Results from a large German study show that BLC with Hexvix® significantly improves detection of NMIBC

Photocure ASA announced today that data from the OPTIC III study: Optimized photodynamic diagnosis for transurethral resection of the bladder tumor (TURBT) in German clinical practice, is now available online in the World Journal of Urology: http://link.springer.com/article/10.1007/s00345-016-1925-0

The results of this large 30 center study demonstrate that Blue Light Cystoscopy (BLC) with Hexvix significantly improves the detection of NMIBC versus the standard procedure of white light (WLC) alone in routine clinical practice in Germany.

"This multicenter, prospective, non-interventional 403 patient study from 30 German inpatient surgical centers is an unprecedented assessment of the additional detection of cancer lesions with BLC with Hexvix versus WLC alone. Data from randomized clinical studies clearly demonstrates the benefit of BLC with Hexvix, especially in high risk cases. It now is encouraging to see the growing body of evidence supporting such benefit in routine clinical practice in line with current guideline recommendations," said Professor Dr. Maximillian Burger, Chair of Urology of the University of Regensburg, Germany.

"We are excited to see the addition of more real world data which continues to support the advantages of BLC with Hexvix. These real life data demonstrating the benefit of Hexvix/Cysview in a routine clinical setting highlight the significant value of Hexvix/Cysview, support the strong data delivered in randomized clinical trials and the inclusion in significant guidelines. As more urologists are exposed to the continued flow of data with Hexvix, we will continue to see even more patients having access to its substantive benefits," commented Kjetil Hestdal, MD, PhD, President and CEO, Photocure ASA.

Ipsen Pharma is strategic partner for Hexvix® in Europe excluding the Nordic region, and accountable for marketing in Germany. The OPTIC study was sponsored by Ipsen Pharma.

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 disease1. 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 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 20122. 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.

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. NMIBC is still in the inner layer of cells. These cancers are the most common (75%) of all bladder cancer 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.

About Hexvix®/Cysview®

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® is the tradename in Europe, Cysview® in U.S. and Canada. Hexvix® is marketed and sold by Photocure in the Nordic countries and in the US with the trade name Cysview®. Photocure has a strategic partnership with Ipsen for the commercialization of Hexvix in Europe, excluding the Nordic region. Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners
for further information on our commercial partners.