydroxy-butyl)-1H-benzoimidazol-2-ylmethyl]-1,3-dihydro-imidazo[4,5-c]pyridin-2-one or 1-Isopropenyl-3-(1-propyl-1H-benzoimidazol-2-ylmethyl)-1,3-dihydro-imidazo[4,5-c]pyridine-2-one, or a pharmaceutically acceptable salt thereof.

25. A composition according to claim 1 , wherein component (a) is present in an amount of from 0.025 wt % to 10 wt %.

26. A composition according to claim 1 , wherein component (b) is present in an amount of 0.025 wt % to 10 wt %.

27. A composition according to claim 1 , for use in the treatment of the human or animal body.

28. A method of treating an RSV infection in a patient, which method comprises the administration to said patient of:

(a) an RSV fusion protein inhibitor as defined in claim 1 ; and

(b) a benzodiazepine derivative as defined in claim 1 .