clinical studies avancement studies relevance fda … · drug name type 1 0 1 0 1 0 1 0 0 1 0 1 0 1...

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Drug name Type 1 0 1 0 1 0 1 0 0 1 0 1 0 1 0 1 Serologic Histologic ALAT 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 No NAFLD 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 No F0 - NO FIBROSIS 1 0 F1 1 0 F2 1 0 F3 1 0 F4 - CIRRHOSIS 1 0 PATIENTS WITH CARDIOVASCULAR RISK Yes No EXCLUSION 0 1 INCLUSION 1 0 PATIENTS WITH T2 DIABETES Yes No EXCLUSION 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 POSOLOGY 1,8mg 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 RELATION SUBPART H ELIGIBLE 0 NASH REVERSION CRITERIA SEROLOGICAL CRITERIAS HISTOLOGIC CRIT ON START FAST TRACK 0 HISTOLOGIC CRIT AT END CENTRALIZED READING BREAKTHROUGH THERAPY 0 glukagon like peptide CLINICAL STUDIES AVANCEMENT STUDIES RELEVANCE FDA STATUS NASH BIOTECH OVERVIEW NOVO NORDISK VICTORZA 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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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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