The last year has been a landmark year for PhotoCure ASA with the company making excellent progress in all areas of its business. Highlights include:
· Metvix® PDT. PhotoCure’s global development programme for its lead PDT (photodynamic therapy) agent Metvix® has advanced significantly over the last twelve months with two European Market Authorisation Applications (MAAs) being made. The first filing for the treatment of actinic keratosis (AK) took place in May 2000. The second MAA for “High Risk” basal cell carcinoma (BCC) was submitted in January 2001.
· Hexvix® PD. A Phase II clinical trial evaluating Hexvix® PD’s (photodiagnosis) ability to enhance the detection of bladder cancer was started in 4th quarter 2000
· Photochemical Internalisation. PhotoCure has established a new subsidiary PCI Biotech AS and has recruited an experienced management team to maximise the potential of this novel technology.
· Oslo Listing. An IPO on the Oslo Stock Exchange in May 2000 was accompanied by a share issue, which raised NOK 356.5 million.
· Solid Financial Position. Liquid funds totalled NOK 399.7 million and shareholders equity totalled NOK 357.4 million as at 31st December 2000. The company’s operating deficit in 2000 was as budgeted and amounted to NOK 66.8 million.
The year 2001 will see PhotoCure achieve a number of major milestones, which will play a pivotal role in the company’s ambition to create significant value from its world leading photoactivation technology. The key milestones that PhotoCure expects to deliver in the next twelve months are:
· Metvix® PDT. PhotoCure expects to gain its first approval for Metvix® PDT for the treatment of AK. On-going discussions with the regulatory authorities in Sweden indicate that this will happen medio 2001. Swedish Marketing authorisation for “High risk” BCC is expected later in the year. PhotoCure plans to file MAA for the rest of the EU through the Mutual Recognition Procedure during the year.
Outside Europe PhotoCure expects to file MAAs for AK in the US, Australia, New Zealand and Switzerland. Filings for “High Risk” BCC are planned in Australia, New Zealand and Switzerland.
· Hexvix® PD. The company expects to start phase III trials for the PD of bladder cancer in Europe and USA
· Benzvix®. PhotoCure plans to complete pre-clinical studies, in order to start the clinical development of Benzvix®, a new photosensitiser, which will be targeted at the diagnosis/treatment of cancers of the gastrointestinal tract.
· PCI Biotech AS plans to launch its first product for the life science research market based on this unique delivery technology.
The Full Year Report for 2000 is available on the following link: http://www.photocure.com
http://reports.huginonline.com/808420/86551.pdf
