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Oslo, 13 March 2008.
Photodynamic Therapy (PDT) attracted high interest at the international EuroPDT meeting as new studies confirming the efficacy and reliability of PDT is released. More than 175 publications are now published with Metvix PDT. At the same congress new evidence of the preventive effect of PDT for skin cancer was presented to 250 dermatologists.
The 8th Euro-PDT Congress was arranged by the European Society for Photodynamic Therapy in Dermatology on 6-9 March, and focused on current and future developments of PDT.
The congress offered specialists the opportunity to learn how PDT can improve the medical strategies in dermatology. The meeting promotes interactive discussions on PDT use in Europe, with many practitioners and researchers participating in the scientific program. Dr. Alex Camps-Fresneda, from Centro Medico Teknon, Barcelona, Spain, the leader of the congress, states
“With the rapid increase in clinical research on photodynamic therapy there is a need to create a communications platform between researchers working with fluorescence diagnosis and photodynamic therapy. Congresses like this facilitates to promote international cooperation that in the end will benefit patients worldwide.”
Upcoming events in the PDT field by Euro-PDT can be found at www.euro-pdt.com
Metvix is approved in the EU/EEA for treatment of actinic keratosis, Bowen's Disease (BD) and Basal Cell Carcinoma (BCC). Non melanoma skin cancer (NMSC) is a classification that covers most skin cancers, skin cancers that normally develop on sun-exposed areas of the body, like the face, ear, neck, lips, and the backs of the hands.
Actinic keratosis (AK) is the most common premalignant skin lesion, frequently found on the hands, arms, head and other sun exposed areas. AK can develop into squamous cell carcinoma (SCC), which is an aggressive type of cancer that grows invasively into deeper layers of the skin and can spread and form metastases. BCC is the most common malignant skin cancer. They are locally aggressive tumours that rarely metastasise (spread to other organs), but destroy surrounding tissue. Bowen's disease is a pre-stage of SCC where the tumour has not spread, but has the potential to progress into invasive squamous cell carcinoma. It usually looks like a slow growing red, scaly patch.
PDT is an effective, targeted treatment that destroys cancer cells without harming surrounding tissue. Red light is used to activate a light sensitive substance that accumulates selectively in cancer cells.
Photodynamic Therapy (PDT) attracted high interest at the international EuroPDT meeting as new studies confirming the efficacy and reliability of PDT is released. More than 175 publications are now published with Metvix PDT. At the same congress new evidence of the preventive effect of PDT for skin cancer was presented to 250 dermatologists.
The 8th Euro-PDT Congress was arranged by the European Society for Photodynamic Therapy in Dermatology on 6-9 March, and focused on current and future developments of PDT.
The congress offered specialists the opportunity to learn how PDT can improve the medical strategies in dermatology. The meeting promotes interactive discussions on PDT use in Europe, with many practitioners and researchers participating in the scientific program. Dr. Alex Camps-Fresneda, from Centro Medico Teknon, Barcelona, Spain, the leader of the congress, states
“With the rapid increase in clinical research on photodynamic therapy there is a need to create a communications platform between researchers working with fluorescence diagnosis and photodynamic therapy. Congresses like this facilitates to promote international cooperation that in the end will benefit patients worldwide.”
Upcoming events in the PDT field by Euro-PDT can be found at www.euro-pdt.com
Metvix is approved in the EU/EEA for treatment of actinic keratosis, Bowen's Disease (BD) and Basal Cell Carcinoma (BCC). Non melanoma skin cancer (NMSC) is a classification that covers most skin cancers, skin cancers that normally develop on sun-exposed areas of the body, like the face, ear, neck, lips, and the backs of the hands.
Actinic keratosis (AK) is the most common premalignant skin lesion, frequently found on the hands, arms, head and other sun exposed areas. AK can develop into squamous cell carcinoma (SCC), which is an aggressive type of cancer that grows invasively into deeper layers of the skin and can spread and form metastases. BCC is the most common malignant skin cancer. They are locally aggressive tumours that rarely metastasise (spread to other organs), but destroy surrounding tissue. Bowen's disease is a pre-stage of SCC where the tumour has not spread, but has the potential to progress into invasive squamous cell carcinoma. It usually looks like a slow growing red, scaly patch.
PDT is an effective, targeted treatment that destroys cancer cells without harming surrounding tissue. Red light is used to activate a light sensitive substance that accumulates selectively in cancer cells.
Oslo, Norway, February 28, 2008
Photocure ASA (Oslo Stock Exchange: PHO) today presents its results for the fourth quarter 2007 and for the full year 2007. A meeting will take place today in Oslo, Norway, beginning at 08.15 am (CET) and webcast through the Company's website www.photocure.no.
The main items in the report are:
• Hexvix sales increased 108% to NOK 21.0 million in 2007
The revenue from sales of Hexvix bladder cancer diagnostic increased to NOK 8.8 million in the fourth quarter 2007, an increase of 66% over the same period in 2006. Of these sales, NOK 2.0 million came from sales by Photocure in the Nordic region and NOK 6.8 million from sales by GE Healthcare, its commercial partner for Hexvix outside the Nordic region. Comparable figures for 2006 are NOK 5.3 million, NOK 0.4 million and NOK 4.9 million, respectively. In addition to this, Photocure received a NOK 72.5 million milestone payment from GE Healthcare in the fourth quarter 2006 for the rights to market and sell Hexvix in the US.
Over the full year period, revenue from Hexvix increased 108% to NOK 21.0 million in 2007 compared to 2006 split NOK 6.0 million from Photocure in the Nordic region and NOK 15.0 million from GE Healthcare outside the Nordic region. Comparable figures for 2006 are NOK 10.1 million, NOK 2.1 million and NOK 8.0 million, respectively. In addition to this, Photocure received a total of NOK 133.0 million in milestone payments from GE Healthcare in 2006 related to the Licensing agreement for Hexvix.
