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PhotoCure - First Quarter Results 2003

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Oslo, Norway, 13 May 2003... PhotoCure presents today its report for the first quarter ending 31 March 2003. Highlights from the report include:


Launch of Metvix® PDT in Germany and the UK by Galderma
  • In February, Metvix® PDT was launched in Germany. This was the product's first launch by Galderma S.A., PhotoCure's marketing partner outside the Nordic region. The launch was accompanied by a successful symposium for Metvix® PDT in Berlin, which was attended by 150 key dermatology opinion leaders.
  • In May, Galderma also launched Metvix® PDT in the UK. A similar symposium was held in Seville at the 2003 World Congress on Cancers of the Skin.
  • Galderma has established educational centres in Germany and the UK for dermatologists to be trained in the use of Metvix® PDT for the treatment of actinic keratosis (AK) and basal cell carcinoma (BCC)
 
 
Milestone Payment of Euro 2 million from Galderma
  • PhotoCure is to receive a milestone payment of Euro 2 million in the second quarter 2003 as the first commercial sales of Metvix® PDT in Germany and the UK are completed.
 
 
Commercial Opportunities for Metvix® PDT Expanding
  • Regulatory approval is obtained for Metvix® PDT in Australia for the treatment of AK - the nation with the highest incidence of sun-induced skin diseases in the world represents a very important market for Metvix® PDT.
  • New Drug Application (NDA) submitted to US Food and Drug Administration (FDA) for Metvix® PDT for the treatment of BCC. Metvix® PDT already 'approvable' for treating AK.
  • Phase III trials in early squamous cell carcinoma (Mb. Bowen) show Metvix® PDT more effective than standard treatments.
  • Marketing of Metvix® PDT in the Nordic countries is progressing. At present, a total of 208 light sources have been installed at 134 clinical centres.
  • Metvix® PDT is approved in 14 European countries and in Australia and New Zealand.
 
 
Positive Phase III Clinical Results for Hexvix®
  • PhotoCure's second European multi-centre phase III study of Hexvix® for the detection of bladder cancer is now completed. Investigators found that Hexvix® fluorescence cystoscopy improved their ability to detect bladder tumours in 78% of the patients.
  • These results build on the results of the first phase III trial, which showed that Hexvix® fluorescence cystoscopy identifies 30% more patients with bladder cancer compared to standard cystoscopy.
  • PhotoCure's first Marketing Authorisation Application for Hexvix® was filed in Sweden in December 2002, as the first step in a European application process.
  • Recently, clinical data for Hexvix® was presented at the American Urology Association's annual congress in Chicago, a congress that gathered 12,000 urologists. Presentations were made at two plenary sessions, which were well received by urologists.
 
 
Financial Position

  • Revenues totalled NOK 10.4 million, compared with NOK 3.7 million in the same period of 2002. Net loss for the period amounted to NOK 18.5 million, a significant improvement on the NOK 29.5 million reported in the first quarter of 2002. Liquid funds amounted to NOK 215.6 million as of 31 March 2003.
 


Commenting on today's results, Professor Vidar Hansson, PhotoCure's President and CEO, said: "The progress that we made so far during 2003 highlights PhotoCure's exciting potential. The sales of Metvix® PDT in the Nordic regions increases and we are pleased by the positive reactions to the launches by Galderma in Germany and the UK. The results that we have generated with Hexvix® following the completion of the second phase III study and the positive reception of the clinical data presented at the recent American Urology Association's annual congress also augur well for the commercial success of this new product."


The 1st quarter report is available at the following link:
The 1st quarter presentation is available at the following link:

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