Photocure ASA: CYSVIEW® GRANTED FDA APPROVAL OF NEW PREFILLED SYRINGE PRODUCT PACKAGING
New Cysview kit has an improved design providing healthcare professionals with an improved, simplified, and easy-to-use product.
Oslo, Norway, August 11, 2016: Photocure ASA (OSE: PHO), announces today that the U.S. Food & Drug Administration (FDA) has granted approval for an improved and more user-friendly packaging for Cysview. Regulatory approval in EU was granted in July 2016.
Diluent for Cysview is used to reconstitute the Cysview powder resulting in the Cysview solution. The diluent that is used to reconstitute the Cysview powder will now be provided in a prefilled syringe and in a needle free kit.
"This improvement is aligned with our mission to provide bladder cancer patients with access to treatments that improve their lives. The new Cysview kit will simplify the clinical use of Cysview both in the use of Blue Light Cystoscopy with Cysview during bladder cancer resection as well as the future launch of Cysview in the outpatient surveillance setting", says Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.
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 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.
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
About Photocure ASA
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology® 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, 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.
For further information, please contact:
Photocure
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
- Globocan. Incidence/mortality by population. Available at: ttp://globocan.iarc.fr/Pages/bar_pop_sel.aspx (accessed March 2015)
- 3. Leal et al, Eur Urol 2016; 69: 438-447