• Metvix sales increased 5% to NOK 54.2 million in 2007
Revenue from sales of Metvix/Aktilite for the photodynamic treatment of cancerous and precancerous skin lesions decreased 12.3% to NOK 14.8 million in the fourth quarter 2007 compared to the same period for 2006. Photocures sales of Metvix/Aktilite in the Nordic region increased to NOK 7.6 million from NOK 7.2 million in 2006 and the revenue from Galderma, our commercial partner for Metvix/Aktilite outside the Nordic region, decreased 26.2% to NOK 7.1 million in the fourth quarter 2007 compared with the same period in 2006.
Over the full year period, revenue from Metvix/Aktilite increased 5.2% to NOK 54.2 million in 2007 compared to 2006. Revenue from Metvix/Aktilite from Photocures own sales in the Nordic region increased by 15.6% to NOK 23.1 million and revenue from Galderma, decreased by 1.4% to NOK 31.2 million in 2007. The decrease in revenues from Galderma is a result of fewer Aktilite sales, lower cost of goods and lower average selling price. The volume of sales in units, however, increased by 21% from 2006 to 2007.
• Significant progress in clinical programs
Based on two phase III studies with Metvix/Aktilite in EU/US, which were completed in 2007, a supplemental NDA for Aktilite was submitted to FDA in June 2007. Photocure expects a response from FDA in Q2 2008.
Patient recruitment was completed for a US phase III study of Hexvix with results expected in Q4 2008.
Photocures US phase IIb clinical study with methyl aminolevulinate (MAL) photodynamic therapy (PDT) for treatment of moderate to severe acne progressed according to plan and was completed in February 2008. The results are expected in Q4 2008.
Patient recruitment was completed for a phase I/II study with Cevira(TM), our new PDT for the treatment of HPV infections and precancerous lesions of the cervix. Results are expected in Q3 2008.
Patient recruitment was completed for a phase I/II study of our new fluorescence-based photodynamic diagnostic (PDD) product, named Lumacan(TM), for detection of early colon cancers. Preliminary results showed 37% improvement in detection of colon cancer compared to current standard colonoscopy. Full results will be presented in May 2008.
• PCI Biotech
Preparations are underway for the first clinical trial of a light-directed therapy based on technology developed at PCI Biotech, our cancer-focused drug delivery subsidiary.
The Board has decided to de-merge PCI Biotech, which the Directors believe will give it the best possible opportunity to become a successful biotech company in its own right as well as releasing the value that this creates to shareholders.
• Financial results
Total revenue was NOK 27.5 million in the fourth quarter 2007, compared to NOK 98.5 million in the fourth quarter 2006. Profit after tax was NOK -16.3 million in the fourth quarter 2007 compared to
NOK 54.5 million in the fourth quarter 2006. The figures in the fourth quarter of 2006 reflect the positive impact of a milestone payment relating to Hexvix from GE Healthcare.
Total revenue for the full year 2007 was NOK 99.0 million, compared to NOK 210.3 million in 2006. Profit after tax was NOK -75.0 million in 2007, compared to NOK 78.4 million in 2006. As in the fourth quarter, the full year 2006 figures reflect the positive impact of milestone payments from GE Healthcare.
The increase in operating expenses of NOK 61.3 million in 2007 compared to 2006 reflects planned increase in activities in clinical programs as well as marketing and sales.
Cash flow from operations was NOK -95.7 million in 2007, compared to NOK 66.4 million in 2006. Liquid funds amounted to NOK 252.5 million as of 31.12.2007.
President and CEO of Photocure, Kjetil Hestdal MD, Ph.D., says in a comment to the results, "We are pleased to see that sales of Hexvix and Metvix continued to grow during 2007. These are products that we believe offer both significant clinical benefits to patients and considerable economic benefits to healthcare payers and we are confident that their uptake will continue to increase over the coming years.
"Furthermore, our pipeline of novel photodynamic products targeting acne, cervical cancer therapy (Cevira) and colon cancer detection (Lumacan) made considerable progress in 2007 and development of these proceeded according to our plans. We expect to see some interesting data emerging from the clinical trials underway with these product candidates during 2008."
Photocure ASA is a Norwegian pharmaceutical company founded in 1993 and listed on Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices based on proprietary photodynamic technologies, targeting key dermatology and oncology markets.
Photocure has two products with sales and marketing approvals: Metvix®, which is a product developed for the treatment of skin cancer (basal cell carcinoma) and pre-cancerous skin lesions (actinic keratosis), and Hexvix®, which is developed for the detection of bladder cancer. Both products are based on the same photodynamic technology, combining the drug known as a photosensitiser with a light source that activates the photosensitiser. Photocure aims to develop a pipeline of follow-on products and technologies.
For further information, contact:
Photocure ASA (Oslo Stock Exchange: PHO) today presents its results for the fourth quarter 2007 and for the full year 2007. A meeting will take place today in Oslo, Norway, beginning at 08.15 am (CET) and webcast through the Company's website www.photocure.no.
The main items in the report are:
• Hexvix sales increased 108% to NOK 21.0 million in 2007
The revenue from sales of Hexvix bladder cancer diagnostic increased to NOK 8.8 million in the fourth quarter 2007, an increase of 66% over the same period in 2006. Of these sales, NOK 2.0 million came from sales by Photocure in the Nordic region and NOK 6.8 million from sales by GE Healthcare, its commercial partner for Hexvix outside the Nordic region. Comparable figures for 2006 are NOK 5.3 million, NOK 0.4 million and NOK 4.9 million, respectively. In addition to this, Photocure received a NOK 72.5 million milestone payment from GE Healthcare in the fourth quarter 2006 for the rights to market and sell Hexvix in the US.
