CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused...
Transcript of CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused...
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CORPORATE OVERVIEW
Products to Diagnose and Treat Gastrointestinal Diseases Today
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WHO WE ARE
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OUR COMPANYAries Pharmaceuticals
Aries Pharmaceuticals Inc., a San Diego-based,
specialty pharmaceutical and medical device company,
is focused on developing and commercializing best in
class products in endoscopy and to treat
gastrointestinal diseases. We are a wholly owned
subsidiary of Aries Pharmaceuticals, Ltd., which is a
wholly owned Subsidiary of Cosmo Pharmaceuticals,
NV. Aries is in charge of the US distribution of the
Cosmo products.
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MEET OUR MANAGEMENT TEAM
Teri ChuppeVice President,
Controller
Mike WaltherVice President of Marketing
Blake BolandSenior Vice President of
Sales
Jon HeeChief
Commercial Officer
Tom JoycePresident and C.E.O
David KrieselExecutive
Director of Medical Affairs
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OUR PRODUCTSImproving healthcare with better endoscopy/gastrointestinal focused products
Eleview™, Aries’ anticipated first product
to market, is an injectable composition
intended for use in gastrointestinal
endoscopic procedures for submucosal lift
of polyps, adenomas, early stage cancers
or other mucosal lesions prior to excision.
Remimazolam is currently in phase III
development for procedural sedation with
recently announced positive phase III data
in patients undergoing colonoscopy. The
completion of the 2nd pivotal study in
Bronchoscopy patients is expected to be
completed in Q2 2017. In-licensed by
Cosmo Pharmaceuticals from PAION.
Rifamycin SV MMX is a pharmaceutical
product employing MMX® technology.
Aries recently announced positive phase III
data in travelers’ diarrhea and phase II
trials underway for IBS-D and
uncomplicated diverticulitis.
Methylene Blue MMX, also called
LumeBlue, is a novel application of
methylene blue, a coloring agent that is
used to stain the mucosa to discover
pre-cancerous lesions and polyps in the
colon. Aries recently announced phase III
data in the increase of adenoma
detection rate in colonoscopies
compared to standard of care.
LumeBlue®
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COSMO PHARMACEUTICALS, NVOur parent company
Cosmo (COPN:SW), a Dutch pharmaceutical and
medical device company founded in Italy, aims to
become a global leader in the market of optimized
therapies for selected gastrointestinal diseases
including Inflammatory Bowel Diseases (IBD), colon
infections and colon diagnosis. Cosmo’s proprietary
MMX® technology is at the core of the company’s
product pipeline.
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COSMO PHARMACEUTICALS, NV
• COPN:SW (SIX SWISS EX)
• Shares : 14,419 M
• Market Cap: 2.568B
• Revenue (ttm): 76.22M
• EBITDA: 32.25M
• Headquarters: Dublin, Ireland
• Employees: 201-500
• Founded: 1996
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TECHNOLOGY
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MMX® MULTI MATRIX TECHNOLOGY
• Allows the delivery of active pharmaceutical ingredients into the lumen of the colon through tablets in a delayed and controlled extent with the effect that the active pharmaceutical ingredients can be applied to the full length of the colon
• The tablets manufactured according to the MMX technology are coated with pH-resistant acrylic copolymers which delay the release until the tablet reaches the indicated intestinal location where the programmed dissolution begins
• That allows for protection of the active substances from adverse pH conditions and enzymatic presence in the upper digestive tracts
• The controlled release over the length of the colon not only simplifies the application for the patients but allows for the topical application of the active pharmaceutical ingredients to the whole bowel surface that is affected by inflammations
• This technology may also be used for other diseases affecting the colon and can be used as a platform for applications outside the colon where a controlled release is of importance
Cosmo develops a range of pharmaceutical product projects that are based on MMX® technology
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PRODUCT DEVELOPMENT
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OUR PRODUCTSImproving healthcare with better endoscopy/gastrointestinal focused products
LumeBlue®
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PRODUCT / CANDIDATE PHASE 1 PHASE 2 PHASE 3 APPROVED NEXT MILESTONE
Launch May 2017
NDA FilingJune 2017
NDA FilingSeptember 2017
Bronchoscopy Trial Completion 1H 2017
OUR PRODUCT PIPELINEImproving healthcare with better endoscopy/gastrointestinal-focused products
LumeBlue®
ZEMCOLO®
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METHYLENE BLUE MMX TO IMPROVE ADENOMA DETECTION RATE DURING COLONOSCOPY
LuMeBlue®
• Adenoma detection rates are a primary quality indicator for colonoscopy
• Methylene blue MMX is a locally-acting vital dye indicated for enhanced visualization of adenoma in patients undergoing colonoscopy
• Oral tablets with MMX technology allows targeted delivery to the colon
• Studied in a ‘one of a kind’ multicenter, placebo controlled trial with 1270 patients
– Endoscopy charter required HDWL
– Colonoscopies all recorded and centrally reviewed
– Lesions all rated by central histologist
• NDA submission anticipated June 2017
47.81%
56.29%
42%
44%
46%
48%
50%
52%
54%
56%
58%Proportion of Patients ≥1 Proven Adenoma / Carcinoma*
HDWL+PBO HDWL+MB 200 mg*Full Analysis SetHDWL = high definition white light; PBO = placebo; MB = methylene blue
P=0.0099
+18% Gain with MB
Phase 3 Data Highlights
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RIFAMYCIN SV MMX TO ADDRESS GI-TRACT INFECTIONSZEMCOLO®
• Systemic antibiotics may be associated with greater drug interactions, side effects, and bacterial resistance
