CysviewTreatment for Diagnostic
Update: Cysview (hexaminolevulinate) Now FDA Approved - May 28, 2010
NDA Submitted for Hexvix
Photocure submits application for marketing approval for Hexvix in USA to the FDA
Oslo, Norway, 30 June 2009 --Photocure announces today that a New Drug Application (NDA) has been submitted to the US Health Authorities (FDA) to obtain approval for Hexvix for use in the detection of papillary bladder cancer using fluorescence cystoscopy.
The NDA includes clinical data from 1838 patients, comprising two recently completed clinical studies, one Phase III pivotal study in 789 patients from EU/US and a Phase III study performed in Denmark in 233 patients. The NDA includes analyses in patients with papillary bladder cancer from earlier Phase III studies. The pivotal Phase III study shows a significantly improved detection (p=0.001) of non-invasive papillary bladder cancer in fluorescence cystoscopy with Hexvix compared to standard cystoscopy followed by a significant reduction in recurrence at 9 months (p= 0.026). The results from the pivotal Phase III study are supported by the Danish Phase III study which showed similar reduction in recurrence. All studies in the documentation demonstrate that fluorescence cystoscopy using Hexvix significantly improves detection of papillary bladder cancer compared to standard white light cystoscopy.
Photocure, in collaboration with GE Healthcare, has had several meetings with the FDA, leading up to this submission and the results of the pivotal Phase III study have been presented to the FDA.
All Hexvix clinical studies have been conducted using endoscopy equipment from Karl Storz, which enables cystoscopy using both standard white light and the blue light necessary for fluorescence cystoscopy.
The Principal Investigator of the pivotal Phase III study, Professor H. Barton Grossman at MD Anderson Cancer Center comments:" There is a significant need to improve the detection of bladder cancer in the US population and to reduce the recurrence of this disease. Based on the recently published clinical data from this study Hexvix will be an important tool in improving detection and treatment of bladder cancer in the US market."
Kjetil Hestdal, President and CEO of Photocure comments: "The NDA submission is a very important step for Photocure. With these excellent clinical data included in the NDA, Photocure is looking forward to receiving FDAs view on the NDA."
Photocure ASA 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.
Photocure has two proprietary pharmaceutical products on the market: Metvix, for the treatment of sun-damaged skin and certain types of skin cancer, and Hexvix, for the diagnosis of bladder cancer. In addition, the company has developed a proprietary light source, the Aktilite® lamp, which is used in combination with the Metvix 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 and technologies. For more information about Photocure, visit our website at www.photocure.com
Photocure®, Metvix®, Hexvix® and Aktilite® are registered trademarks of Photocure ASA.
Bladder cancer is the fourth most commonly diagnosed malignancy in men and tenth among women. The recurrence rate for patients with non-invasive bladder cancer is 50-70%. Bladder cancer is one of the most expensive cancers to treat because of its combination of long survival and intensive and costly routine monitoring and treatment due to the recurrent nature of the disease.
For further information, contact:
President and CEO Kjetil Hestdal
Mobile<: +47 913 19 535
Office: +47 22 06 22 10
CFO Christian Fekete
Mobile: +47 916 42 938
Office: +47 22 06 22 10
Posted: July 2009
- Cysview (Hexaminolevulinate HCl) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer - June 2, 2010
- FDA has posted an Advisory Committee meeting with Photocure to discuss Hexvix NDA - November 23, 2009
- Photocure ASA (NO) - Hexvix has been granted priority review by the FDA - September 1, 2009
- FDA Requests More Information Related to Hexvix NDA - April 20, 2006