Over the full year period, revenue from Hexvix increased 108% to NOK 21.0 million in 2007 compared to 2006 split NOK 6.0 million from Photocure in the Nordic region and NOK 15.0 million from GE Healthcare outside the Nordic region. Comparable figures for 2006 are NOK 10.1 million, NOK 2.1 million and NOK 8.0 million, respectively. In addition to this, Photocure received a total of NOK 133.0 million in milestone payments from GE Healthcare in 2006 related to the Licensing agreement for Hexvix.
• Metvix sales increased 5% to NOK 54.2 million in 2007
Revenue from sales of Metvix/Aktilite for the photodynamic treatment of cancerous and precancerous skin lesions decreased 12.3% to NOK 14.8 million in the fourth quarter 2007 compared to the same period for 2006. Photocures sales of Metvix/Aktilite in the Nordic region increased to NOK 7.6 million from NOK 7.2 million in 2006 and the revenue from Galderma, our commercial partner for Metvix/Aktilite outside the Nordic region, decreased 26.2% to NOK 7.1 million in the fourth quarter 2007 compared with the same period in 2006.
Over the full year period, revenue from Metvix/Aktilite increased 5.2% to NOK 54.2 million in 2007 compared to 2006. Revenue from Metvix/Aktilite from Photocures own sales in the Nordic region increased by 15.6% to NOK 23.1 million and revenue from Galderma, decreased by 1.4% to NOK 31.2 million in 2007. The decrease in revenues from Galderma is a result of fewer Aktilite sales, lower cost of goods and lower average selling price. The volume of sales in units, however, increased by 21% from 2006 to 2007.
• Significant progress in clinical programs
Based on two phase III studies with Metvix/Aktilite in EU/US, which were completed in 2007, a supplemental NDA for Aktilite was submitted to FDA in June 2007. Photocure expects a response from FDA in Q2 2008.
Patient recruitment was completed for a US phase III study of Hexvix with results expected in Q4 2008.
Photocures US phase IIb clinical study with methyl aminolevulinate (MAL) photodynamic therapy (PDT) for treatment of moderate to severe acne progressed according to plan and was completed in February 2008. The results are expected in Q4 2008.
Patient recruitment was completed for a phase I/II study with Cevira(TM), our new PDT for the treatment of HPV infections and precancerous lesions of the cervix. Results are expected in Q3 2008.
Patient recruitment was completed for a phase I/II study of our new fluorescence-based photodynamic diagnostic (PDD) product, named Lumacan(TM), for detection of early colon cancers. Preliminary results showed 37% improvement in detection of colon cancer compared to current standard colonoscopy. Full results will be presented in May 2008.
• PCI Biotech
Preparations are underway for the first clinical trial of a light-directed therapy based on technology developed at PCI Biotech, our cancer-focused drug delivery subsidiary.
The Board has decided to de-merge PCI Biotech, which the Directors believe will give it the best possible opportunity to become a successful biotech company in its own right as well as releasing the value that this creates to shareholders.
• Financial results
Total revenue was NOK 27.5 million in the fourth quarter 2007, compared to NOK 98.5 million in the fourth quarter 2006. Profit after tax was NOK -16.3 million in the fourth quarter 2007 compared to
NOK 54.5 million in the fourth quarter 2006. The figures in the fourth quarter of 2006 reflect the positive impact of a milestone payment relating to Hexvix from GE Healthcare.
Total revenue for the full year 2007 was NOK 99.0 million, compared to NOK 210.3 million in 2006. Profit after tax was NOK -75.0 million in 2007, compared to NOK 78.4 million in 2006. As in the fourth quarter, the full year 2006 figures reflect the positive impact of milestone payments from GE Healthcare.
The increase in operating expenses of NOK 61.3 million in 2007 compared to 2006 reflects planned increase in activities in clinical programs as well as marketing and sales.
Cash flow from operations was NOK -95.7 million in 2007, compared to NOK 66.4 million in 2006. Liquid funds amounted to NOK 252.5 million as of 31.12.2007.
President and CEO of Photocure, Kjetil Hestdal MD, Ph.D., says in a comment to the results, "We are pleased to see that sales of Hexvix and Metvix continued to grow during 2007. These are products that we believe offer both significant clinical benefits to patients and considerable economic benefits to healthcare payers and we are confident that their uptake will continue to increase over the coming years.
"Furthermore, our pipeline of novel photodynamic products targeting acne, cervical cancer therapy (Cevira) and colon cancer detection (Lumacan) made considerable progress in 2007 and development of these proceeded according to our plans. We expect to see some interesting data emerging from the clinical trials underway with these product candidates during 2008."
Photocure ASA is a Norwegian pharmaceutical company founded in 1993 and listed on Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices based on proprietary photodynamic technologies, targeting key dermatology and oncology markets.
Photocure has two products with sales and marketing approvals: Metvix®, which is a product developed for the treatment of skin cancer (basal cell carcinoma) and pre-cancerous skin lesions (actinic keratosis), and Hexvix®, which is developed for the detection of bladder cancer. Both products are based on the same photodynamic technology, combining the drug known as a photosensitiser with a light source that activates the photosensitiser. Photocure aims to develop a pipeline of follow-on products and technologies.
For further information, contact:
Oslo, Norway, February 28, 2008
The Board of Photocure ASA ("Photocure") has on February 27, 2008 decided to propose a demerger for the general assembly of Photocure. Photocures share of 91.43 % in PCI Biotech AS ("PCI Biotech") is then transferred to a holding company; PCI Biotech Holding ASA ("PCI Holding"). The Board of Directors of both companies have signed a plan for the demerger. The plan includes the detailed steps in the demerger, and assumes that PCI Holding is listed on Oslo Axess.
The Board of Directors has decided to perform a share issue in PCI Holding prior to the listing. The share issue will partly be for subscription by Photocures existing shareholders, and partly for new investors. Photocure will guarantee for a subscription of up to NOK 30 million in the share issue.
Photocures shareholders will be allocated one share in PCI Holding for each share owned in Photocure at the date of the demerger.
Based on the valuation prepared for the Board of Directors of Photocure and PCI Holding, the Board of Directors have concluded on a split that allocates 94.69 % of the net value in the demerger to the assets, rights and liabilities of Photocure and that 5.31 % of the net value is allocated to the assets, rights and liabilities of PCI Holding.
There are certain conditions for the demerger, including that an agreement is signed so that the minority shareholders in PCI Biotech receive new shares in PCI Holding. This way PCI Holding will be the 100 % owner of PCI Biotech.
The plan is to have the demerger on the agenda for the general assembly in Photocure on April 9, 2008. The plan for the demerger will be sent to all shareholders and registered in the Company register one month prior to the general assembly at the latest. The plan is to execute the demerger in June 2008.
The rationale for the demerger is the following: Firstly, PCI Biotech is a drug-delivery company and very different from Photocures focus on diagnosis and therapy. The demerger will allow Photocure to focus on the remaining activities, both commercially and within research and development. Secondly, Photocures Board of Directors is of the opinion that PCI Biotech will get a better platform for future development of the PCI-technology as a separate company. The demerger will be an opportunity to crystallize more of the value and give each shareholder an opportunity to increase/decrease their position in both companies.
PCI Biotech is a subsidiary of Photocure, a listed pharmaceutical company. PCI Biotech has a unique method for delivery of therapeutic molecules directly into the cells. The technology called photochemical internalisation (PCI) can be used to improve existing and novel cytotoxic drugs, in addition to development of new and innovative treatment modalities such as gene therapy.
PCI Biotech has a solid preclinical documentation and strong intellectual property-platform. In the beginning of 2007, two patent applications related to the combination of PCI/siRNA and other olegonucleotides were transferred from the Radium Hospital's Research Foundation to PCI Biotech.
PCI Biotech had revenues of NOK 5.9 million in 2007 compared to NOK 4.1 million in 2006. The increase in revenues was due to increase in research grants.
PCI Biotech had operating expenses of NOK 16.0 million in 2007 compared to NOK 7.9 million in 2006. The increase in operating expenses was due to increased research and development activities.
PCI Biotech's operating loss increased from NOK 3.8 million in 2006 to NOK 10.2 million in 2007. PCI Biotech's net loss was NOK 10.1 million in 2007.
PCI Biotech had NOK 3.7 million in cash, NOK 4.0 in receivables and total assets of NOK 7.9 million at December 31, 2007.
A significant share of the value in PCI Biotech is the patents and patent applications related to the PCI-technology.
Per Walday is hired as new CEO of PCI Holding starting in the beginning of second quarter 2008. Anders Høgset, CEO today, will take a position as Chief Scientific Officer from the second quarter 2008. Christian Fekete and Kjell-Erik Nordby will be hired part-time as CFO and Vice President Business Development according to an agreement between PCI Holding and Photocure.
PCI Biotech has 4 employees. In addition, approximately 20 scientists and technical staff at the Norwegian Radium Hospital work with development of the PCI-technology.
The Board of Directors of PCI Biotech Holding ASA consists of Kjetil Hestdal, Christian Fekete and Inger Ferner Heglund. A new Board of Directors will be elected and be effective from the listing on Oslo Axess.
There are no agreements made, or planned, in the demerger process favouring management or the Board members in Photocure or PCI Holding.
The Board of Photocure ASA ("Photocure") has on February 27, 2008 decided to propose a demerger for the general assembly of Photocure. Photocures share of 91.43 % in PCI Biotech AS ("PCI Biotech") is then transferred to a holding company; PCI Biotech Holding ASA ("PCI Holding"). The Board of Directors of both companies have signed a plan for the demerger. The plan includes the detailed steps in the demerger, and assumes that PCI Holding is listed on Oslo Axess.
The Board of Directors has decided to perform a share issue in PCI Holding prior to the listing. The share issue will partly be for subscription by Photocures existing shareholders, and partly for new investors. Photocure will guarantee for a subscription of up to NOK 30 million in the share issue.
Photocures shareholders will be allocated one share in PCI Holding for each share owned in Photocure at the date of the demerger.
Based on the valuation prepared for the Board of Directors of Photocure and PCI Holding, the Board of Directors have concluded on a split that allocates 94.69 % of the net value in the demerger to the assets, rights and liabilities of Photocure and that 5.31 % of the net value is allocated to the assets, rights and liabilities of PCI Holding.
There are certain conditions for the demerger, including that an agreement is signed so that the minority shareholders in PCI Biotech receive new shares in PCI Holding. This way PCI Holding will be the 100 % owner of PCI Biotech.
The plan is to have the demerger on the agenda for the general assembly in Photocure on April 9, 2008. The plan for the demerger will be sent to all shareholders and registered in the Company register one month prior to the general assembly at the latest. The plan is to execute the demerger in June 2008.
The rationale for the demerger is the following: Firstly, PCI Biotech is a drug-delivery company and very different from Photocures focus on diagnosis and therapy. The demerger will allow Photocure to focus on the remaining activities, both commercially and within research and development. Secondly, Photocures Board of Directors is of the opinion that PCI Biotech will get a better platform for future development of the PCI-technology as a separate company. The demerger will be an opportunity to crystallize more of the value and give each shareholder an opportunity to increase/decrease their position in both companies.
PCI Biotech is a subsidiary of Photocure, a listed pharmaceutical company. PCI Biotech has a unique method for delivery of therapeutic molecules directly into the cells. The technology called photochemical internalisation (PCI) can be used to improve existing and novel cytotoxic drugs, in addition to development of new and innovative treatment modalities such as gene therapy.
PCI Biotech has a solid preclinical documentation and strong intellectual property-platform. In the beginning of 2007, two patent applications related to the combination of PCI/siRNA and other olegonucleotides were transferred from the Radium Hospital's Research Foundation to PCI Biotech.
PCI Biotech had revenues of NOK 5.9 million in 2007 compared to NOK 4.1 million in 2006. The increase in revenues was due to increase in research grants.
