What a bCA really is

European DCp AW covered countries ST covered countries

Bowel cleansing agents

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

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

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 + 150 ml + 2L of clear liquids after each glass of solution sachets) ** 45ml Fleet+ 360 of water + 45ml Fleet + 360 of water + as much water as you can ***150ml + 150ml + 250ml of water each hour

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

A6B market worlwide Source: IMS Analytic link

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

imethicone itrate PEG

Built to lead BCAs market

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

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

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!

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

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

“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”

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

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

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

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

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

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

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

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

CASE HISTORY

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.

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

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

Looking ahead