Earnings Release • Sep 23, 2014
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Photocure: Expert consensus on the optimal use of Cysview® BLC published in Nature Reviews Urology
Cysview® improves detection of Non-Muscle Invasive Bladder Cancer (NMIBC) beyond
that achieved with current standard of care
Oslo, Norway, 23 September 2014: Photocure ASA (OSE: PHO), a specialty
pharmaceutical company focused on photodynamic technologies in dermatology and
cancer, is pleased to note that an expert consensus statement[1] on the optimal
use of Blue Light Cystoscopy with Cysview (HAL-BLC) in the United States has
been published in Nature Reviews Urology.
(http://www.nature.com/nrurol/journal/vaop/ncurrent/abs/nrurol.2014.245.html)
Blue Light Cystoscopy (BLC) with Cysview is an advancement in detection and
management of Non-Muscle Invasive Bladder Cancer (NMIBC) and is becoming
standard of care in many large institutions across the United States due to the
advantageous clinical benefit/risk ratio. Hexvix/Cysview has been used in
250 000 procedures to date, with consistent evidence that it improves detection
and management compared to White Light Cystoscopy (WLC) alone.
An expert panel of 16 American board certified Urologists and 1 European
Urologist reviewed existing published clinical evidence supporting the use of
Blue Light Cystoscopy with Cysview (HAL-BLC) for patients with NMIBC, including
European recommendations for its use and provided their own expert opinion on
which patients should receive HAL-BLC.
The panel proposed that the use of HAL-BLC in appropriate patient types will
result in better disease management, leading to potential reduced risk of
recurrence and prolonged time to recurrence. Improved detection and reduced risk
of recurrence is in turn associated with lower overall costs in managing bladder
cancer compared to WLC.
Dr. Sia Daneshmand, Director of Urologic Oncology and Associate Professor of
Urology at Institute of Urology, Norris Comprehensive Cancer Center at
University of Southern California and lead author, stated: "The consensus panel
recommendation outlines how urologists should incorporate HAL-BLC into their
clinical practice for the management of bladder cancer and the appropriate
patient types that would benefit from the technology. HAL-BLC results in a more
complete transurethral resection of bladder tumors (TURBT) and more accurate
staging, resulting in more appropriate management decisions. The evidence shows
not only reduced risk of recurrence but also prolonged time to recurrence."
Kjetil Hestdal, President and CEO of Photocure, said: "Bladder cancer affects
550,000 people in the U.S., with 74,690 newly diagnosed patients every year.
Approximately 15,580 patients die from the disease each year due to of
recurrence of the cancer. The consensus statement clearly outlines the benefits
of Blue Light Cystoscopy with Cysview and its positive impact on the diagnosis
and management of bladder cancer in multiple patient types. We believe the
adoption of HAL-BLC will bring significant benefit to urologists, patients and
payers fighting the disease."
The panel members also discussed key factors that must be considered for
incorporation of HAL-BLC into routine clinical practice in the United States,
including economic considerations and identification of stakeholders.
The consensus panel recommended that HAL-BLC should be considered
* For initial diagnosis of NMIBC
* For detection of recurrent tumors
* In patients with positive urine cytology but negative white light cystoscopy
(WLC) findings
* For optimal tumor staging
The panel concluded that extensive evidence and clinical experience show that
HAL-BLC can improve the detection of NMIBC beyond that achieved with the current
standard of care, WLC.
The consensus opinion of the US expert panel is in line with the opinions of
European colleagues, namely that HAL-BLC has a role in the initial diagnosis of
patients suspected to have NMIBC, as well as for management of recurrent bladder
cancer. The European Consensus publication "Witjes JA, et al. Clinical and Cost
Effectiveness of Hexaminolevulinate-guided Blue-light Cystoscopy: Evidence
Review and Updated Expert Recommendations. Eur Urol (2014)" can be viewed here.
For further information, please contact:
Photocure
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: [email protected]
CFO Erik Dahl
Tel: +47 50 55 000, Email: [email protected]
Hume Brophy
Mary Clark, Hollie Vile, Supriya Mathur
Tel: +44 20 3440 5653, Email: [email protected]
Notes to editors
About Photocure ASA
Photocure ASA, headquartered in Oslo Norway, is a specialty pharmaceutical
company and world leader in photodynamic technology. Based on our unique
proprietary Photocure Technology(TM) platform, Photocure develops and
commercializes highly selective and effective solutions within disease areas
with high unmet medical need, such as bladder cancer, HPV and precancerous
cervical lesions, colorectal cancer and skin conditions. Our aim is to provide
solutions which can improve health outcomes for patients worldwide. Photocure is
listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is
available at www.photocure.com.
--------------------------------------------------------------------------------
[1] Consensus Conference on Blue Light Cystoscopy with Cysview sponsored by
Photocure and KARL STORZ Endoscopy-America.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1857712]
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