PCI Biotech had operating expenses of NOK 16.0 million in 2007 compared to NOK 7.9 million in 2006. The increase in operating expenses was due to increased research and development activities.
PCI Biotech's operating loss increased from NOK 3.8 million in 2006 to NOK 10.2 million in 2007. PCI Biotech's net loss was NOK 10.1 million in 2007.
PCI Biotech had NOK 3.7 million in cash, NOK 4.0 in receivables and total assets of NOK 7.9 million at December 31, 2007.
A significant share of the value in PCI Biotech is the patents and patent applications related to the PCI-technology.
Per Walday is hired as new CEO of PCI Holding starting in the beginning of second quarter 2008. Anders Høgset, CEO today, will take a position as Chief Scientific Officer from the second quarter 2008. Christian Fekete and Kjell-Erik Nordby will be hired part-time as CFO and Vice President Business Development according to an agreement between PCI Holding and Photocure.
PCI Biotech has 4 employees. In addition, approximately 20 scientists and technical staff at the Norwegian Radium Hospital work with development of the PCI-technology.
The Board of Directors of PCI Biotech Holding ASA consists of Kjetil Hestdal, Christian Fekete and Inger Ferner Heglund. A new Board of Directors will be elected and be effective from the listing on Oslo Axess.
There are no agreements made, or planned, in the demerger process favouring management or the Board members in Photocure or PCI Holding.
Photocure ASA - Financial Calendar 2008
[Press Release]
Oslo, Norway, 19 February 2008.
Photocure ASA presents its financial calendar for 2008:
28 February 2008 - Presentation of the annual report 2007 (webcast)
23 April 2008 - Presentation of the first quarter report
15 August 2008 - Presentation of the second quarter report (webcast)
24 October 2008 - Presentation of the third quarter report
Photocure ASA is a Norwegian pharmaceutical listed on Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices based on proprietary photodynamic technologies, targeting key dermatology and oncology markets.
Photocure has two products with sales and marketing approvals: Metvix®, which is a product developed for the treatment of skin cancer (basal cell carcinoma) and pre-cancerous skin lesions (actinic keratosis), and Hexvix®, which is developed for the diagnosis of bladder cancer. Both products are based on the same photodynamic technology, combining the drug known as a photosensitiser with a light source that activates the photosensitiser. Photocure aims to develop a pipeline of follow-on products and technologies.
[Press Release]
Oslo, Norway, 19 February 2008.
Photocure ASA presents its financial calendar for 2008:
28 February 2008 - Presentation of the annual report 2007 (webcast)
23 April 2008 - Presentation of the first quarter report
15 August 2008 - Presentation of the second quarter report (webcast)
24 October 2008 - Presentation of the third quarter report
Photocure ASA is a Norwegian pharmaceutical listed on Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices based on proprietary photodynamic technologies, targeting key dermatology and oncology markets.
Photocure has two products with sales and marketing approvals: Metvix®, which is a product developed for the treatment of skin cancer (basal cell carcinoma) and pre-cancerous skin lesions (actinic keratosis), and Hexvix®, which is developed for the diagnosis of bladder cancer. Both products are based on the same photodynamic technology, combining the drug known as a photosensitiser with a light source that activates the photosensitiser. Photocure aims to develop a pipeline of follow-on products and technologies.
Photocure's new photodynamic diagnostic product shows early promise in detecting premalignant/malignant lesions in patients with suspected colorectal cancer
Interim Phase I/II clinical trial results published in the journal Endoscopy
Oslo, Norway, 12 February 2008 - Photocure is pleased to announce very encouraging interim results of its Phase I/II clinical study using its new photodynamic diagnostic product in development for the detection of colorectal polyps and tumours.
Photocure is developing its new fluorescence-based photodynamic diagnostic (PDD) product, named Lumacan(TM), to improve standard colonoscopy in patients with suspected colorectal cancer. This new product is based on its Hexvix® product, which is already approved in Europe for the improved diagnosis of bladder cancer lesions.
Patients with suspected colorectal cancer are routinely examined by visual inspection of the colon (colonoscopy). The entire colon is examined to find tumours and polyps, however, this approach is effective in identifying fewer than 80% of lesions, and those missed may progress to colorectal cancer.
Photocure has performed a dose-finding Phase I/II study at two hospitals in Germany using its PDD product in 32 patients with suspected colorectal cancer. Patients received local instillation of the photosensitive compound hexaminolevulinate (HAL) in the colon before proceeding with standard colonoscopy using both white and blue light. HAL is rapidly accumulated in metabolically active cancerous and precancerous cells and fluoresces red when illuminated with blue light.
The results from the first 12 patients have now been published in the February 2008 issue of Endoscopy* by Dr. Brigitte Mayinger, Hospital Munich-Pasing, the principle investigator of the study. Using histological findings as the gold standard, 52 of 53 (98%) of premalignant/malignant lesions showed red fluorescence under the PDD examination and 38 of 53 (72%) lesions were detected with white-light endoscopy. Photocures PDD approach therefore located 28% more polyps than identified with standard white-light endoscopic imaging.
No systemic or local side effects related to the use of HAL are reported. Patient recruitment for this trial was completed at the end of November 2007 and the full data from the study is currently being analysed.
Dr. Mayinger says, "Administration of HAL enema induces selective lesion fluorescence and increases the lesion detection rate in patients with colorectal adenoma and early carcinoma."
Kjetil Hestdal MD. Ph.D., President and CEO of Photocure, comments, "These published results strongly suggest that our new photodynamic diagnostic product will improve diagnosis of colorectal cancer to a similar extent to what we have shown can be achieved in patients with bladder cancer. We look forward to the full analysis of the trial, which we hope will confirm this highly encouraging result."
