1. Hexvix®/Cysview®: A Novel, Unique Photodynamic Diagnostic Agent that Improves Lives for Patients with Bladder Cancer

2. 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
70% of the patients with Bladder cancer are Medicare beneficiaries.
References:
SEER stats Fact Sheet: Bladder, National Cancer institute SEER accessed June 2013

3. 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
From diagnosis to death per patient ranging from $96,000 - $187,000 in the US
NMIBC: Non-muscle invasive bladder cancer
CIS: Carcinoma in situ
TURBT: Transurethral resection of the bladder tumor
References:
Sylvester RJ et al. Eur Urol 2006; 49:
Babjuk M et al. Eur Urol 2011; 59:
Herr HW. J Urol 1999; 162:
Divrik RT et al. J Urol 2006; 175:
Adiyat KT et al. Urology 2010; 75:
Jocham D et al. J Urol 2005; 174:
Brausi M et al. Eur Urol 2002; 41:
Botteman MF et al. The health economics of bladder cancer: A comprehensive review of the published literature. Pharmaconomics. 2003; 21:

4. Hexvix Blue Light Cystoscopy Diagnosis of NMIBC
Definition of “clinical precision”? - Equipment is specialized.
Hexvix is equipment and drug. A mayor development and a great opportunity for the doctor – and society!

5. 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

6. 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
Detects 30% more patients with bladder cancer
References:
Schmidbauer J, Witjes F, Schmeller N, Donat R, Susani M, Marberger M. Improved detection of urothelial carcinoma in situ with hexaminolevulinate fluorescence cystoscopy. J Urol 2004; 171:
Grossman HB, Gomella L, Fradet Y et al. A phase III, multicenter comparison of hexaminolevulinate fluorescence cystoscopy and white light cystoscopy for the detection of superficial papillary lesions in patients with bladder cancer. J Urol 2007; 178:
Fradet  Y, Grossman HB, Gomella L et al. A comparison of hexaminolevulinate fluorescence cystoscopy and white light cystoscopy for the detection of carcinoma in situ in patients with bladder cancer: a phase III, multicenter study. J Urol 2007; 178:
Jocham D, Witjes F, Wagner S et al. Improved detection and treatment of bladder cancer using hexaminolevulinate imaging: a prospective, phase III multicenter study. J Urol 2005; 174:
Hermann GG, Mogensen K, Carlsson S, Marcussen N, Duun S. Fluorescence-guided transurethral resection of bladder tumours reduces bladder tumour recurrence due to less residual tumour tissue in Ta/T1 patients: a randomized two-centre study. BJU Int 2011; 108: E297-E303.
305:Stenzl A, Burger M, Fradet Y et al. Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients with nonmuscle invasive bladder cancer. J Urol 2010; 184:

7. 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
Hexvix blue-light cystoscopy
Trend towards less evasive muscle invasive disease.
References:
Grossman HB et al. Long-term reduction in bladder cancer recurrence with hexaminolevulinate enabled fluorescence cystoscopy. Abstract in preparation et al. J Urol 2012; 188: 58-62
Garfield S. et al. The cost-effectiveness of blue ligh cystoscopy in bladder cancer detection: United States projections based on clinical data showing 4.5 years of follow up after single hexaminolevulinate hydrochloride instillation et al. The Canadian J Urol 2013;20(2); April 2013

8. Hexvix Commercial Success To Date
Approved in EU and US
Patented through in most markets
~230,000 patients diagnosed with Hexvix to date
Included in European Urology guidelines as Standard of Care
Strict global price €410/$770
Broad reimbursement approval
Market shares range up to 70%
High growth potential ~ 500K procedures annually in US & EU
2012: ~35% market share in PHO Nordic territory 6 years after launch

9. 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