Oslo, May 29, 2010) Photocure (OSE: PHO), a Norwegian pharmaceutical company specialising in dermatology and cancer, today announces that the US Food and Drug Administration (FDA) has approved Cysview™, a fluorescence-based procedure for detection of papillary bladder cancer.
Photocure will now receive a 10 million milestone payment from GE Healthcare, its US licensee, and will be eligible for undisclosed royalties once the product has been launched. Cysview™ is already sold in 21 European countries and Korea under the brand name Hexvix® by Photocure and its licensee GE Healthcare.
Bladder cancer is the fourth most common type of cancer in men and the eighth most common in women in the US. More than 70,000 people in the US were diagnosed with cancer of the bladder in 2009, with an estimated 14,000 people dying from the disease, according to the National Cancer Institute. It is notoriously difficult to detect. The most common, initial sign is red-colored urine, which calls for urine cytology and cystoscopy.
Cysview™ cystoscopy is the first approved drug-device procedure for improved detection of bladder cancer. It is designed to induce fluorescence in the malignant cells in the bladder during a cystoscopic procedure, making it easier for the urologist to detect bladder cancer. It is the first product in a new diagnostic class known as photodynamic detection (PDD) agents. Cysview™ must be used with a blue light cystoscopy system from Karl Storz.
"The FDA approval of Cysview™ is a tribute to the patients and researchers who participated in our studies and is the culmination of nearly 10 years of research and development by our dedicated employees. It is a significant step towards realizing our mission of transforming the lives of patients with cancer." said Kjetil Hestdal, M.D. Ph.D., president and chief executive officer of Photocure.
He added: "The approval of Cysview™ is major milestone in Photocure's transformation into a sustainably profitable specialty pharmaceutical company and demonstrates our commitment to developing innovative products from our photodynamic technology platform."
"Data from the pivotal 305 trial demonstrates that Cysview™cystoscopy significantly improves detection of papillary bladder cancer, leading to more complete resection of bladder cancer and significantly improving disease-free survival when compared to white light cystoscopy," said Professor H. Barton Grossman, MD, professor Department of Urology at the M.D. Anderson Cancer Center in Houston, Texas, and the lead investigator of the trial.
Cysview™Clinical Trial Results Supporting FDA Approval
Photocure submitted the NDA on 30 June 2009 and achieved a Priority review scheduled to be completed by 30 December 2009. The NDA includes data from one pivotal and four supportive phase III studies. The pivotal phase III study included 814 patients and showed a significantly improved detection (p=0.001) of non-invasive papillary cancer using Cysview™ cystoscopy compared to standard white light cystoscopy in patients with non-invasive papillary bladder cancer. The improved detection was followed by a significant reduction (p= 0.026) in recurrence at 9 months. All the supportive Phase III studies confirmed the improved detection of bladder cancer using Cysview™.
About Bladder Cancer
Globally, bladder cancer is ranked 4th and 12th 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.
In the United States over 500,000 people are survivors of this cancer. Bladder cancer is four times more likely to be found in men than women.
Risk factors for bladder cancer include 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.
Most of the patients with bladder cancer need frequent follow up and treatment, some as often as 2-4 times per year. 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, www.cancer.org
National Cancer Institute, Surveillance Epidemiology and End Results, http://seer.cancer.gov
National Cancer Institute, Cancer Topics, Bladder Cancer, http://www.cancer.gov
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 to leading pharmaceutical companies 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 and in the US. 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 www.photocure.com.
Photocure®, the Photocure logo and Hexvix® are registered trademarks of Photocure ASA.
For further informPation, please contact:
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: firstname.lastname@example.org or email@example.com
Mary Clark, Anna Davies
Tel: +44 (0)20 7307 5330
This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)