Colorectal cancer is one of the most common cancers, but only about 50% of patients survive for more than five years after diagnosis, owing to its highly invasive and metastatic nature. Colorectal cancer develops over 10-15 years and early diagnosis and treatment has the potential to reduce mortality from this disease by more than 90%. Colorectal polyps are quite common in the elderly population and health authorities in EU and US recommend that all women and men above 50 years should be screened. There are more than 10 million colonoscopies performed in EU and US annually.
*Mayinger, B., Neumann, F., Kastner, C., Degitz, K., Hahn, E. G. and Schwab, D.
Early detection of premalignant conditions in the colon by fluorescence endoscopy using local sensitization with hexaminolevulinate. Endoscopy (2008) Vol. 40, Issue 02
Photocure ASA is a Norwegian pharmaceutical listed on Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices based on proprietary photodynamic technologies, targeting key dermatology and oncology markets.
Photocure has two products with sales and marketing approvals: Metvix®, which is a product developed for the treatment of skin cancer (basal cell carcinoma) and pre-cancerous skin lesions (actinic keratosis), and Hexvix®, which is developed for the diagnosis of bladder cancer. Both products are based on the same photodynamic technology, combining the drug known as a photosensitiser with a light source that activates the photosensitiser. Photocure aims to develop a pipeline of follow-on products and technologies.
Interim Phase I/II clinical trial results published in the journal Endoscopy
Oslo, Norway, 12 February 2008 - Photocure is pleased to announce very encouraging interim results of its Phase I/II clinical study using its new photodynamic diagnostic product in development for the detection of colorectal polyps and tumours.
Photocure is developing its new fluorescence-based photodynamic diagnostic (PDD) product, named Lumacan(TM), to improve standard colonoscopy in patients with suspected colorectal cancer. This new product is based on its Hexvix® product, which is already approved in Europe for the improved diagnosis of bladder cancer lesions.
Patients with suspected colorectal cancer are routinely examined by visual inspection of the colon (colonoscopy). The entire colon is examined to find tumours and polyps, however, this approach is effective in identifying fewer than 80% of lesions, and those missed may progress to colorectal cancer.
Photocure has performed a dose-finding Phase I/II study at two hospitals in Germany using its PDD product in 32 patients with suspected colorectal cancer. Patients received local instillation of the photosensitive compound hexaminolevulinate (HAL) in the colon before proceeding with standard colonoscopy using both white and blue light. HAL is rapidly accumulated in metabolically active cancerous and precancerous cells and fluoresces red when illuminated with blue light.
The results from the first 12 patients have now been published in the February 2008 issue of Endoscopy* by Dr. Brigitte Mayinger, Hospital Munich-Pasing, the principle investigator of the study. Using histological findings as the gold standard, 52 of 53 (98%) of premalignant/malignant lesions showed red fluorescence under the PDD examination and 38 of 53 (72%) lesions were detected with white-light endoscopy. Photocures PDD approach therefore located 28% more polyps than identified with standard white-light endoscopic imaging.
No systemic or local side effects related to the use of HAL are reported. Patient recruitment for this trial was completed at the end of November 2007 and the full data from the study is currently being analysed.
Dr. Mayinger says, "Administration of HAL enema induces selective lesion fluorescence and increases the lesion detection rate in patients with colorectal adenoma and early carcinoma."
Kjetil Hestdal MD. Ph.D., President and CEO of Photocure, comments, "These published results strongly suggest that our new photodynamic diagnostic product will improve diagnosis of colorectal cancer to a similar extent to what we have shown can be achieved in patients with bladder cancer. We look forward to the full analysis of the trial, which we hope will confirm this highly encouraging result."
Colorectal cancer is one of the most common cancers, but only about 50% of patients survive for more than five years after diagnosis, owing to its highly invasive and metastatic nature. Colorectal cancer develops over 10-15 years and early diagnosis and treatment has the potential to reduce mortality from this disease by more than 90%. Colorectal polyps are quite common in the elderly population and health authorities in EU and US recommend that all women and men above 50 years should be screened. There are more than 10 million colonoscopies performed in EU and US annually.
*Mayinger, B., Neumann, F., Kastner, C., Degitz, K., Hahn, E. G. and Schwab, D.
Early detection of premalignant conditions in the colon by fluorescence endoscopy using local sensitization with hexaminolevulinate. Endoscopy (2008) Vol. 40, Issue 02
Photocure ASA is a Norwegian pharmaceutical listed on Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices based on proprietary photodynamic technologies, targeting key dermatology and oncology markets.
Photocure has two products with sales and marketing approvals: Metvix®, which is a product developed for the treatment of skin cancer (basal cell carcinoma) and pre-cancerous skin lesions (actinic keratosis), and Hexvix®, which is developed for the diagnosis of bladder cancer. Both products are based on the same photodynamic technology, combining the drug known as a photosensitiser with a light source that activates the photosensitiser. Photocure aims to develop a pipeline of follow-on products and technologies.
Trading Spotlight
PCI Biotech strengthens the management team
[Press Release]
Oslo, Norway, 1 February 2008. PCI Biotech, Photocures cancer-focused drug delivery subsidiary, strengthens the management team and hires Per Walday as CEO.
Mr Per Walday has been appointed as new CEO of PCI Biotech starting in the second quarter of 2008. Mr Anders Høgset, current CEO will take the position as Chief Scientific Officer upon Mr Walday taking up his new position.
Mr Walday brings to PCI Biotech more than 20 years of senior management experience in the pharmaceutical sector. Mr Walday currently holds the position as Global Head of Project Management at GE Healthcare. In this position he has been responsible for project management of all pharmaceutical development. Mr Walday brings deep insight and long experience in pharmaceutical development, ranging from preclinical research to registration and commercialization of new products. He has an extensive international network and a thorough understanding of critical success factors in drug development. Mr Walday holds a PhD from the Institute of Biology at the University of Oslo.
