Report for the 9 months period ended 30.9 1999
A total of more than 650 patients have so far received treatment with Metvix® in prospective clinical studies. As of end of October, PhotoCure has completed two clinical studies and another 11 clinical studies are now ongoing at a total of 50 leading research- and treatment centres in 12 European countries. These studies are performed in order to enable PhotoCure to file Market Authorisation applications for three different indications in Europe. These three indications are Actinic Keratosis (AK), Basal Cell Carcinoma (BCC) and High Risk BCC. The total documentation package is expected to position Metvix® as a novel and excellent treatment option in dermatology. According to plan, PhotoCure expects to file its first Market Authorisation Application in Europe during year 2000. In order to achieve this, PhotoCure has already prepared a draft version of the Market Authorisation Application.
AK is a pre-malignant lesion, also called sun damaged skin. BCC is the most frequent form of non melanoma skin cancer and High Risk BCC lesions are BCC lesions that is not suitable for traditional therapy due to size, location or previous treatment. BCC and AK are frequent sun induced lesions and the incidence is especially high among fair-skinned people living in sun rich areas. In the European Union it is estimated that the incidence of BCC is approximately 400,000 people per year and the corresponding figure for AK is approximately 3 million people per year.
An important milestone was achieved early October when patient treatment was finished in PhotoCures two final clinical registration studies (phase III) for AK. In these two studies Metvix® is compared to placebo respectively cryo surgery. A total of 242 patients are included and evaluation of response is being performed three months after treatment.
Early November patient treatment was also finished in PhotoCures final clinical registration study (phase II) for High Risk BCC. In this study BCC lesions that is not suitable for traditional therapy due to size, location or previous treatment are treated with Metvix®. For this specific indication, PhotoCure assumes that a Market Authorisation Application in Europe can be filed based on the phase II study. A total of 94 patients are included and evaluation of response is being performed 3 months and one year after treatment.
An important target for PhotoCure was achieved in October when patient inclusion started in two pivotal clinical studies (phase III) for BCC. In the first study Metvix® is compared to excision surgery in the treatment of nodular BCC (thick BCC lesions) and in the second Metvix® is compared to cryo surgery in the treatment of superficial BCC (thin BCC lesions). A total of 130 patients will be included in each of the two studies.
CE mark obtained for Curelight
The Curelight lamp is used in clinical trials performed by PhotoCure and the light source activates the photosensitiser that accumulates in the target tissue after application of Metvix®. Curelight is now approved as a medical device type IIa and a CE mark is obtained, which means that Curelight complies with the necessary European quality requirements.
Metvix® has obtained 12 months stability approval
PhotoCure has obtained 12 months stability approval for the Metvix® cream in clinical trials, and formal stability studies for the active substance in Metvix® as well as the Metvix® cream itself progress as planned.
Pre-clinical research
PhotoCure has increased its pre-clinical research efforts addressing internal cancers, gene therapy and cancer vaccines. The company has initiated several research programs including pre-clinical studies involving new substances and a new research collaboration agreement has recently been signed with the University of Leeds. This agreement covers research with PhotoCures ALA esters. Thus PhotoCure has now on-going research programs with research centres such as The Norwegian Radium Hospital, The Imperial College of Science, Technology and Medicine in London as well as the University of Leeds.
An extraordinary Shareholder Meeting was held in September
At the general meeting Norsk Hydro was granted warranties to subscribe shares in the company according to the proposal from the Board of Directors. For further information see the attached minutes of meeting as well as the press release as of 30th of July 1999 that is available on the Internet site presented below. Furthermore the bylaws of the company were changed according to the proposal from the Board of Directors. The previous formal share transfer approval provision in the bylaws is now removed.
Information about PhotoCure available on Internet
Financial information about PhotoCure can be obtained by visiting this Internet address: www.huginonline.com/Norway/PHOT/
Previously disclosed press releases, financial reports, including the Prospectus prepared in April 1999, as well as a PowerPoint presentation of the company are available at this Internet site.
PhotoCure will as soon as new financial reports and press releases are disclosed make these available on the Internet site. Furthermore, new reports and press releases will be sent by e-mail to those who return the Reply Card that is attached to this financial report.
Financial accounts as of 30.9 1999
PhotoCure has a limited sale of products under development, mainly to the pharmacy at the Norwegian Radium Hospital. Total sales amounted to NOK 717,400 for the nine months period ended 30.9 1999 compared to NOK 660,500 for the nine months period ended 30.9 1998. PhotoCure receives Government grants from Statens Nærings- og Distriktutviklingsfond (SND) and Norges Forskningsråd (NFR). Government grants for the first nine months of 1999 amounted to NOK 3,338,943. Comparable figures for 1998 was NOK 4,461,681. Existing grant program from SND is now fully utilised and government grants received will be less in 1999 compared to 1998.
Total operating expenses amounted to NOK 29,347,192 for the first nine months of 1999 compared to NOK 14,687,095 in the first nine months of 1998. All research and development costs are charged as expenses and the increase in operating expenses compared to 1998 is mainly related to an increase in the number of ongoing clinical trials. PhotoCure expects the operating expenses in the last three months in 1999 on a monthly basis to increase compared to the first nine months due to the increased number of ongoing clinical trials. However, accumulated development costs are at an acceptable level and are within the forecast of the company.
The company had an operating loss of NOK 25,290,849 for the first nine months of 1999 compared to an operating loss of NOK 9,564,914 for the first nine months of 1998. Net financial items totalled NOK 3,622,417 for the first nine months compared to NOK 939,626 in 1998. Pre-tax loss for the first nine months amounted to NOK 21,668,432 compared to a pre-tax loss of NOK 8,625,288 the first nine months last year. For the year 1998 the pre-tax loss totalled NOK 10,276,550.
PhotoCures capital resources are significantly strengthened as a result of the equity issue that was completed in early June this year. The major part of the companys liquid funds is invested in Money Market Funds.
The increase in short term liabilities is mainly due to provisions for accrued development costs. Total equity was NOK 112,231,993 as of 30.9.99 compared to NOK 54,203,352 as of 30.9.98.
For report with tables follow the enclosed link: