Cosmo Pharmaceuticals Nv · SIX:COPN
Cosmo Pharmaceuticals Nv — Baader Bank Conference 2017
68 slides from Cosmo Pharmaceuticals Nv's conference presentation, Jan 13, 2017
Slide 1: Baader Bank Conference
Baader Bank Conference Bad Ragaz January 13, 2017
Slide 2: Safe Harbour
Safe Harbour This presentation may include forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. The inclusion of forward-looking statements should not be regarded as a representation by Cosmo that any of its p
Slide 3: Cosmo The Tipping Point
Cosmo The Tipping Point e COSMO
Slide 4: Expanding the business from IBD to a one-stop shop for colonoscopies
4 Expanding the business from IBD to a one-stop shop for the colonoscopies mass market The pipeline fulfills three key objectives 1. See more and see better 2. Remove lesions safer and better 3. Make the procedure more efficient
Slide 5: LuMeBlue
LuMeBlue • Has successfully finished the phase III clinical trial • Has shown statistical superiority versus white light HD endoscopy • Full data released November 29, 2016
Slide 6: LuMeBlue
LuMeBlue • Allows Cosmo to enter a mass market • Fulfills unmet needs of endoscopists • Saves patients lives • Has no competition
Slide 7: The mass market of colonoscopies
7 The mass market of colonoscopies Every year: - 15 million colonoscopies are performed in USA - 17 million in Europe - Potential for 60 million in RoW
Slide 8: See more and see better
Clumesive Clumesiue 1.SEE MORE and SEE BETTER QCOSMO
Slide 9: Colonoscopy: standard of care
Colonoscopy: standard of care What is the highest current standard of care in colonoscopies ? High Definition White Light Colonoscopy (“HDWL”) Requires sophisticated HD equipment and it is used in less than 20% of overall procedures ISSUES Even if using the best available tools, the Adenoma Detectio
Slide 10: ADR varies across endoscopists
3 18 endoscopists 3 462 colonoscopies ADR of There is a need to Individual narrow the range endoscopists of ADR detection rates
Slide 11: The more patients with adenoma are detected
1 The more patients Risk of interval cancer by endoscopists with adenoma are with low ADR detected…. HR 10 95% CI 1.4-87 The more cancer is prevented Risk of interval cancer by endoscopists with high ADR
Slide 12: For each 1% increase in ADR: 3% decline in interval CRC
2 For each 1% increase in ADR: 3% decline in incidence of interval CRC 5% decline in incidence of fatal CRC
Slide 13: For every 5% improvement in ADR
•For every 5% improvement in ADR: •11% reduction in CRC incidence Every year in USA: (95%CI, 10.3-11.9) - 149,000 CRC cases - 50,000 CRC deaths •13% reduction in CRC death (95%CI, 11.1-13.7) - 14$ billion •-3% cost due to saving in CRC treatment
Slide 14: Chromoendoscopy
Chromoendoscopy According to the ASGE-ESGE, chromoendoscopy “is the topical application of stains or dyes at the time of endoscopy in an effort to enhance tissue characterization, differentiation, or diagnosis» Chromoendoscopy is recommended in IBD patients to enhance detection of neoplasias However
Slide 15: Improving the subjective skill of endoscopists in identifying dysplasia
15 Improving the subjective skill of endoscopists in identifying dysplasia
Slide 16: Introducing and going beyond HDWL
Introducing and going beyond HDWL
Slide 17: FLAGS
Significantly enhances ADR substantially beyond HDWL and FLAGS lesions in an previously unseen, unrivalled fashion
Slide 18: LuMeBlue
Cimestue
Slide 19: A one-of-a-kind trial
A one-of-a-kind trial In ordinary trials, placebo is generally water and sugar in our trial Placebo is the highest standard of care (HDWL) … performed and not only…. In some of the top hospitals by some of the top endoscopist in the world
Slide 20: A one-of-a-kind trial: Olympic champion example
A one-of-a-kind trial As an example It is as taking the performance of an Olympic champion and making it SIGNIFICANTLY BETTER Increase his performance on 100m from 9.63s to 8.19s ? Can we do it ?