• Rifamycin SV MMX is a broad-spectrum non-absorbed antibiotic with strong eradicating effect across a variety of common GI pathogens
• Oral tablets with MMX technology allows targeted delivery to the colon
• Studied in two phase 3 trials for the treatment of traveler’s diarrhea
• Rifamycin SV MMX vs. Placebo • Rifamycin SV MMX vs. Ciprofloxacin
• NDA submission anticipated September 2017
• Additional potential indications are under investigation
Phase 3 Data Highlights
Time to last unformed stoolRifamycin SV MMX vs. Placebo
Time to last unformed stoolRifamycin SV MMX vs. Ciprofloxacin
P=0.0018for non-inferiority
P=0.0008for superiority
ITT Population
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REMIMAZOLAM TO ADDRESS GI-TRACT INFECTIONS
• Current sedatives attempt to balance onset, duration of action, reversal potential, and potential adverse events
• Bundling for colonoscopy services creates an incentive for GI-directed procedural anesthesia
• Remimazolam is an IV benzodiazepine with more rapid onset/reversal than midazolam while not requiring anesthesiologist-monitoring like propofol
• Large phase 3 trial for colonoscopy sedation completed
• Remimazolam vs. placebo vs. midazolam• Safety study in ASA III/IV patients ongoing
• Additional phase 3 trial for bronchoscopy sedation underway
Phase 3 Data Highlights
Chi-squared test for dependency
25.2%
1.7%
91.3%
0%
20%
40%
60%
80%
100%
Success of Procedure*
Midazolam Placebo Remimazolam
*Requires all: completion of colonoscopy, no requirement for rescue sedative medication, no more than 5 doses of study medication with 15 minute window for placebo and remimazolam,
no more than 3 doses within 12 minute window for midazolam
P<0.0001 P<0.001
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MANUFACTURING
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MANUFACTURING
• Solid and liquid forms for oral administration (tablets, capsules, granules, powders, syrups, solutions and suspensions)
• Topical dosage form (solutions, emulsions, gels, creams, ointments and suppositories)
• Injectable forms by final sterilization (cartridge ampoules for local nerve anesthesia)
• A significant portion of the company’s production is focused on pharmaceuticals in solid forms. The manufacturing process is controlled with respect to the raw materials and process parameters as well as final product quality. The controls are conducted according to procedures which comply with the provisions of Good Manufacturing Practices (GMP).
• Furthermore, the FDA has certified Cosmo for the production of Lialda®/ Mezavant® and Uceris® / Cortiment® tablets for the US market
Cosmo produces Aries’ pharmaceuticals at the company's facilities in Lainate, Milan
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OVERVIEW
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ELEVIEW™ OVERVIEW
• Colored clear emulsion submucosal injectable composition
• Delivers an immediate and long-lasting submucosal cushion of optimal height and duration
• Methylene Blue contrast agent offers greater margin visibility and submucosal layer staining
• Potentially reduces risk of perforations, adverse events, and post-op complications
• Used with standard, commercially available endoscopic injection needle – no special apparatus or equipment
Designed to allow the endoscopist an easy and safe endoscopic procedure
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ELEVIEW™ OFFERS GREATER VISIBILITY OF MARGINS FOR IMPROVED PROCEDURAL VISIONImproved margin visualization decreases the risk of damaging the external muscular layer, which could lead to perforation
Inject to form a submucosal cushion of optimal height and duration
Cushions last up to 45 minutes facilitating an easy and safe resection procedure
Methylene blue provides detailed delineation of the lesion edges and stains the submucosa, facilitating identification of muscle injury and enhancing the postresection view.
Reconfigures to form a colored cushion that pushes the mucosa away from the submucosa
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THE COMPONENTS OF ELEVIEW™ ARE DESIGNED TO CREATE A BETTER CUSHION1,2
Transforms upon injection to occupy the interstitial space, for a cushion of optimal height
EleviewTM Instructions for Use. Aries Pharmaceuticals, Inc. September 2016. Data on file.
Material Function
Water for injection Solvent
Medium chain triglycerides Oil component
Poloxamer 188 Bulking-cushioning agent
Polyoxyl-15-hydrostearate Emulsifier
Sodium chloride Osmotic agent
Methylene blue Dye enhances visibility
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ELEVIEW™ HAS A LONG-LASTING CUSHION DURATION OF UP TO 45 MINUTESEleviewTM demonstrated better cushion forming ability and duration when compared to saline*
*In an ex vivo porcine gastric mucosa model
Cushion Height As a Function of Time for Eleview™ versus Normal Saline
-52.9
-2.4
-60
-50
-40
-30
-20
-10
0Normal Saline Eleview
Perc
enta
ge D
ecre
ase
50 10 15 20 25 30 35 40 450
2000400060008000
10,00012,00014,00016,00018,000
Time (minutes)
Cush
ion
Heig
ht (m
m)
Percentage Reduction in Cushion Height After 45 Minutes for Eleview™ versus Normal Saline
Eleview™
Saline
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MARKETING & SALES
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ELEVIEW™ BRAND GOAL
Establish Eleview™ as thesuperior submucosal
injection standard when performing GI endoscopic
resection procedures
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ELEVIEW™ LAUNCHING MAY 2017 IN THE USFDA approved in September 2015
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INTEGRATED LAUNCH PLATFORM
Advertising & Communication Strategy
Medical Conference & Events
Medical /Scientific Education
Access and Distribution
Multi-Channel, Multi-Customer Resourcing
Advocacy and Early Experience
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KEY STUDY FIND ELEVIEW™ EFFECTIVE AND SAFE
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NEXT STEPS
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WHAT’S NEXT
• List
Measurable Goals and Outcomes
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THANK YOU!