Photocure received positive response from FDA on the New Drug Application (NDA) for Hexvix® for detection of bladder cancer

Published: 31 December 2009Medical InformationProduct Announcements

Oslo, Norway, December 31, 2009.

The Food and Drug Administration (FDA) has informed Photocure that the new drug application (NDA) for Hexvix for detection of non-invasive papillary bladder cancer may be approved pending approval of the PMA for the Karl Storz photodynamic diagnosis system and final agreements between Photocure and FDA on labeling, and post-marketing commitments. The photodynamic diagnosis system is the blue light cystoscopy system that will be used with Hexvix on the US market. Photocure expects the pending issues to be agreed with FDA within the first half year of 2010.

Hexaminolevulinate is marketed under the name Hexvix® in EU. The name to be used in US is currently being discussed with the FDA.

Photocure submitted the NDA on 30 June 2009 and achieved a priority review in August 2009. The NDA includes data from 1 pivotal and four supportive phase 3 studies. The pivotal phase 3 study in 814 patients showed a significantly improved detection (p=0.001) of non-invasive papillary bladder cancer using Hexvix cystoscopy compared to standard white light cystoscopy in patients with suspicion of non-invasive papillary bladder cancer. The improved detection was followed by a significant reduction (p= 0.026) in recurrence at 9 months. All supportive phase 3 studies confirmed the improved detection using Hexvix.

GE Healthcare licensed the global marketing and distribution rights for Hexvix from Photocure in 2006. Photocure will, according to the License Agreement with GE Healthcare, receive a milestone payment when the NDA and the PMA for the medical device is approved. The medical device is the blue light cystoscopy system from Karl Storz GmbH. This system is currently under a PMA review by FDA.

Kjetil Hestdal, President and CEO of Photocure comments “We are pleased that FDA acknowledge the medical need for improved detection of bladder cancer. We believe this new product will result in significant patient benefit in the diagnosis and management of bladder cancer. In Europe Hexvix has already been used by over 57, 000 patients since approval in 2005. We look forward to FDA’s approval and the subsequent launch by GE Healthcare on the US market.”

About Bladder Cancer

  • Globally, bladder cancer is ranked 4th and 8th in men and women respectively as the most common form of cancer causing mortality.  It is expected that the incidence of bladder cancer will continue to increase concurrent with an increase in industrialization, lifestyle factors and an aging population.  

  • Risk factors for bladder cancer include age, tobacco use, occupation (carcinogens in the workplace), infections, drinking arsenic-contaminated water, Caucasian race, male gender, family history, treatment with chemotherapy or radiation therapy, low fluid consumption and personal history of the disease.   

  • Over 500,000 people in the United States are survivors of this cancer. It is the fourth most frequent cancer diagnosed in men in the US. Bladder cancer is 4 times more likely to be found in men than women.  Many of the survivors need frequent follow up and treatment, some as often as 2-4 times per year. 

  • Recurrence following transurethral during the first year is estimated to range from 15 – 61% and within five years, 31 – 78 %.   

  • Common symptoms of bladder cancer include blood in the urine (making the urine slightly rusty to deep red), pain during urination, and frequent urination, or feeling the need to urinate without results.  


American Cancer Society, Key Statistics for Bladder Cancer,

National Cancer Institute, Surveillance Epidemiology and End Results,

National Cancer Institute, Cancer Topics, Bladder Cancer,

About Photocure

Photocure is a Norwegian pharmaceutical company listed on the Oslo Stock Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications.


Photocure's commercial activities includes own marketing and sales in selected markets as well as out-licensing on a regional or global basis prior to phase III.


Photocure has one proprietary pharmaceutical product on the market: Hexvix®, for the diagnosis of bladder cancer. Hexvix is approved in EU. In addition, the company has developed a proprietary light source, which is used in combination with the Visonac™ cream. Through worldwide studies, Photocure is continuously testing its products for new indications, and the aim is to develop a pipeline of follow-on products based on the Photocure Technology™platform.


For more information about Photocure, visit our website at


Photocure®, the Photocure logo and Hexvix® are registered trademarks of Photocure ASA.


For further information, contact:

Attn. Kjetil Hestdal (President and CEO) or Christian Fekete (CFO)

Kjetil Hestdal mobile +47 913 19 535 – Christian Fekete mobile +47 916 42 938

E-mail: or

This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)

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