2. What a bCA really is

3. European DCp
AW covered countries
ST covered countries

4. Bowel cleansing agents

5. A6B market Worldwide IMS Class A6B Bowel Cleanser global WW:
Value ex-factory EUR (.000)
IMS data MAT Q4 from 2011 to 2015
Source: IMS Analytic link

6. A6B market Worldwide IMS Class A6B Bowel Cleanser global WW:
Value ex-factory EUR (.000)
IMS data MAT Q4 from 2011 to 2015
Source: IMS Analytic link

7. A6B top Brand M.S. Value % global WW
A6B market Worldwide
A6B top Brand M.S. Value % global WW
Moviprep: PEG+ASC (2L+1)
Pico-Salax: Picosulphate/magnesium citrate (300 ml + 2)*
Fleet: Sodium phosphate (800ml + water)**
Fortrans: PEG-ELs (4L)
Citrafleet: Picosulphate/magnesium citrate (300ml + water)***
Gavilyte: PEG-ELs + Bisacodyle (2L)
Visicol: Sodium phosphate (20 tbs)
Niflec: PEG-ELs (4L)
Klean Prep: PEG-ELs (4L)
Source: IMS Analytic link
*150 ml ml + 2L of clear liquids after each glass of solution sachets)
** 45ml Fleet+ 360 of water + 45ml Fleet of water + as much water as you can
***150ml + 150ml + 250ml of water each hour

8. PEG + ASC Aspartame Main competitor NO Simethicone
Source: IMS Analytic link

9. A6B market worlwide
Source: IMS Analytic link

10. Open access system – a safety issue
Most patients meet the
endoscopist only for the exam
C.U.P.
Centro Unico Prenotazioni
Booking
Instructions

11. imethicone
itrate
PEG

12. Built to lead BCAs market

13. The ideal bca The ideal BCA should be:
EFFECTIVE: it should empty the colon of all fecal material (1)
SAFE: it should not cause shifts in fluids or electrolytes (1)
ACCURATE in the DIAGNOSIS: it should not cause gross or histological alteration of the colonic mucosa (1)
WELL TOLERATED: it should not cause discomfort (1)
WELL ACCEPTED: determinant factor for screening and surveillance (2)
Saltzman JR et al. Gastrointest Endosc 2015;81(4):781-94;
McLachlan SA et al. Patient Educ and Couns 2012;86(2):137-46

14. Recommendations and suggestions
ESGE and ASGE achieve consensus on
PEG-ELs SOLUTIONS
ADDITION OF SIMETHICONE
AGAINST SODIUM PHOSPHATE (NaP)

15. The ideal product for bowel cleansing! PEG + + itrate
imethicone
itrate
Efficacy & Safety guaranteed.
CLENSIA has it!
Suggested by guideline. CLENSIA has it!
Increase palatability. CLENSIA has it!
The ideal product
for bowel cleansing!

16. claim
2L+1
A combination of efficacy, safety and compliance for high quality colonoscopy guaranteed.

17. The creation of the brand
RESEARCH
CLEANNESS
BOWEL CLEANSING AGENTS
RESPECT
VISION
PERFORMANCE

18. “Efficacy, Safety and Compliance”
Rationale
New Bowel Cleansing Agent is an improvement on the market
First low volume medicinal product with PEG + Simethicone
Further to have same efficacy and same safety to the standard bowel cleansing agent, it provides a:
Reduced volume of solution
Better palatability, thanks to citrate presence
Better compliance
Product able to answer to patients’ and doctors’ need
Improvement of standard preparation
Best product for bowel cleansing
“Efficacy, Safety and Compliance”

19. Brand name analysis Phonetics Morphology Easy to pronounce
Set of consonants [clns] starts with a strong and incisive sound, but it is followed by a soft and delicate one:
The [l] softens the sound expressing sweetness
The nasal [n] gives color and roundness
The sibilant [s] provides a more delicate sound
Set of vowels [eia] is diversified:
[e] and [i] express accuracy and speed
The final [a] gives a sense of opening
Overall, melody results to be decisive, enchanting and delicate
“Clensia” sounds liquid
Clensia is a singular neologism of feminine origin that arises from an alteration of verb «cleanse»
It comes from archaic english clᴂnsian, clᴂne
These comes from germanic klainson, klainoz «clear, pure, limpid»
Clensia evokes also the verb “see” that reminds to the concept of visualization

20. IS AT LEAST EQUIVALENT to the COMPETITORS
CLINICAL EVIDENCE
2 REGISTRATIVE STUDIES
vs 4L PEG-ELs
vs 2L PEG- ASC
IS AT LEAST EQUIVALENT to the COMPETITORS

21. is as effective as Control
Bowel cleansing
is as effective as Control
Control
Control = 4L PEG-ELs
Other efficacy variables
With reference to the other efficacy variables EASYGOL did not differ significantly from PEG-ELs in terms of completeness of colonoscopy, time to reach the caecum, and withdrawal time.
Data on file, only for internal use

22. Mucosa visibility is similar to Control Control Control = 4L PEG-ELs
Data on file, only for internal use

23. Tolerability is better than Control Control Control = 4L PEG-ELs
Safety: No subject discontinued the study due to AEs. Occurrence of AEs was 8% after EASYGOL and 7.2% after Control. No SAE occurred. The rate of patients with at least one laboratory abnormal parameter decreased from screening after EASYGOL and after Control.
EASYGOL and Control resulted to be safe.
Tolerability: EASYGOL was significantly better tolerated than Control. Frequency of the overall GI symptoms (abdominal pain, anal irritation, bloating or nausea) was higher in the control group (37%) than in the study group (EASYGOL) (25.4%) (p<0.01).
Data on file, only for internal use

24. Acceptance and compliance
is better accepted than Control
Patient’s Acceptance
Patient’s Compliance
Control
Control
Control = 4L PEG-ELs
Data on file, only for internal use

25. is as effective as Control
Bowel cleansing
is as effective as Control
Control
Control = PEG-ASC
Split dosage was superior to full-dose schedule for both groups.
The examination was completed in 94.8 % of patients in EASYGOL group and in 96.4% of the Control group.
Elab. from Kump PK et al. Digestive Disease Week 2012; abstract Su1273

26. Mucosa visibility is similar to Control Control Control = PEG-ASC
Elab. from Kump PK et al. Digestive Disease Week 2012; abstract Su1273

27. CASE HISTORY

28. Previous colorectal resection
studies
2011
2012
2013
2014
2015
IBD pts
Launch
Repici
vs PEG-ASC
Cesaro
day before
vs same day
vs PEG-ELs 4L
De Leone
same day
vs PEG-ELs 4L split
Valiante
split
vs PEG-ELs split
Manes
vs PEG-ELs 4L
Mussetto
vs PEG-ELs + sim
Parente
split
vs PEG-ELs 4L split
Laghi
1L + Lopadimol
vs Lopadimol alone
Previous colorectal resection
In all clinical trials, bisacodyle is associated with the intake of LOVOL-esse Laghi_ use CT colonography.

29. Value ex-factory and M.S. The first 24 months
Units and M.S.
The first 24 months
Source: IMF sell-out pharmacy

30. Value ex-factory and M.S.
From launch up to now
Units and M.S.
From launch up to now

31. Looking ahead