Slide 21: LuMeBlue is a fully fledged drug
A one-of-a-kind trial LuMeBlue is not a medical device or a tool but a fully fledged drug. The LuMeBlue trial is the first multicenter and multinational trial in colonoscopy with extremely stringent requirements therefore raising the odds and hurdles but also the overall reliability of the result.
Slide 22: Primary and main secondary endpoints
A one-of-a-kind trial Primary Endpoint Main Secondary Endpoints Proportion of subjects with at least one As of efficacy histologically proven Adenoma or Carcinoma • False positive rate • Proportion of subjects with at least one histologically proven Adenoma As of safety • Adverse events • Renal and
Slide 23: Homogeneity between FAS and PP
A one-of-a-kind trial Extraordinary homogeneity between FAS and PP, showing very few deviations and therefore increasing overall data reliability. PP shows the real efficacy of the treatment without major deviations. A large deviation between FAS and PP may mean that results are influenced by factor
Slide 24: LuMeBlue significantly enhances ADR in FAS
LuMeBlue significantly enhances ADR in the full analysis set FAS HDWL 200 mg ADR 47.81% 56.29% Relative risk increase* 17.7% P-value 0.0099 Odds Ratio 1.41 [1.09, 1.81] *Calculated as (ADRLuMeBlue 200 mg / ADRHDWL) - 1
Slide 25: LuMeBlue False Positive Rate is better than HDWL
LuMeBlue False Positive Rate is >> better than HDWL The superiority of LuMeBlue False Positive Rate (FPR) versus HDWL was a critical request from Agencies. Agencies wanted to make sure that LuMeBlue was not enticing the endoscopist to remove lesions that would have subsequently not proven to be aden
Slide 26: LuMeBlue decreases FPR by 14.4% vs HDWL
LuMeBlue FPR is significantly better than HDWL Pts 356 Pts 326 LuMeBlue decreases FPR by 14,4% vs HDWL p-value: < 0,0001 FP 97 FP 83 Total LuMeBlue pts : 485 Total HDWL pts : 479 FPR LuMeBlue FPR HDWL 23,3% 29,7%
Slide 27: LuMeBlue is clinically more relevant in the most important segment
LuMeBlue is clinically more relevant than HDWL in the most important segment of patients If adenomas are detected during colonoscopy, the subject will be referred to a next colonoscopy in a short time span ie 1-3 years If no adenomas are detected during colonoscopy, the subject will be referred to a
Slide 28: LuMeBlue efficacy has high diagnostic value
LuMeBlue efficacy has high value diagnostic efficacy The Number of Excisions is one of the trial quality control parameters and has a very important meaning for a diagnostic treatment: lower the number of excisions, more difficult that a precancerous lesion could be positively detected in a patient.
