Results 1st quarter 2001
- The planned commercialisation of Metvix® Photodynamic Therapy (PDT) remains on track. PhotoCure has now filed Marketing Authorisation Applications (MAAs) for Metvix® PDT for the treatment of pre-malignant actinic keratosis (AK) and 'high risk' basal cell carcinoma (skin cancer, BCC) in Sweden, Australia and New Zealand. Marketing Approval in the first EU country (Sweden) for both AK and 'high risk' BCC) is expected in mid 2001. Filing of MAAs in the remaining EU/EEA countries through the Mutual Recognition Procedure is scheduled in 3rd quarter 2001.
- Phase III results obtained in Australia have shown that Metvix® PDT is superior to cryotherapy in treating AK both in terms of efficacy and cosmetic outcome. In addition, European phase III results have shown that the efficacy of Metvix® PDT is similar with cryotherapy and surgery in treating BCC. However, Metvix® PDT gave superior cosmetic outcome.
- The development of Hexvix® for the photodiagnosis of bladder cancer is progressing as planned with patient recruitment now completed for the phase II study. Phase III studies are scheduled to start later in 2001.
- PCI Biotech AS has started development of its first product for the research market which is scheduled to be introduced early 2002.
- Total expenses of NOK 23 million and a net loss of NOK 14 million for the first three months of 2001 were according to plan. Liquid funds totalled NOK 380 million as of 31st of March 2001.
President and CEO Vidar Hansson commented on the first quarter results:
'We are pleased to report that our projects both in dermatology and urology are on track. Further, we enjoy the fact that we are approaching the first regulatory approval for Metvix® PDT. Focus is now on preparations for the launch, further regulatory filings for Metvix® PDT as well as preparations for the Hexvix® photodiagnosis phase III studies.'
PhotoCure ASA is a Norwegian listed company founded in 1993. PhotoCure ASA's mission is to develop and sell pharmaceuticals and medical devices based on proprietary photodynamic technologies. The company is developing products for skin cancer and other skin diseases, internal cancer, gene therapy and cancer vaccines. Metvix® and Curelight is developed for the treatment of basal cell carcinoma (skin cancer) and actinic keratosis (pre-cancerous skin lesions). PhotoCure's second pharmaceutical product, Hexvix®, is currently undergoing clinical trials for bladder cancer detection. PCI Biotech AS is established as a subsidiary of PhotoCure ASA to develop and commercialise new transfection technologies for the research market as well as products in oncology and gene therapy.
The full quarterly report and presentation is available on our web site www.photocure.com under Investor Relations.
For more information contact:
PhotoCure ASA
Attn. Vidar Hansson, CEO
Hoffsveien 48
0377 Oslo
Norway
www.photocure.com
E-mail: vh@photocure.no
Telephone: +47 22 06 22 10, Mobile: +47 90 73 78 72
Fax: +47 22 06 22 18