Letter to shareholders
To the shareholders in PhotoCure ASA
Dear shareholder,
In light of this weeks articles about PhotoCure in the Norwegian press, we would like to clarify certain items relating to our first product Metvix®.
Metvix® is a novel medicinal product being developed for photodynamic therapy (PDT) of non-melanoma skin cancer and premalignant skin disorders. Metvix®, which is developed by PhotoCure based on research at the Norwegian Radium Hospital is tested or is being tested in a broad clinical investigational program involving 72 clinical centres on three continents on about 2000 patients. An application for marketing approval in Europe for actinic keratosis (AK) was filed in May 2000. We currently expect to file an application for marketing approval in Europe for so-called high risk BCC within the next twelve months.
It has been asserted in the Norwegian press that alternative treatment methods like surgery and cryotherapy provide equal results as Metvix®. In PhotoCures multinational phase III study we compared Metvix® PDT to the current standard treatment, cryotherapy (freezing of the lesions). The two treatments gave similar results in terms of removing the lesions, but Metvix® PDT resulted in superior cosmetic outcome. 74 % of patients, who had previously been treated with other treatments for AK preferred Metvix® PDT to cryotherapy. As many as 96 % of the doctors participating in the study judged that patients treated with Metvix® PDT had an excellent or good cosmetic outcome compared to 81 % for cryotherapy. Our studies for BCC and high risk BCC show equally satisfactory results. We believe that cosmetic outcome is very important in this therapy because approximately 85 % of the lesions occur on the scalp or face.
The use of Metvix® PDT is a relatively simple procedure that can be performed on an outpatient basis. The treatment period is approximately 3 hours which for the patient primarily is waiting time and where the majority of the procedure can be carried out by auxiliary personnel. The Metvix® cream is selectively penetrating the cancer cells and has limited side effects. Results from a long-term study on patients with BCC documents that the risk of recurrence is 6 % for primary BCC after 3 years. The lesions showed normal skin regeneration without signs of local or systemic side effects.
We expect to obtain marketing approval for Metvix® in Europe in 2001. We intend to market Metvix® in the Nordic region through our own sales force and through one or more partnerships with other pharmaceutical companies outside this region.
We continue to believe that Metvix® will be an important advancement in the treatment of AK, BCC and high risk BCC, and we are investigating its use in other indications. These are large and growing markets and represent a major commercial opportunity for PhotoCure.
For announcements over the last 12 months, please see our website www.photocure.com.