PhotoCure ASA - Commercialisation of Metvix®PDT in Europe on track
Commercialisation of Metvix®PDT
- The Metvix®PDT approval is recognised by 14 European countries and national marketing authorisations are now issued in Sweden, Norway, Denmark, Iceland, Germany, United Kingdom, Ireland, Luxembourg and New Zealand. In the 6 remaining countries, PhotoCure is awaiting the final approval.
- Commercialisation of Metvix®PDT in the Nordic countries is on track.
- Galderma, PhotoCure's exclusive marketing partner for Metvix®PDT, prepares for its launch in major pharmaceutical markets outside the Nordic region.
- Marketing authorisation application is pending in the US.
- Additional Phase III results strengthen claims for Metvix®PDT.
Hexvix® in Phase III Clinical Trials
- Hexvix® fluorescence cystoscopy to detect bladder cancer has now entered clinical Phase III trials in the US and Europe.
- The first results from these studies are expected during the 2nd half of 2002.
Benzvix® in Early Studies for New Indications
- Benzvix® is being developed as a product for photodiagnostics and photodynamic therapy (PDT) for lesions in the gastro-intestinal tract. Pilot studies on patients with pre-malignant lesions in the oesophagus and colon have been initiated.
Financial position
- Total expenses of NOK 36.6 million and a net loss of NOK 29.5 million for the three months ending 31 March 2002 were as expected. Liquid funds totalled NOK 358.2 million as of 31 March 2002.
Commenting on PhotoCure's 1st quarter results, Professor Vidar Hansson, the Company's President and CEO, said: "The positive progress that we have made in the early part of 2002 suggests that this year will be as successful for PhotoCure as 2001 was. We are looking forward to several launches of Metvix®PDT following the marketing approvals that have been granted in a number of EU countries and New Zealand. Moreover, our other products are entering exciting stages of development, particularly Hexvix ®, which is now in an extensive international Phase III trial program for diagnosing bladder cancer."
The full quarterly report is available on our web site www.photocure.com under "Investors"/"Reports"/"Quarterly reports".
Report 1Q02
Presentation