Slide 29: Max diagnostic value increase in 0-1 excision segment
LuMeBlue shows max diagnostic value increase in the segment with 0 - 1 excision ADR IN OVERALL PTS POPULATION ADR IN PTS WITH EXCISION 0 - 1 HDWL 47.81 HDWL 18.94 LuMeBlue 56.29 LuMeBlue 26.18 RRI 17.7% RRI 38.2% 56.29 RRI 17.7 RRI 38.2 47.81 26.2 18.9 Pts 485 Pts 479 Pts 233 Pts 264 HDWL HDWL
Slide 30: LuMeBlue flags more subjects with proven adenoma
LuMeBlue flags more subjects with histologically proven adenoma (excluding carcinoma) than HDWL HDWL 200 mg Pts with histologically proven 220 268 adenoma Percentage overall population 45.93% 55.26% Relative risk increase* 20.3% P-value 0.0046 Odds Ratio 1.45 [1.13, 1.87] Data from FAS *Calculated a
Slide 31: LuMeBlue flags more non-polypoid lesions
LuMeBlue flags more subjects with non-polypoid lesions than HDWL HDWL 200 mg Overall pts Pts with non-polypoid lesions 168 213 273 Percentage overall population 35.07% 43.92% 56.29% Relative risk increase* 25.2% 15.1% P-value 0.0056 0.0099 Odds Ratio 1.45 1.41 [1.12, 1.88] [1.09, 1.81] Data from FAS
Slide 32: LuMeBlue flags more diminutive adenomas
LuMeBlue flags more diminutive adenomas than HDWL HDWL 200 mg Patients with diminutive 144 178 adenomas Percentage overall population 30.06% 36.70% Relative risk increase* 22.1% P-value 0.0342 Odds Ratio 1.35 [1.03, 1.76] Data from FAS *Calculated as (ADRLuMeBlue 200 mg / ADRHDWL) - 1
Slide 33: LuMeBlue development status
33 LuMeBlue Development status • Phase III completed, primary endpoint “proportion of subjects with at least one histologically proven Adenoma or Carcinoma” attained Timing • NDA Filing targeted for H1 2017 Business Development • Discussions for RoW licensing ongoing
Slide 34: Remove lesions safer and better
REMOVE LESIONS 2. SAFER and BETTER
Slide 35: The current standard: hand-made saline solution
35 The current standard: a hand-made saline solution application
Slide 36: See the difference with Eleview?
36 See the difference with Eleview ?
Slide 37: Eleview market potential from additional indications
37 Eleview market potential from additional indications The tissues of the esophagus, stomach and duodenum are similar to those of the colon Inspection of these conducted by Esophagogastroduodenoscopy (ECG) Eleview can be used in all these tracts As many ECGs are performed as colonoscopies, both in
Slide 38: Eleview
38 Eleview Development status • USA approved Marketing trials in four sites ongoing (speed and safety versus standard care in EMR) • EU Approved Timing • Targeted for launch in EU and USA in H1 2017 Business Development • Licensing process in EU and RoW ongoing
Slide 39: Make procedures more efficient
39 REMIMAZOLAM 3. MAKE PROCEDURES MORE EFFICIENT
Slide 40: Cost bundling in USA
40 Cost bundling in USA Incentive to make procedures as fast as possible Make them cheaper by reducing use of more costly personnel
Slide 41: Remimazolam
41 Remimazolam Procedural sedation is used in practically all colonoscopies in the USA Market is split ~50%: 50% between propofol and midazolam Targeted to save costs Phase II b clinical trial demonstrate 6 min reduction in sedation time (faster onset and faster wake up) than midazolam allowing time
Slide 42: Cosmo's pipeline goes beyond colonoscopies
42 Cosmo’s pipeline goes beyond colonoscopies After and expanding the unique position in GI
Slide 43: Zemcolo
2)Zemcolo
Slide 44: Project Rationale
44 Project Rationale Rifamycin SV is a well established, broad spectrum, low MMX™ tablets toxicity, semi-synthetic, antibiotic, approved and marketed for parenteral or topical use in some EU Countries for systemic or local infections control Oral administration does not cause appreciable blood serum
Slide 45: First indication: Travellers' Diarrhea
