Oslo, Norway, 29 November 2010: Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company focused in dermatology and oncology, announces positive preliminary results from its consumer trial on Allumera™, demonstrating that the product can improve the appearance of skin.
The RevitAll study was designed to determine the ability of Allumera™ cream to improve the appearance of skin compared to illumination by light alone.
This prospective and controlled cosmetic study included 120 women of which 60 women received three applications of Allumera(TM) one month apart. The remaining 60 received light alone. The total study duration was five months. The four month data presented today represent the results obtained two months after the last session. Subjects who received Allumera™ for one hour followed by illumination showed a time dependent and significant reduction in the appearance of pores (p<0.01), significant improvement in skin appearing more supple (p<0.05), and a significant increase in skin appearing firmer (p<0.05) compared to base line as well as light alone. In addition, there was a significant improvement in the appearance of even skin tone (p<0.05) compared to baseline. However, this improvement in the appearance of even skin tone did not reach statistical significance compared to light alone.
The majority of women receiving Allumera™ reported substantial benefits across important personal cosmetic evaluations measurements. Moreover, the data demonstrated excellent safety and tolerability. Allumera™ followed by illumination was well tolerated with few side effects and minimal down-time. No study participants in either group experienced side effect which caused withdrawal from the study.
The company plans to bring Allumera™ to the US aesthetic dermatology market via its newly established US subsidiary within the first half of 2011 and is preparing to present this study and others at key aesthetic dermatology meetings over the course of 2011. Allumera(TM) will offer a potential new convenient way for consumers to receive cosmetic benefits without significant down-time or other side effects.
Kjetil Hestdal, President & CEO of Photocure ASA noted, "This trial provides strong evidence for applications of our technology in dermatology. We have developed Allumera(TM) to enter the US dermatology market as an effective and tolerable product to improve the appearance of skin."
"Dermatologists have long understood the cosmetic benefits of photodynamic therapy", notes Dr. Michael Gold Assistant Clinical Professor of Dermatology at Vanderbilt University; "and the Dermatology community is looking forward to having access to a commercial product like Allumera™ that's been specifically developed for this purpose".
Based on these encouraging results, and to support the launch and appropriate use of Allumera™ in the aesthetic dermatology market, Photocure sponsors key opinion leaders in the field initiating the GLOW Program. This is a group of about 15 studies investigating how to use Allumera™ to improve the appearance of the skin. Photocure supports these cosmetic trials to help guide practitioners as to best practices withAllumera™ .
For further information, please contact
President & CEO, Kjetil Hestdal
Phone: + 47 913 19 535
CFO, Christian Fekete
Phone: + 47 916 42 938
Mary Clark, Justine Lamond and Hollie Vile
Ph: +44 (0)20 7307 5337
Photocure initiated the development of Allumera, a cosmetic product for the dermatology market, in 2009. Allumera is built on the reported cosmetic improvements experienced with Photocure's divested cancer product Metvix/Aktilite. Today the cosmetic procedure market in US alone has an estimated value of USD 4 billion. Photocure's market research has shown the benefits observed with Allumera in the pilot trial offer advantages which will fit well within the current cosmetic procedures performed by dermatologists.
Photocure started a consumer trial (RevitAll™) for Allumera in April 2010. Final results of the trial are expected during the first quarter of 2011. Photocure is working towards introduction of Allumera in the US in the first half of 2011.
Photocure is a Norwegian speciality pharmaceutical company listed on the Oslo Stock Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications.
Photocure's commercial activities includes own marketing and sales in selected markets as well as out-licensing to leading pharmaceutical companies on a regional or global basis prior to Phase III.
Photocure has one proprietary pharmaceutical product on the market: Hexvix®, for the diagnosis of bladder cancer. Hexvix® is approved in Europe and in the US. In addition, the company has developed a proprietary light source, which is used in combination with the Visonac™ 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 based on the Photocure Technology™ platform. Photocure® and Hexvix® are registered trademarks of Photocure ASA.
For more information about Photocure, visit our website at www.photocure.com
This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)