Photocure President and CEO, Kjetil Hestdal, said: "Today's announcement is an important step for PCI Biotech. By strengthening PCI Biotech's management team we will secure the necessary expertise to develop and commercialise its patented technology. I am confident that PCI Biotech's delivery technology has an important role to play in enhancing the effectiveness both of current and of emerging treatments for cancer. I will also take the opportunity to thank Mr Anders Høgset for taking on the additional responsibility of CEO in a very research intensive period. I wish Mr Høgset all the best in his new position as Chief Scientific Officer. "
[Press Release]
Oslo, Norway, 1 February 2008. PCI Biotech, Photocures cancer-focused drug delivery subsidiary, strengthens the management team and hires Per Walday as CEO.
Mr Per Walday has been appointed as new CEO of PCI Biotech starting in the second quarter of 2008. Mr Anders Høgset, current CEO will take the position as Chief Scientific Officer upon Mr Walday taking up his new position.
Mr Walday brings to PCI Biotech more than 20 years of senior management experience in the pharmaceutical sector. Mr Walday currently holds the position as Global Head of Project Management at GE Healthcare. In this position he has been responsible for project management of all pharmaceutical development. Mr Walday brings deep insight and long experience in pharmaceutical development, ranging from preclinical research to registration and commercialization of new products. He has an extensive international network and a thorough understanding of critical success factors in drug development. Mr Walday holds a PhD from the Institute of Biology at the University of Oslo.
Photocure President and CEO, Kjetil Hestdal, said: "Today's announcement is an important step for PCI Biotech. By strengthening PCI Biotech's management team we will secure the necessary expertise to develop and commercialise its patented technology. I am confident that PCI Biotech's delivery technology has an important role to play in enhancing the effectiveness both of current and of emerging treatments for cancer. I will also take the opportunity to thank Mr Anders Høgset for taking on the additional responsibility of CEO in a very research intensive period. I wish Mr Høgset all the best in his new position as Chief Scientific Officer. "
...
Photocure announces plans to de-merge PCI Biotech
[Press Release]
De-merger will lead to the subsequent listing of PCI Biotech, Photocures cancer-focused drug delivery subsidiary, on the Oslo Stock Exchange.
Oslo, Norway, 16 November 2007
Photocure ASA (OSE: PHO), a company that develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of different types of cancer, announces that its Board of Directors has decided to a plan to de-merge PCI Biotech, its cancer-focused drug delivery subsidiary. Following the completion of the de-merger process, PCI Biotech intends to seek a public listing on the Oslo Stock Exchange.
PCI Biotech has developed a unique method for the light-directed drug delivery of therapeutic molecules directly into tumour cells. This internal delivery of drugs has the potential to enhance the efficacy of current approaches to the treatment of cancer. The technology, called photochemical internalisation (PCI), can be used both for existing anti-cancer drugs and for emerging treatments, such as gene therapy using siRNA, and as such is of increasing interest in the pharmaceutical and biotech industry.
The Board of Photocure has made this decision for two key reasons. First, PCI Biotech's focus on drug delivery is clearly distinct from Photocures existing and future business opportunities. The de-merger, therefore, will enable Photocure to focus entirely on its commercial ambitions and on the development of its exciting R&D pipeline. Second, Photocure believes that de-merging PCI Biotech will give PCI Biotech the best possible opportunity to develop its unique drug delivery technology and to release the value that this creates to shareholders.
PCI Biotech has been a subsidiary of Photocure since 2000, and the company has built a solid technology platform, generated significant preclinical documentation and established a strong intellectual property position. PCI Biotech plans to start the first clinical Proof-of-Concept study in 2008 to evaluate the ability of PCI Biotech's technology to deliver an established anti-cancer agent into tumour cells.
PCI Biotech's business strategy is to create value by improving the therapeutic profile of drugs, and capture value through licensing deals with pharmaceutical and biotechnology companies. Therefore, the company will be well positioned for further development through a listing on the Oslo Stock Exchange (Oslo Axess).
Photocure currently owns 91.4% of the shares in PCI Biotech AS. The remaining shares are owned by the Radium Hospital's Research Foundation 6.9%, and the employees of PCI Biotech AS 1.7%.
As a result of the de-merger, Photocure shareholders will receive one share in PCI Biotech for every share they own in Photocure. The plan is to strengthen the financial base of PCI Biotech by raising additional capital through a share issue in connection with the listing on the Oslo Stock Exchange (Oslo Axess).
The Board of Photocure will prepare a plan for the de-merger that will be sent to each shareholder during the first quarter 2008. The de merger plan will be on the agenda for a general assembly one month after distribution to the shareholders. After the general assembly there will be a two-month creditor notice period before the de-merger can be executed.
Photocure ASA has to shift the share premium reserve to other equity before 31 December 2007 in order to be able to execute the de-merger as planned. The Board of Photocure has therefore decided that this will be presented for an extraordinary general assembly on 3 December 2007. The invitation to the extraordinary general assembly will be distributed to shareholders today.
Photocure President and CEO, Kjetil Hestdal, said: "Today's announcement is an important step for both Photocure and PCI Biotech. By executing this planned de-merger we will allow both companies to focus on their respective strengths in the treatment and diagnosis of cancer and in drug delivery. At Photocure we believe we have an exciting future based on our current product portfolio and the new projects that we have in clinical development. I am also confident that PCI Biotech's delivery technology has an important role to play in enhancing the effectiveness both of current and of emerging treatments for cancer. By adopting this approach, the Board of Photocure believes that better returns for shareholders can be generated."
[Press Release]
De-merger will lead to the subsequent listing of PCI Biotech, Photocures cancer-focused drug delivery subsidiary, on the Oslo Stock Exchange.
Oslo, Norway, 16 November 2007
Photocure ASA (OSE: PHO), a company that develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of different types of cancer, announces that its Board of Directors has decided to a plan to de-merge PCI Biotech, its cancer-focused drug delivery subsidiary. Following the completion of the de-merger process, PCI Biotech intends to seek a public listing on the Oslo Stock Exchange.
