PhotoCure - Second Quarter Results 2003

Oslo, Norway, 19 August 2003... PhotoCure presents today its report for the second quarter ending 30 June 2003. Highlights from the report include:

 

 

• In May, Metvix® was launched in the UK. This was the product's second launch by Galderma S.A., PhotoCure's marketing partner outside the Nordic region. The launch was supported by a successful symposium for Metvix® at the 2003 World Congress on Cancers of the Skin (Seville, Spain).
• Galderma has established educational centres in Germany and the UK for dermatologists to be trained in the use of Metvix® treatment of pre-cancerous skin disorder (actinic keratosis, AK) and skin cancer (basal cell carcinoma, BCC).
• Marketing of Metvix® in the Nordic countries has reached a solid basis for growth as approximately 150 clinical centres now offers treatment with Metvix®. Procedure reimbursement is now obtained in Norway and in parts of Denmark.

• Regulatory approval obtained in Australia for the treatment of pre-cancerous skin disorder (AK) and skin cancer (BCC). With the highest frequency of sun-induced skin diseases in the world, Australia constitutes a large market opportunity for Metvix®;
• The US Food and Drug Administration (FDA) evaluation of the New Drug Application submitted for Metvix® for the treatment of skin cancer (BCC) progresses as an advisory committee meeting will be held on 10 September 2003. Metvix® is already deemed 'approvable' for treatment of pre-cancerous skin disorder (AK);
• Clinical study on immunosuppressed organ transplant patients shows 90% complete lesion response.

• Through a collaboration agreement, PhotoCure and Karl Storz GmbH (Tuttlingen, Germany) have agreed to apply for a combined marketing approval in the US for Hexvix® and Karl Storz' D-light system for detection of bladder cancer. Karl Storz' D light system is already approved in Europe.
• Clinical data from the two completed European phase III multi-centre trials were presented at a satellite symposium organised by PhotoCure at the Scandinavian congress for urologists (Bergen, Norway). The data highlighted that significantly more (30%) dangerous cancers (carcinoma in situ) are detected with Hexvix® compared to standard white light cystoscopy, and that Hexvix® would be an important tool for improved detection of bladder cancer. In addition, the trials show that Hexvix® leads to important changes in patient management, with clear benefits for the patients.
• PhotoCure's first Marketing Authorisation Application for Hexvix® was filed in Sweden in December 2002, as the first step in gaining pan European approval.

 

Commenting on today's results, Professor Vidar Hansson, President and CEO of PhotoCure, said: "Progress for Metvix® in Europe continues as acceptance of this innovative and effective treatment steadily increases. The development of Hexvix® is also progressing well. The recent agreement with Karl Storz means that we now have a strong medical device partner for Hexvix®, which is important for a marketing application in the US. Importantly, I am very pleased to report that PhotoCure has achieved its first quarterly profit in the 2nd quarter as a result of the milestone payment from Galderma."