Earnings Release • Dec 1, 2017
Earnings Release
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Photocure ASA: Blue Light Flexible Cystoscopy with Cysview® Phase 3 study: New data presented at Society of Urological Oncology
Oslo, Norway, December 1, 2017 Photocure ASA (OSE: PHO) announced today that
more detailed data from the Phase 3 study data was presented at the prestigious
Society of Urologic Oncology, Annual Meeting November 29 - December 01, 2017 in
Washington D.C., USA. Four separate posters were presented, including one using
patient reported outcomes (PRO) data from this study demonstrated the positive
impact of Cysview on patient Quality of Life.
The plenary presentation titled "Efficacy and Safety of Flexible Blue Light
Cystoscopy with Hexaminolevinulate (HAL) in the Surveillance of Bladder Cancer:
A Phase 3, comparative, Multi-Center Study" was presented by Dr. Siamak
Daneshmand, Associate Professor of Urology (Clinical Scholar), Director of
Urologic Oncology, at the University of Southern California Institute of Urology
and study investigator. As previously announced, results from the study showed a
highly statistically significant improvement (p <0.0001) in the detection of
patients with recurrence of bladder cancer using BLC((TM))with Cysview(®)with a
flexible cystoscope, compared to white light (WL) alone in patients with non-
muscle invasive bladder cancer (NMIBC).
In addition, an abstract on Patient Reported Outcomes was presented from the
same Phase 3 study which demonstrated a positive impact on anxiety. "Anxiety
decreased following flexible BLC with Cysview, and the majority of patients
(94%) undergoing this procedure found it worthwhile. Many Urologists
underestimate the impact of intense surveillance cystoscopy on the quality of
life and anxiety for patients with a bladder cancer diagnosis. These results
suggest that patients appreciate the extra confidence that BLC with Cysview
provides, which likely decreases their anxiety", says Dr. Angela B. Smith MD,
MS, FACS, Assistant Professor, University of North Carolina, Chapel Hill, North
Carolina.
"Photocure is delighted to see data supporting the use of Hexvix/Cysview with
flexible cystoscopy. The patient reported outcomes data adds a new level of
understanding of the patient experience of having bladder cancer and the
positive impact of BLC with Hexvix/Cysview on patient anxiety and confidence,"
says Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.
About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the
fourth most common cancer found in men in the US.(1,2,3) In 2016, it is
estimated that 76,960 new cases of bladder cancer will occur along with 16,390
deaths due to bladder cancer.
Bladder cancer is one of the most expensive cancers to manage, accounting for
approximately $3.7 billion in direct costs each year.(4,5 )
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall.( 2) NMIBC remains in the inner layer of cells
lining the bladder. These cancers are the most common (70%) of all BC cases and
include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when
the cancer has grown into deeper layers of the bladder wall. These cancers,
including subtypes T2, T3 and T4, are more likely to spread and are harder to
treat.( 2)
About Hexvix(®)/Cysview(®)
Hexvix(®)/Cysview(®) is a drug that is selectively taken up by cancer cells in
the bladder making them glow bright pink during Blue Light Cystoscopy (BLC(TM)).
BLC(TM) with Hexvix(®) /Cysview(®) improves the detection of tumors and leads to
more complete resection, less residual tumors and better management decisions.
Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all
other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US
and the Nordic region, and has strategic partnerships for the commercialization
of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer
to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further
information on our commercial partners.
About Photocure
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company
focusing on urology. Based on its unique proprietary Photocure Technology®
platform, Photocure is committed to developing and commercializing highly
selective and minimally invasive solutions to improve health outcomes for
patients worldwide. The company is listed on the Oslo Stock Exchange (OSE: PHO).
More information about Photocure is available at www.photocure.com,
www.hexvix.com, www.cysview.com
Company contacts:
Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Email: [email protected]
Erik Dahl, Chief Financial Officer
Tel: +47 450 55 000
Email: [email protected]
References:
1. SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute.
Bethesda, MD. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed April
2. Bladder Cancer. American Cancer
Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-
pdf.pdf. Accessed April 2016.
3. Hall M, Chang S, Dalbagni G et al. Guideline for the Management of Nonmuscle
Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 Update. J Urol.
2007;178(6):2314-2330.
4. Avritscher EB et al., Clinical model of lifetime cost of treating bladder
cancer and associated complications. Urology. 2006; 68:549-553.
5. Botteman et al. Clinical model of lifetime costs of treating bladder cancer:
a comprehensive review of the published literature. Pharmacoeconomics.
2003; 21:315-1330.
This information is subject to the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
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