Oslo, 27 February 2002.
PhotoCure ASA (Oslo Stock Exchange: PHO) presents today the report with the results for 2001. The main items of the report are:
- Metvix® approved
Metvix® PDT was approved in Sweden and later recognised in large parts of Europe. In February 2002, the product was also approved in New Zealand. Moreover, marketing authorisation applications for Metvix® have also been filed in the US, Australia and Switzerland.
- Marketing and cooperation agreement signed with Galderma S.A.
PhotoCure has given Galderma exclusive global marketing rights to both the Metvix® cream and PhotoCure's activating light sources outside of the Nordic region. As part of this agreement, PhotoCure will receive milestone payments and royalties, as well as payment for the production of the light sources and the Metvix® cream. The agreement also opens for cooperation in development of new indications.
- Hexvix® in clinical phase III studies
PhotoCure has started enrolment of patients both in a European and an American multicentre phase III study, designed to document the safety and efficacy of Hexvix® fluorescence cystoscopy for detection of bladder cancer. The results of these studies will constitute the critical clinical documentation for applications for international marketing authorisations.
- New indications
Promising data is achieved in a clinical pilot study for acne. Initial studies of patients with early stages of oesophagus cancer and colon cancer are about to start.
- Financially strong
Liquid assets amounted to NOK 305.2 million as of 31.12.2001, a reduction of NOK 94.5 million from 31.12.2000. In February 2002, PhotoCure received 12 million EURO (approximately NOK 93 million) from Galderma.
President and CEO Vidar Hansson, says in a comment to the results: "2001 has been an eventful year for PhotoCure and marks the transition from being a company exclusively focused on research and development to a company that also engages in commercial activities. Approval in most European countries and the global marketing and cooperation agreement with Galderma, the world's most dedicated company in dermatology, constitute the most important events in 2001. Hexvix®, for detection of bladder cancer, has made significant progresses in clinical development and is now in the final clinical stage in both Europe and the US. Moreover, there are possibilities for new indications for existing and new products."
The full report for 2001 and a presentation will be published on our website www.photocure.com under "Investors".
Accounts
Annual report
Presentation