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Page 1: CLINICAL STUDIES AVANCEMENT STUDIES RELEVANCE FDA … · drug name type 1 0 1 0 1 0 1 0 0 1 0 1 0 1 0 1 serologichistologic alat levels enhanced 1 0 steatosis enhanced 1 0 ballonning

Drug name

Type

1 0

1 0

1 0

1 0

0 1

0 1

0 1

0 1

Serologic HistologicALAT LEVELS ENHANCED 1 0

STEATOSIS ENHANCED 1 0

BALLONNING ENHANCED 0 0

LOBULAR INFLAMMATION ENHANCED 0 0

PORTAL INFLAMMATION ENHANCED 0 0

ON NAS SCORE >=4 0 0

NAS SCORE ENHANCED BY MIN 2 POINTS 1 0

NASH REVERSION WITHOUT WORSENING OF FIBROSIS 1 0

FIBROSIS SCORE ENHANCED 0 0

OTHER BENEFITS 0 0

WEIGHT LOSS 1 0

LIPIDIC PROFILE ENHANCED 0 0

INSULIN SENSITIVITY ENHANCED 1 0

NAS SCORE Yes NoNAFLD 0 1

NAS 3 1 0

NAS 4 1 0

NAS 5 1 0

NAS 6 1 0

NAS 7 1 0

NAS 8 1 0

FIBROSIS SCORE Yes NoF0 - NO FIBROSIS 1 0

F1 1 0

F2 1 0

F3 1 0

F4 - CIRRHOSIS 1 0

PATIENTS WITH CARDIOVASCULAR RISK Yes NoEXCLUSION 0 1

INCLUSION 1 0

PATIENTS WITH T2 DIABETES Yes NoEXCLUSION 0 1

INCLUSION 1 0

©  G.DIVRY  2015  -­‐  WWW.NASHBIOTECHS.COM

TARGETED MARKET CRITERIAS TARGETED NASH MARKET SEGMENTS AND SIZE

GRANITE LIKE AREA ARE EXCLUDED MARKET SEGMENTS

CONFIDENCE IN SUCCESS POSOLOGY1,8mg

Once a day

ANOREXIA 0

SUBCUTANEOUS 1

PRURIT#REF!

PER OS 0

LIPIDIC PROFILE WORSENED 0

INTRAVENOUS 0

INSULIN SENSIVITY WORSENED 0

INTRAMUSCULAR 0

NO WORSENING OF FIBROSIS

CLINICAL STUDIES RESULTS

#

ADVERSE EFFECTS ADMINISTRATION MODE

Serious or Moderate

OTHER TREATMENT STABILIZED

PROVED DOSE/EFFECT RELATIONSUBPART H ELIGIBLE

0NASH REVERSION CRITERIA

SEROLOGICAL CRITERIAS

HISTOLOGIC CRIT ON STARTFAST TRACK

0HISTOLOGIC CRIT AT END

CENTRALIZED READING BREAKTHROUGH THERAPY

0

glukagon like peptide

CLINICAL STUDIES AVANCEMENT STUDIES RELEVANCE FDA STATUS

NASH BIOTECH OVERVIEW NOVO NORDISKVICTORZA

7%  

7%  

8%  

10%  

2%  

5%  

5%  

6%  8%  

2%  

5%  

2%  

3%  

3%  

1%  

6%  

5%  

6%  

7%  2%  

MARKET �ESTIMED SIZE �

Billions $ � 31,1 �

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