45 First indication: Travellers‘ Diarrhea Most frequent health problem in travellers to developping countries Often characterized by: • Abdominal cramps • Fecal urgency • Nausea / Vomiting • Fever Consequences: • immediate: • Incapacitation 30 - 45% of patients for 12 - 21 h [Steffen R et al. J Trav
Slide 46: Zemcolo: TD trials Phase III
46 Zemcolo: TD trials Phase III Two pivotal clinical trials were required to support registration: 1 – US trial (superiority vs. 2 – EU trial (noninferiority vs. Cypro) placebo) A randomised, double-blind, double-dummy, A Phase 3, Multicenter, Randomized, multi-centre, comparative parallel-group Dou
Slide 47: Zemcolo shows a TLUS clearly shorter than placebo
47 Zemcolo: TD trials Superiority vs placebo (Santarus) Zemcolo shows a Distributions of Time to Last Unformed Stool (ITT Population) TLUS clearly shorter than placebo
Slide 48: Superiority vs placebo: outcome
Zemcolo: TD trials Superiority vs placebo (Santarus) Outcome This is the first ever Results from this well- clinical trial in TD controlled Phase 3 against placebo where study demonstrate a the drug has clearly favorable benefit-to-risk shown a statistical profile for Zemcolo significance in clinica
Slide 49: Non-inferiority vs Cipro: trial design
49 Zemcolo: TD trials Non-inferiority vs Cipro (standard of care) (Falk) Outcome Objective: To prove the non-inferiority of Zemcolo versus Ciprofloxacin for the treatment of TD Number of subjects: Total enrolled: 835 Total completed: 814 Regions: India, Guatemala, Ecuador, Peru, Mexico Group A: 2 Ze
Slide 50: Non-inferiority vs Cipro: outcome
Zemcolo: Non-inferiority vs Cipro (standard of care) (Falk) Outcome Falk Santarus Ciprofloxacin Rifamycin SV-MMX Placebo Rifamycin SV-MMX (FAS n=415) (FAS=420) (ITT n=65) (ITT n=199) 352 (84.8%) 357 (85%) 37 (56.9%) 162 (81.4%) Zemcolo is as efficacious in treating TD patients as Cipro and clearly s
Slide 51: Microbial strain reduction vs Ciprofloxacin
Zemcolo: TD trials Non-inferiority vs Cipro (standard of care) (Falk) Outcome ZEMCOLO CIPROFLOXACIN Non-inferiority of Zemcolo Microbial Strain Baseline Final % reduct. Baseline Final % reduct. vs Ciprofloxacin in main Giardia lamblia # 45 # 19 57.8 # 34 # 15 55.9 microbial strain reduction Cryptosp
Slide 52: Non-inferiority vs Cipro: conclusions
Zemcolo: TD trials Non-inferiority vs Cipro (standard of care) (Falk) Outcome The study clearly showed non-inferiority of Zemcolo vs Ciprofloxacin in terms of time to last unformed stool in TD The secondary endpoints showed Zemcolo has similar efficacy vs Ciprofloxacin Zemcolo is a very safe d
Slide 53: Significant edge vs Cipro after FDA warning letter
Zemcolo: significant edge vs Cipro after FDA issued a WARNING LETTER to Cipro Ciprofloxacin, because of its systemic absortion, has severe side effects and has just received an FDA warning letter Zemcolo, because of its colonic delivery, has no systemic absorption, thus practically 53 no side effect
Slide 54: Zemcolo: the way forward
54 Zemcolo: the way forward 1 – Travellers’ diarrhea is the simplest way to prove the antinfective property in GI and requires short treatment 2 – Other indications will be advantageously pursued with this anti-infective, anti-inflammatory drug: IBS and diverticulitis 3 – IBS and diverticulitis requ
Slide 55: Clear edge vs Xifaxan in anti-inflammatory properties
55 Zemcolo: the way forward Clear edge vs Xifaxan in anti-inflammatory properties % inhibition of cytokines/ IL6 TNFα Rantes chemokines secretion Monocytic Cells 100 100 μM De 10 50 10 50 Dex 100 100 x 1 1 Dex 100 100 10 50 10 50 10 50 10 50 1 1 1 1 Rifamycin Rifamycin Rifaximin Rifamycin Rifaximin
Slide 56: Zemcolo: the way ahead
56 Zemcolo: the way ahead clear edge vs Xifaxan in anti-inflammatory properties Based on the EC50 values, Rifamycin SV is 100 times more potent than Rifampicin Rifamycin SV is at least 1000 times more potent than Rifaximin at stimulating PXR transcriptional activity in a cell line engineered to
