Hexvix® granted EU approval for prefilled syringe product packaging

Published: 4 July 2016

**New Hexvix kit has an improved design providing healthcare professionals with a simplified and easy-to-use product.

Oslo, Norway, July 4, 2016: Photocure ASA (OSE: PHO), announces today that regulatory authorities in the EU have granted approval for an improved and more user-friendly packaging for Hexvix.**

Solvent for Hexvix is used to reconstitute the Hexvix powder and will now be presented in a prefilled syringe. By providing solvent for Hexvix in a prefilled syringe, one step in the current reconstitution of Hexvix powder is omitted. Previous market research among healthcare professionals has verified that the prefilled syringe will ease the reconstitution process of Hexvix prior to bladder instillation and blue light cystoscopy. The company plans to introduce the Hexvix packaging to the European market in 2017.

"This improvement will simplify the clinical use of Hexvix as the new kit will now contain all components necessary for the reconstitution prior to instillation of Hexvix into the bladder cancer patients. This improvement will simplify the use of Hexvix both in the current bladder cancer resection market segment as well as the future use of blue light cystoscopy with Hexvix in the bladder cancer surveillance outpatient setting", says Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.

About Hexvix®

Hexvix® (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 cystoscopy procedure using a blue-light enabled cystoscope. 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.

Hexvix® is the tradename in Europe and Cysview® in the U.S. and Canada.

About bladder cancer

Bladder cancer is the fifth most common cancer in men with more than 380 000 new cases annually and more than 150 0001 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. 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.

For further information, please contact:


President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: kh@photocure.no

CFO Erik Dahl
Tel: +47 450 55 000, Email: ed@photocure.no

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