Earnings Release • Mar 14, 2016
Earnings Release
Open in ViewerOpens in native device viewer
Photocure ASA Hexvix® data presented during the European Association of Urology congress
Hexvix real world evidence show improved recurrence free survival and health
care savings
Oslo, Norway, 14 March 2016: Photocure ASA (OSE: PHO), a specialty
pharmaceutical company focused on photodynamic technologies in dermatology and
cancer, is pleased to announce presentations by urology researchers on Hexvix
during the European Association of Urology (EAU) annual meeting held in Munich,
Germany 11-15 March 2016. The EAU is one of the largest International meetings
in urology, showcasing the latest and most relevant knowledge with more than
12,000 urologists and exhibitors from over 100 countries. Hexvix is a
photosensitizing agent taken up selectively by the tumor cells in the bladder
that when exposed to blue light during a cystoscopic procedure results in a
bright pink fluorescence of the suspicious tissue. Using Hexvix as an adjunct
to standard white light cystoscopy enables the urologist to better detect and
remove lesions, leading to a reduced risk of recurrence.
Dr. Kjetil Hestdal, President & CEO of Photocure ASA comments: "We are
delighted to see the expanding body of evidence supporting Hexvix and its role
in the detection and management of bladder cancer. Real world data now
demonstrates the clinical and health economic benefits of Hexvix in a day-to-day
clinic setting supporting its widespread use. As more urologists are exposed to
the continued flow of data with Hexvix, more patients will have access to its
substantive benefits."
The Hexvix evidence from theory with its unique mode of action, randomized
clinical trials, and real world evidence were presented by Professor Dr.
Maximillian Burger, Chair of Urology of the University of Regensburg during a
symposium "Moving Forward in Urological Cancers" sponsored by Ipsen Uro-
oncology, strategic commercialization partner for Hexvix in Europe, excluding
the Nordic region.
Burger highlighted that bladder cancer is often under recognized and
undertreated. Despite the large majority of the audience voting that they
follow the guidelines he stated that there is still room for improvement. He
concluded that "Hexvix has been proven to offer significant benefits in the
detection and reduction in recurrence rates and emerging real world evidence now
confirms these findings, and even indicates better patient outcomes- especially
in high risk non-muscle invasive bladder cancer (NMIBC) patients, where it
matters most. The strong real world data can give us even more confidence
managing patients in our daily clinical practice. It improves recurrence free
survival and there are significant savings to the health care system as every
third follow up TURB can be avoided."
Hexvix is recommended for use in the diagnosis and management of NMIBC patients
in the EAU guidelines, NICE guidelines as well as a number of country specific
guidelines across Europe. The EAU guidelines for the management of non-muscle
invasive bladder cancer (NMIBC) have been developed after thorough assessment of
all clinical, safety and outcomes evidence to provide recommendations on the
best practice for managing these patients, from diagnosis through treatment.
However, there is currently considerable variability across Europe with
adherence to EAU guidelines, as reported in a poster presentation by Dr. E. N.
Xylinas, Cochin Hospital, Paris Descartes University. "Improved adherence to the
EAU guidelines on the management of patients with NMIBC would ensure all
patients across Europe have access and may benefit from the optimal methods for
detecting and managing the disease like Hexvix Blue-Light cystoscopy" concludes
Dr. Xylinas.
For further information, please contact:
Kjetil Hestdal
President and CEO
Photocure ASA
Tel. +47 913 19 535
About Photocure ASA
Photocure ASA, headquartered in Oslo, Norway, is a specialty pharmaceutical
company and world leader in photodynamic technology. Based on our unique
propriety Photocure Technology® platform, Photocure develops and commercializes
highly selective and effective solutions in disease areas with high unmet
medical needs such as bladder cancer, HPV and precancerous cervical lesions,
colorectal cancer and skin conditions. Our aim is to provide solutions that can
improve health outcomes for patients worldwide. Photocure is listed on the
stock exchange (OSE: PHO). Information about Photocure is available at
www.photocure.com
About Hexvix®/Cysview®(USA name)
Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an innovative
breakthrough technology in the diagnosis and management of non-muscle-invasive
bladder cancer. It is designed to selectively target malignant cells in the
bladder and induce fluorescence during a cystoscopic procedure using a blue
light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white
light cystoscopy enables the urologist to better detect and remove lesions,
leading to a reduced risk of recurrence. Hexvix®/Cysview® is approved in Europe,
USA and Canada.
About bladder cancer
Bladder cancer is the fifth most common cancer in men with more than 330 000 new
cases annually and more than 130 000 die of the disease. It has a high
recurrence rate with an average of 61% in one year and 78% over five years,
making the lifetime costs of managing bladder cancer one of the highest amongst
all cancers. It is a costly, potentially progressive disease for which patients
have to undergo multiple surveillance cystoscopies because of the high risk of
recurrence. A recent paper on the economic burden of bladder cancer across the
European Union estimates that bladder cancer cost the EU 4,9 billion Euro in
2012.There is an urgent need to improve both the diagnosis and the management of
bladder cancer for the benefit of patients and healthcare systems alike.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1993923]
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.