Slide 57: Zemcolo: wrap-up
57 Zemcolo: wrap-up significantly reduces TLUS in TD TLUS was significantly shorter in Zemcolo compared to placebo showed non-inferiority vs Ciprofloxacin in terms of TLUS secondary endpoints showed similar efficacy vs Ciprofloxacin showed non-inferiority vs Xifaxan in TLUS and treatment s
Slide 58: Zemcolo: wrap-up versus competitors
58 Zemcolo: wrap-up In respect of potential competitors Compared to Xifaxan, Zemcolo allows antibiotic to be delivered directly to the colon, avoiding unwanted effects on the beneficial saprophytic bacterial flora living in the upper portions of the gastrointestinal tract Compared to Ciprofloxac
Slide 59: Zemcolo: wrap-up
59 Zemcolo: wrap-up Zemcolo provides an effective and innovative treatment option for colonic infections because It is a broad spectrum, semi-synthetic, orally non-absorbable antibiotic that can be used for the treatment of bacterial infections of the colon such as traveler’s diarrhea Antibiotic
Slide 60: Zemcolo Development Plan
Zemcolo Development Plan US (Cosmo) Travellers’ Diarrhoea To be extended to: IBS D Development Timeline: Phase II DR to start in Q3 16 EU (licensed to Dr. Falk) Travellers’ Diarrhoea To be extended to: Uncomplicated Diverticulitis Development Timeline: Phase II P.O.C. ongoing interim analysis in Jan
Slide 61: Addressing the full value proposition
Addressing the full value proposition Cosmo will directly market its products in the US with most efficient structure The value chain Research Development Manufacturing Marketing Sales
Slide 62: Capturing the entire value chain
Introducing A specialty pharmaceutical company focused on commercializing best in class products to treat gastrointestinal diseases Allowing Cosmo to capture the entire value chain Research Development Manufacturing Marketing Marketing Sales Sales
Slide 63: Aries Pharmaceuticals US structure
• Cosmo Pharmaceuticals NV has recently incorporated fully owned Aries Pharmaceuticals Ltd, Dublin • Aries Ltd is 100% holder of Aries Pharmaceuticals Inc., San Diego • Aries Ltd will market in the US under a license and supply agreement LuMeBlue, Eleview, Zemcolo and Remimazolam • Aries Pharmaceuti
Slide 64: US senior management team in San Diego
• Leveraging on existing fruitful relationships, Cosmo has hired a US senior highly experienced management team located in San Diego • Aries Inc. management team has a specific expertise in marketing and distribution of GI drugs and pharmaceuticals products • Aries Inc. management team is incentiviz
Slide 65: Aries Pharmaceuticals Inc. top management team
Introducing Aries Pharmaceuticals Inc. top management team Tom Joyce – President & CEO From 2004 to 2014 Vice President, Marketing and National Accounts at Santarus. From 2014 to 2016 founder and partner of L.A.S. Partners, a health science consulting company focused on providing commercial insight
Slide 66: Staffing Plan
Aries Inc. projected evolution of staff & salesforce according to preliminary marketing plans Staffing Plan 2016 2017 2018 2019 Total 22 87 179 259 Thereof hired 0 30 85 145 salespersons Additional salespersons 0 30 85 85 on contract (not included in total) Staffing may vary depending on launch timi
Slide 67: Set-up of new offices and IT infrastructure completed
Set-up of new offices and IT infrastructure completed Aries Inc. new offices in San Diego, Scranton road The Towers South 9276 Scranton Road Suite 600 San Diego, California 92121 T: +1 (858) 202 6122 [email protected] www.aries-pharma.com
Slide 68: Cosmo Pharmaceuticals Information Contacts
Cosmo Pharmaceuticals Information Contacts •Number of shares: 14,418,983 • Alessandro Della Cha , CEO [email protected] •Listing: SIX Swiss exchange, Main board • Luigi Moro, CSO [email protected] •ISIN: NL0011832936 • Niall Donnelly, CFO [email protected] • Giuseppe Cipriano, CO