PCI Biotech has developed a unique method for the light-directed drug delivery of therapeutic molecules directly into tumour cells. This internal delivery of drugs has the potential to enhance the efficacy of current approaches to the treatment of cancer. The technology, called photochemical internalisation (PCI), can be used both for existing anti-cancer drugs and for emerging treatments, such as gene therapy using siRNA, and as such is of increasing interest in the pharmaceutical and biotech industry.
The Board of Photocure has made this decision for two key reasons. First, PCI Biotech's focus on drug delivery is clearly distinct from Photocures existing and future business opportunities. The de-merger, therefore, will enable Photocure to focus entirely on its commercial ambitions and on the development of its exciting R&D pipeline. Second, Photocure believes that de-merging PCI Biotech will give PCI Biotech the best possible opportunity to develop its unique drug delivery technology and to release the value that this creates to shareholders.
PCI Biotech has been a subsidiary of Photocure since 2000, and the company has built a solid technology platform, generated significant preclinical documentation and established a strong intellectual property position. PCI Biotech plans to start the first clinical Proof-of-Concept study in 2008 to evaluate the ability of PCI Biotech's technology to deliver an established anti-cancer agent into tumour cells.
PCI Biotech's business strategy is to create value by improving the therapeutic profile of drugs, and capture value through licensing deals with pharmaceutical and biotechnology companies. Therefore, the company will be well positioned for further development through a listing on the Oslo Stock Exchange (Oslo Axess).
Photocure currently owns 91.4% of the shares in PCI Biotech AS. The remaining shares are owned by the Radium Hospital's Research Foundation 6.9%, and the employees of PCI Biotech AS 1.7%.
As a result of the de-merger, Photocure shareholders will receive one share in PCI Biotech for every share they own in Photocure. The plan is to strengthen the financial base of PCI Biotech by raising additional capital through a share issue in connection with the listing on the Oslo Stock Exchange (Oslo Axess).
The Board of Photocure will prepare a plan for the de-merger that will be sent to each shareholder during the first quarter 2008. The de merger plan will be on the agenda for a general assembly one month after distribution to the shareholders. After the general assembly there will be a two-month creditor notice period before the de-merger can be executed.
Photocure ASA has to shift the share premium reserve to other equity before 31 December 2007 in order to be able to execute the de-merger as planned. The Board of Photocure has therefore decided that this will be presented for an extraordinary general assembly on 3 December 2007. The invitation to the extraordinary general assembly will be distributed to shareholders today.
Photocure President and CEO, Kjetil Hestdal, said: "Today's announcement is an important step for both Photocure and PCI Biotech. By executing this planned de-merger we will allow both companies to focus on their respective strengths in the treatment and diagnosis of cancer and in drug delivery. At Photocure we believe we have an exciting future based on our current product portfolio and the new projects that we have in clinical development. I am also confident that PCI Biotech's delivery technology has an important role to play in enhancing the effectiveness both of current and of emerging treatments for cancer. By adopting this approach, the Board of Photocure believes that better returns for shareholders can be generated."
Oslo, Norway, 5 November 2007.
Photocures strategy is to secure a broad and long lasting protection of its technology platform in key markets worldwide.
Photocure has received a notification from the United States Patent and Trademark Office stating that a patent application for Hexvix in the US has been granted. The new patent is valid until 2019 and extends the current patent protection for Hexvix in the US by 3 years.
President and CEO, Kjetil Hestdal says in a comment:
"We are very pleased to see this result of our continuous commitment to strengthen our intellectual property of existing and new products. This broadening and extension of current patent protection of Hexvix in US is a major contribution to secure the success of Hexvix."
Photocures strategy is to secure a broad and long lasting protection of its technology platform in key markets worldwide.
Photocure has received a notification from the United States Patent and Trademark Office stating that a patent application for Hexvix in the US has been granted. The new patent is valid until 2019 and extends the current patent protection for Hexvix in the US by 3 years.
President and CEO, Kjetil Hestdal says in a comment:
"We are very pleased to see this result of our continuous commitment to strengthen our intellectual property of existing and new products. This broadening and extension of current patent protection of Hexvix in US is a major contribution to secure the success of Hexvix."
Results Third Quarter 2007
[Press Release]
Oslo, Norway, 26 October 2007
Photocure ASA (Oslo Stock Exchange: PHO) presents today its results for the third quarter of 2007. The main items of the report are:
- Sales revenues in the quarter amounted to NOK 15.6 million (14.6), an increase of 7 %.
- Sales revenues YTD amounted to NOK 51.7 million (39.5), an increase of 31 %.
- All R&D projects are on schedule. The R&D expenses were NOK 28.7 million (18.8).
- Net loss amounted to NOK -23.6 million (-11.8).
- Liquid assets amounted to NOK 271.7 million at the end of the period.
President and CEO of Photocure, Dr. Kjetil Hestdal, says in a comment to the results: "All clinical development projects are progressing to plan. However, we are not satisfied with our sales of Metvix outside the Nordic region in third quarter and will take action to improve this."
3rd Quarter Report
[Press Release]
Oslo, Norway, 26 October 2007
Photocure ASA (Oslo Stock Exchange: PHO) presents today its results for the third quarter of 2007. The main items of the report are:
- Sales revenues in the quarter amounted to NOK 15.6 million (14.6), an increase of 7 %.
- Sales revenues YTD amounted to NOK 51.7 million (39.5), an increase of 31 %.
- All R&D projects are on schedule. The R&D expenses were NOK 28.7 million (18.8).
- Net loss amounted to NOK -23.6 million (-11.8).
- Liquid assets amounted to NOK 271.7 million at the end of the period.
President and CEO of Photocure, Dr. Kjetil Hestdal, says in a comment to the results: "All clinical development projects are progressing to plan. However, we are not satisfied with our sales of Metvix outside the Nordic region in third quarter and will take action to improve this."
3rd Quarter Report
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