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Hexvix®/Cysview®: A Novel,
Unique Photodynamic
Diagnostic Agent that
Improves Lives for
Patients with Bladder Cancer
Bladder Cancer Background
• Bladder cancer epidemiology (US):
– 5th most common cancer type
– 75,000 new cases in 2012
– 14,680 deaths in 2012
– >560,000 people living with
a diagnosis of bladder cancer
• 70% of patients are diagnosed with
Non-muscle invasive bladder cancer
(NMIBC)
– 70% Ta
– 20% T1
– 5 -10% CIS
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Medical Need to Improve Bladder Cancer Detection
• High risk of Recurrence of NMIBC
– Up to 61% at 1 year
– Up to 78% at 5 years
• Progression to muscle-invasive disease
– Up to 17% at 1 year
– Up to 45% at 5 years
– Common in patients with CIS, which are often difficult to detect
• High rate of residual tumor after TURB
– 34–76% of patients have evidence of tumor on repeat TURB at 2–6 weeks
• Patients with incomplete initial resection are at high risk of recurrence, which
may be due to:
– Continued growth of microscopic lesions which were not observed at initial TURB
– New growth of small residual traces of tumor, often at margins
• The highest cost of all cancers
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– From diagnosis to death per patient ranging from $96,000 - $187,000 in the US
Hexvix Blue Light Cystoscopy Diagnosis of NMIBC
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Hexvix;
- See what you have been missing
Standard White Light Cystoscopy
Hexvix Blue Light Cystoscopy
Bladder Cancer in a Different Light
Images supplied by Dirk Zaak, MD, University of Munich, Germany
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Hexvix Body of Clinical Evidence
• Hexvix has been extensively studied to investigate improvement in detection of
bladder tumors versus white-light cystoscopy
– 5 multi-center phase III trials in the USA, Canada and Europe
– >1,800 patients with known or suspected bladder cancer
• Hexvix cystoscopy:
– Significantly improves detection of papillary tumors in 16-29% of patients
– Significantly improves detection of patients with CIS tumors by 32%
– Detects 96% of all tumors
– Improves tumor resection
– Significantly reduces tumor recurrence
– Results in the more appropriate treatment compared to White Light
Cystoscopy
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Hexvix
Diagnostic Improvement Results in Better Outcomes
• A clinical trial in 551 patients,
demonstrates a significant improvement
in both short and long term bladder
cancer recurrence free survival
– Trend toward less progression and improved
bladder preservation
• Positive Resource Impact with Hexvix
– Hexvix patients cost 15% less over five years as
compared to white light patients Total average
cost per patient
• $30,581 white light , $25,921 Hexvix
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Hexvix blue-light
cystoscopy
Hexvix Commercial Success To Date
Units Sold, thousands
50
• Patented through 2019+ in most
markets
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• ~230,000 patients diagnosed with
Hexvix to date
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• Included in European Urology
guidelines as Standard of Care
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• Strict global price €410/$770
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• Broad reimbursement approval
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• Market shares range up to 70%
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• High growth potential ~ 500K
procedures annually in US & EU
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0
2006 2007 2008 2009 2010 2011 2012
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• Approved in EU and US
• 2012: ~35% market share in PHO
Nordic territory 6 years after launch
Photocure is actively searching for a partner to maximize
the commercialization of Hexvix in Selected Territories
Territories Available:
• Australia
• Canada
• Latin America
• Russia
Questions:
• Trude Tingvoll
Director Business Development & Alliance Management
+47 47 45 3313
[email protected]
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