Development on track
The global development of Metvix® and Curelight for the treatment of the pre-cancerous skin lesions actinic keratosis (AK) and the skin cancer basal cell carcinoma (BCC) is on track. The Marketing Authorisation Application (MAA) for Metvix® for the treatment of AK is currently under review by the Swedish authorities. The first response to this application from the Swedish Authorities is expected during November 2000. Patient recruitment for two phase III clinical studies for AK in Australia and U.S. has been completed and analysis of the response data from these studies will take place three months after final treatment. Two new phase III clinical studies evaluating Metvix® Photodynamic Therapy (PDT) for primary BCC have been initiated in Australia and USA and a phase III study for high risk BCC has also been started in Australia. Furthermore, clinical results from the Metvix® PDT clinical studies have been presented at a number of international scientific conferences. In addition, a phase III clinical study with Metvix® for Squamous cell carcinoma in situ (skin cancer) has been initiated. Clinical studies with Hexvixä have been initiated and a phase II clinical study with Hexvixä for bladder cancer detection is now underway. Total expenses amounted to NOK 51.6 million for the first 9 months of 2000 and are according to plans. Liquid funds totalled NOK 405.6 million as of 30th September 2000.
PhotoCure has completed its phase III AK clinical studies in Europe and a Marketing Authorisation Application (MAA) was filed with the Medicines Products Agency (MPA) in Sweden in May of this year. The first response to this application from the MPA is expected during November 2000. In order to supplement the clinical data included in the MAA for AK, the company has undertaken further clinical studies in the U.S. and Australia. Patient recruitment has been completed in two phase III clinical trials for AK: one in Australia and one in the U.S.. In these studies, which involved a total of 290 patients, Metvix® PDT was compared to placebo and/or cryotherapy. The first data from these studies are expected during first half of 2001.
A pivotal phase II clinical trial (final decisive study) for the treatment of high risk BCC is ongoing and response data after 12 months follow up are expected to be released in the 1st quarter of 2001. To support this indication further, PhotoCure has initiated a clinical study on high risk BCC in Australia. PhotoCure plans to file its first MAA for high risk BCC 1st quarter 2001.
Two phase III clinical studies for primary BCC are ongoing in Europe and the response data after three months follow up are expected to be released in early 2001. A total of 220 patients have been included in these studies which compare Metvix® PDT to cryotherapy and surgical excision. Further phase III clinical studies for primary BCC in Australia and USA have also been started.
Clinical data for Metvix® presented at scientific conferences
Data from the phase II and III Metvix® PDT studies have been presented at a number of scientific conferences. These conferences have included the 13th International Congress on PhotoBiology and 28th Annual Meeting of the American Society for Photobiology held in San Francisco July 2000, the Annual Meeting of the Norwegian Dermatology Society, held in Tromsø September 2000 and the European Academy of Dermatology and Venerology held in Geneva in October this year.
Clinical phase III study initiated for squamous cell carcinoma in situ
The company has initiated a phase III clinical study with Metvix® PDT for the treatment of squamous cell carcinoma (SCC) in situ, also called Bowens disease. SCC is a non-melanoma skin cancer that is about 3-4 times less frequent than BCC.
Clinical phase II study with Hexvixä for bladder cancer detection initiated
A phase II clinical study for detection of bladder cancer using Hexvixä and blue light to improve the cystoscopic procedure has started. A total of 50 patients will be recruited into this study, which will take place at five different clinical centres in Europe.
PCI Biotech AS established
PhotoCure has decided to establish a subsidiary for its new and patented transfection technologies in order to ensure the optimal development of products based on this technology platform. Dr. Andreas Grimeland has recently joined PhotoCure as the CEO of PCI Biotech AS.
Expenses as expected
Total operating expenses amounted to NOK 51.6 million for the first three quarters of 2000 compared to NOK 34.5 million in the first three quarters of 1999. The increase is mainly due to increased development activities, especially related to Metvix® PDT but also to Hexvixä photodiagnosis.
Shareholders equity totalled NOK 367.6 million as of 30th of September 2000 compared to NOK 81.4 million as of 30th of September 1999. Total liquidity amounted to NOK 405.6 million as of 30th September 2000 and is mainly invested in money market funds. The number of outstanding shares is 17.09 million as of 30th of September 2000.
The full report for the 3rd quarter 2000 including detailed financials figures is available on www.photocure.com, and on the following link: