home - ergomed - peprostat top line phase ii data · 2019-04-24 · ergo haemostatix data 23 oct...

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TRANSFORMING DRUG DEVELOPMENT

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PeproStatTop line Phase II data

23 October 2017

www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com

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GLOBAL MARKET EST. $2.5 BILLION, GROWING 6-8% PAPEPROSTAT, FIRST IN CLASS BLOOD-FREE HAEMOSTAT

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PATENTED FIBRINOGEN-BINDING PEPTIDE TECHNOLOGYFOR SURGICAL BLEEDING

• Rapid and effective control of bleeding is essential for safe procedures

• Every ten minutes of theatre time costs of £200*

• Ergomed’s first in class haemostats replace blood-derived thrombin, the leading therapy in use.

• Blood-free• Ready to use• Rapid action*NHS Institute for Innovation and

Improvement Report, 2009


POSITIVE PHASE II RESULTSPEPROSTAT HIGHLIGHTS

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PRIMARY ENDPOINT MET

• PeproStat superior to standard of care across threesurgery types tested

• Clinically and statistically significant

• Good safety profile

• Good investigator opinion


OVERVIEW

STUDY DESIGN

• Randomized, blinded, parallel-group, multicenter controlled clinical trial

• Three different surgery types: Open liver/soft tissue, vascular, spine

• 169 patients treated (162 evaluable) at 16 sites in five European states

• Treatment PeproStat compared to Standard of Care (saline soaked into haemostatic gelatin sponge) in ratio: 2 : 1

• Primary endpoint: Demonstrate superiority of PeproStat in time to hemostasis (time to stopping bleed) within 10 minutes compared to Standard of Care

• Secondary endpoints included investigator assessment of ease of use


PRIMARY ENDPOINT MET: SUPERIOR TO STANDARD OF CARE ACROSS THREE SURGERY TYPES

PEPROSTAT PHASE II RESULTS

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• Efficacy • Reduced mean TTH (Time to Haemostasis) by 1.55 minutes vs. standard of care• Clinically and statistically significant result • Good safety profile: no treatment-related SAE

Mean difference p-value p-valuePeprostat on sponge vs Saline on sponge

for t-test for Wilcoxon

sign-rank testAll surgeries -1.55 0.0041 0.0066

Surgery type


TIME TO ACHIEVEMENT OF HEMOSTASIS WITHIN 10 MINUTES

EFFICACY RESULTS

• PeproStat reduced TTH across all surgery types tested• Absolute TTH relatively higher than other trials for both products• Most likely due to severity of bleeding

N Mean Median

PeproStat + sponge 110 4.2 3

Saline + sponge 52 5.8 5

Difference 1.6

Surgery type / Treatment groupTime to hemostasis

All surgeries


INVESTIGATOR RESPONSE DRIVES SALES PENETRATION

INVESTIGATOR ASSESSMENT OF EFFICACY & EASE OF USE

• 80.9% surgeons rated PeproStat (blinded) as good to excellent in controlling bleeding vs 59.6% for standard of care

• 93.5% rated the “liquid and sponge” format as easy/very easy to use


OVERVIEW & NEXT STEPS

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CLINICALCOMMERCIAL

• First-in-class, patented product

• $2.5Bn global market

• Synthetic, blood-free

• Easy-to-use

• Fast to market, launch 2020

NEXT STEPS

Licensing / partnering• Boryung, S. Korea• Multiple ongoing discussions

• Phase II complete (cum. 190 pts)

• Primary Endpoints met

• Safe

• Effective, TTH

• Highly rated by surgeons

NEXT STEPS

Phase III• 600 pts, £10m• Complete recruitment 2019


QUESTIONS?

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Building a profitable services businesscombined with

sustainable product development

for significant shareholder value.

OUR MISSION

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Balanced downside protection and upside potentialHYBRID BUSINESS MODEL

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PROFITABLE, FAST GROWING, PREDICTABLE

BREAK-OUT UPSIDE POTENTIAL

SERVICES PRODUCTS

Global platform

Full range of services

EBITDA accretive acquisition opportunities

Diversified portfolio

Multiple shots on goal

Managed risk approach


Blood-free, ready-to-use, fast actionPEPROSTAT

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READY TO USE LIQUID• Applied with resorbable sponge to wound

surfaces• Sponge can be cut to fit space needed

UNIQUE OPPORTUNITY IN EUROPE• Pure thrombin not available• Sponge volumes similar to USA• USA pure thrombin sales ~ $180million

ESTABLISHED MARKET IN USA• Pure thrombin used with 80% of sponges• JMI & Evithrom are blood-derived• JMI, Evithrom and Recothrom require re-

constitution or thawing prior to use


PEPROSTAT STATUS

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PHASE II COMPARATIVE TRIAL COMPLETED• 169 patients • Soft tissue/ liver, vascular, spinal• Fast recruitment

FAST TO MARKET• Phase III 2018/2019 - 600 patients• US & EU

1.4 min(PeprostatTM)

3 to 6 min (Competitors)

vs

> $200m sales potential

MARKET POTENTIAL• Strong patent protection• Clear competitive advantage• Estimated global sales: > $200m

2020 market entry

PHASE I NON COMPARATIVE• 20 liver resection surgery patients• Good safety profile• TTH 1.4 minutes; 95% bleeds stopped within 3minutes

Reduced TTH by 1.55 minutes vs standard of care

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