PhotoCure ASA - Third Quarter Results 2002
Oslo, Norway, 6 November 2002.
PhotoCure presents today its report for the third quarter ending 30 September 2002. Highlights from the report include:
New Drug Application for Metvix® PDT Approvable in the US
- In September, PhotoCure received a letter from the FDA stating that the review of the New Drug Application (NDA) regarding Metvix® PDT for the treatment of actinic keratosis (AK) was completed and that the application was approvable.
- PhotoCure is planning to file a second NDA for Metvix® PDT in the US later this year for the treatment of Basal Cell Carcinoma (BCC).
Increase of Metvix® PDT Revenues
- Revenues in the third quarter of 2002 totalled NOK 7.7 million, compared to NOK 0.8 million for the same period in 2001 and NOK 4.6 million in the second quarter of 2002.
- Marketing of Metvix® PDT in the Nordic countries is progressing as planned. At present, a total of 161 light sources have been installed at 108 clinical centres. PhotoCure is targeting to have 150 centres established in the Nordic countries by May 2003.
- Galderma is finalising its preparations for the launch of Metvix® PDT in Germany in February 2003. This launch will be followed by the launch of Metvix® PDT in the UK.
- Metvix® PDT is approved in 14 European countries and in New Zealand.
Positive Phase III Clinical Results for Hexvix®
- PhotoCure's first multi-centre Phase III study of Hexvix® for the detection of bladder cancer is now completed. In this study, Hexvix® fluorescence cystoscopy detected almost 30% additional patients with CIS lesions, compared to standard white light cystoscopy. In addition, in a majority of patients with this type of cancer, more cancer lesions were found with Hexvix® than with white light cystoscopy.
- The first market authorisation application for Hexvix® is scheduled to be filed in Europe during the first half of 2003.
Patient Enrolment Ongoing in Pilot Study with Benzvix®
- Benzvix® is being developed as a product for photodiagnostics and photodynamic therapy for early lesions in the gastro-intestinal tract. Patient enrolment in the pilot study is progressing as planned.
- Operating revenues of NOK 7.7 million, total operating expenses of NOK 25.5 million and a net loss of NOK 17.2 million for the three months ending 30 September 2002 were as expected. Liquid funds totalled NOK 271.9 million as of 30 September 2002.
Commenting on today's results, Professor Vidar Hansson, PhotoCure's President and CEO, said: "The approvable letter from FDA for Metvix® PDT was a big event for PhotoCure, and we are now preparing the US application for treatment of BCC. In the Nordic countries, our sales revenues are starting to reflect the effort we have invested in Metvix® PDT training and the establishment of new treatment centres. Outside the Nordic region, we look forward to Galderma's launches in Germany and the UK."
Please find the presentation of 3rd quarter report on this link:
Please find full quarterly report at the following link: