Oslo, Norway, 18th June 2001. PhotoCure ASA announces that it has received European approval for an important patent regarding aminolevulinic acid (ALA) derivatives. The Company now has intellectual property coverage for its photodynamic therapy (PDT) cancer treatments, Metvix®, Hexvix® and Benzvix®, in all of its major pharmaceutical markets including Europe, U.S., Australia, New Zealand and Singapore.
The patent (No. 0820432) covers a number of ALA derivatives. It includes the active ingredient used in PhotoCure's first product, Metvixâ for certain types of skin cancer and those used in the Hexvix® and Benzvix® products that are being developed for internal cancers such as cancer of the bladder and of the gastro-intestinal tract.
Professor Vidar Hansson, PhotoCure's CEO said, "The European patent approval is an important milestone for the Company. It provides a significant commercial advantage in all of PhotoCure's most important markets".
Metvix® is a topical cream that is used in photodynamic therapy to treat basal cell carcinoma (BCC) and pre-malignant skin conditions such as actinic keratosis (AK). Metvix® has been studied in an extensive clinical trial programme in Europe, Australia and the U.S. and today, PhotoCure also announced that it received its first marketing authorisation in Sweden. This is the first EU member state to approve Metvix®; other EU authorisations are anticipated shortly through the 90 days mutual recognition procedure. Marketing authorisation applications have also been submitted in Australia and New Zealand and an NDA (new drug application) will be submitted in the United States by the end of the year.
The results from the clinical trials programme, in which over 2,000 patients were treated, demonstrated the safety and effectiveness of the Metvix® PDT treatment and highlighted certain advantages of Metvix® PDT relative to traditional therapies. In particular, Metvix® PDT provides superior cosmetic results and is a simple, non-invasive method of treatment.
The development of Hexvix® for the photochemical diagnosis of bladder cancer is progressing as planned and patient inclusion in a Phase II study has now been completed. Phase III studies will start later in 2001.