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Photocure ASA (OSL:PHO) Oslo, Norway, 9 September 2008 - Photocure's newly developed third-generation lamp, Aktilite CL512, for use in photodynamic therapy (PDT), has received a CE mark and is now certified by Nemko, the official Notified Body within EU/EEA for medical devices.
The lamp is designed to illuminate areas of skin that have been treated with Visonac(TM), Photocure's new photodynamic therapy for moderate and severe acne, thereby activating the photosensitive therapeutic ingredient (methyl aminolevulinate) within this product. Aktilite CL512 will be used in the phase III clinical trials with Visonac(TM) in this indication, currently being planned following the successful completion of the phase II program.
Aktilite CL512 has been specifically designed for illuminating larger skin surfaces. The lamp has two adjustable panels with a total of 512 light emitting diodes (LEDs) giving a red light of 633 nm over an area of approximately 32 cm x 18 cm. Aktilite CL512 is suitable for use on most parts of the body but is specifically designed to provide treatment of the face and torso. For facial treatment the two panels are symmetrically located on either side of the face while for treatment of areas on the torso a flat position, where the two panels are placed alongside each other is used.
Kjetil Hestdal, President & CEO of Photocure, comments:" We have recently completed a phase II clinical program with Visonac(TM) for treatment of moderate to severe acne. The phase II data demonstrated that the Visonac (TM) treatment is effective at reducing acne lesions and is well tolerated. The data are now being analyzed and will be discussed with the US and EU regulatory agencies prior to start of the phase III clinical program. The Aktilite CL 512 lamp will be an essential component of the Visonac(TM) photodynamic therapy procedure and I am pleased that it will be ready for use in the phase III program."
About Visonac(TM) Visonac PDT is a photodynamic therapy that combines the Visonac cream with controlled illumination by a red light source. Visonac cream contains the active substance methyl aminolevulinate. The cream is applied to the acne area to be treated and after a short incubation time, the skin is illuminated with red light. The PDT procedure kills bacteria and appears to have a beneficial effect on sebaceous glands and inflammatory cells.
About acne Acne is a common skin condition which affects up to 85% of adolescents. Each year, US dermatologists register nearly 3 million visits concerning acne. Of those who seek medical advice from a dermatologist, about 50% have moderate and 20% have severe acne.
Current therapies for these patients include oral antibiotics and isotretinoin, both products that may have significant adverse effects. There is thus a clear medical need for a safe and efficacious topical treatment for acne patients.
For further information, contact: President and CEO Kjetil Hestdal E-mail: kh@photocure.no Mobile: +47 913 19 535 Office: +47 22 06 22 10
CFO Christian Fekete E-mail: cf@photocure.no Mobile: +47 916 42 938 Office: +47 22 06 22 10 www.photocure.com
Photocure ASA is a Norwegian pharmaceutical company listed on the Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer.
Photocure has two proprietary pharmaceutical products on the market: Metvix®, for the treatment of sun-damaged skin and certain types of skin cancer, and Hexvix®, for the diagnosis of bladder cancer. In addition, the company has developed a proprietary light source, the Aktilite® lamp, which is used in combination with the Metvix cream. Through worldwide studies, Photocure is continuously testing its products for new indications, and the aim is to develop a pipeline of follow-on products and technologies.
Photocure®, Metvix®, Hexvix® and Aktilite® are registered trademarks of Photocure ASA.
