Renovo Group plc

1
Renovo Group plc
Juvista Trial Results RN1001-1009
RN1001-1010 3 March 2008
Renovo is listed on the main market of the London
Stock Exchange (RNVO) For further information
please visit our web site www.renovo.com
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Highlights

• Scar revision met its primary endpoint
• dosed twice, once at the time of surgery and once
  24 hours later
• Breast augmentation did not meet its primary
  endpoint
• dosed once, at the time of surgery
• Cumulative data from recently reported trials
  indicate that Juvistas efficacy is greater when
  given twice
• European Phase 3 trial planned to commence in H2
  2008 in scar revision surgery, likely with 200ng
  and 500ng dosed twice
• Large scar reduction market remains accessible to
  Juvista strategy to achieve this is being
  updated
• Juvistas use in scar revision surgery, a
  procedure carried out by Plastic Surgeons and
  Cosmetic Dermatologists, is an example of the
  prophylactic use of the drug to reduce subsequent
  scarring
• Favourable safety profile AEs and tolerability

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1009 Scar Revision Phase 2 Study Design

• Double-blind, placebo-controlled, within-patient
  trial to investigate the safety and efficacy of
  200ng per 100?l per linear cm wound margin of
  Juvista when administered twice following scar
  revision surgery
• Trial divided into two groups in order to
  evaluate the efficacy of Juvista in two different
  scar revision surgical procedures
• First group scar excised in one stage (most
  common procedure)
• Second group scar excised in two stages
• 30 patients (male and female) in each group,
  giving a total trial size of 60 patients
• First group reports today, second group is fully
  recruited and due to report in H2 2008

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1009 Scar Revision Study Design Group 1

• Scars excised in one surgical procedure
• 30 patients with linear scars ranging from at
  least 5cm to 16cm in length and suitable for
  revision by excision and direct closure
• one end segment allocated to receive active
  treatment
• the opposite segment allocated to receive placebo
• middle segment left untreated
• 200ng per 100?l per linear cm wound margin
  injected intradermally twice once at time of
  surgery immediately following wound closure and
  once 24 hours later
• Primary assessment based on a photographic
  evaluation by a lay panel over a time period from
  week 6 to month 7 post surgery using a visual
  analogue scale (VAS)

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1009 Scar Revision Procedure Diagram
Original Scar
Excision
Juvista/Placebo

• Juvista/Placebo

Untreated
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1009 Scar RevisionGroup 1 Conclusions

• Primary endpoint was met with statistical
  significance (p0.028)
• Efficacy was demonstrated in poorer scars than
  previously studied
• Efficacy was demonstrated in larger scars than
  previously studied
• Favourable safety profile AEs and tolerability

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Trial 1009 Results Day 0
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Trial 1009 Results Month 1
Placebo
Juvista
10
Trial 1009 Results Month 2
Placebo
Juvista
11
Trial 1009 Results Month 3
Placebo
Juvista
12
Trial 1009 Results Month 4
Placebo
Juvista
13
Trial 1009 Results Month 5
Placebo
Juvista
14
Trial 1009 Results Month 6
Placebo
Juvista
15
Trial 1009 Results Month 7
Placebo
Juvista
16
Trial 1009 Results Month 9
Placebo
Juvista
17
Trial 1009 Results Month 12
Placebo
Juvista
18
Trial 1009 Results Month 12
Placebo
Juvista
19
Trial 1009 Results Month 12
Placebo
Juvista
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1010 Breast AugmentationPhase 2 Study Design

• Double-blind, within-patient, placebo-controlled
  Phase 2 study to investigate the safety and
  efficacy of Juvista following bilateral breast
  augmentation surgery
• Each patient administered 50ng or
  200ng/100?L/linear cm of Juvista once
  intradermally along both margins of one breast
  wound immediately following surgery
• 31 patients in 50ng group and 32 patients in
  200ng group

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1010 Breast AugmentationConclusions

• Trial did not meet its primary endpoint
• assessment of standardised photographs of the
  scars by a lay panel 12 months post surgery using
  a VAS
• Efficacy of Juvista when given once at time of
  surgery at 50 or 200ng/100?L/linear cm wound
  margin is inadequate in Breast Augmentation
• Favourable safety profile AEs and tolerability

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Large Phase 2 Programme provides Significant
Learning Confirming Opportunities

• Optimisation of drug efficacy under different
  dosing regimes
• Learning about trial design in this new
  therapeutic area of scar reduction
• To support our claim for a broad general label
• large scar reduction market remains accessible to
  Juvista
• currently evaluating options

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Juvista Data From Comprehensive Renovo Clinical
Trials Programme Experience for Phase 3

• Dose range established 200ng and 500ng most
  efficacious
• Dosing at time of surgery after wound closure and
  24 hours later best
• In patients and volunteers
• In young and old people
• In males and females
• In different skin types/colours
• In short and long scars
• In good and poor scars
• In incisions and excisions
• In different parts of the body
• Early and long term improvement in scar
  appearance
• Demonstrated by multiple different measures of
  scar improvement
• Reproducible in similar clinical trials
• With drug substance manufactured at PhIII and
  commercial scale

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Juvista Data From Comprehensive Renovo Clinical
Trials Programme Experience for Phase 3

• Safety and Tolerability
• Favourable profile
• AEs
• Tolerability
• Trial Design
• Knowledge of different clinical trial models
• Clinical variation understood in order to power
  Phase 3
• Within patient control

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Juvista Future Plans

• Renovo plans to commence the first European Phase
  3 trial in scar revision surgery in H2 2008
• Likely Phase 3 trial design
• evaluation of two doses of Juvista (200ng and
  500ng)
• given twice, once at the time of surgery
  following wound closure and once 24 hours later
• will use appropriately powered sample size
  calculated from 1009
• Renovo will provide further guidance on the
  design of this trial and the remainder of the
  Phase 3 programme following consultation with the
  regulatory authorities and Shire

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Rest of Pipeline

• Firm financial position with a net cash position
  as at 31 December 2007 of 93.8m
• Broad portfolio of drugs with different
  mechanisms of action
• Zesteem recruiting first Phase 3 trial which is
  on track to report in H2 2008
• Prevascar starting Phase 2 trial in nerve repair
  this year
• Juvidex recently commenced Phase 2 trial in
  acceleration of healing
• Deep preclinical pipeline

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APPENDIX
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Placebo scored better by lay panel but little
difference
Placebo
Juvista
SRN 10103
29
Placebo scored better by lay panel but little
difference
Placebo
Juvista
SRN 10104
30
Placebo scored better by lay panel but little
difference
Placebo
Juvista
SRN 10105
31
Placebo scored better by lay panel but little
difference
Juvista
Placebo
SRN 10106
32
Placebo scored better by lay panel but little
difference
Juvista
Placebo
SRN 10107
33
Placebo scored better by lay panel but little
difference
Juvista
Placebo
SRN 10109
34
Placebo scored better by lay panel but little
difference
Juvista
Placebo
SRN 10122
35
Placebo scored better by lay panel but little
difference
Placebo
Juvista
SRN 10126
36
Investigator VAS (On the Patient) Dosing pre
24hours post incision
50ng/100?L
5ng/100?L

200ng/100?L
500ng/100?L


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? Investigator VAS