Earnings Release • Dec 14, 2015
Earnings Release
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Photocure: Visonac® data published in the British Journal of Dermatology
Phase 2b results demonstrate a significant reduction in inflammatory lesions and
a significant improvement in overall acne severity
Oslo, Norway, December 14, 2015: Photocure (OSE: PHO), a specialty
pharmaceutical company focused on photodynamic technologies in dermatology and
cancer, announces the publication of the results from the Phase 2b trial of
Visonac (methyl aminolevulinate 80mg/g), a novel topical acne treatment, in the
British Journal of Dermatology.
The Phase 2b trial was a multicenter, randomized, double-blind, placebo
controlled study in patients with severe acne vulgaris. Results showed Visonac®
produced a statistically significant reduction in inflammatory lesions and an
overall improvement in acne severity.
Dr David Pariser, Professor of Dermatology, Eastern Virginia Medical School,
former president of the American Academy of Dermatology and principal
investigator, commented: "These data are promising as they demonstrate Visonac's
potential as a significant advancement in the treatment of acne patients. There
is a high unmet medical need for novel, non-antibiotic alternative treatment
options in this patient population in whom the presence of multiple inflammatory
lesions takes a high toll on both their emotional and social well-being."
The study included 153 patients enrolled at 15 office-based dermatology
practices and hospitals in the US. In patients treated with Visonac, a
statistically significant reduction in inflammatory acne lesions of 43.8% was
achieved compared to 26.6% in the control group (p=0.003). Visonac also
demonstrated improvement in overall acne severity in a significant percentage of
patients as compared to control, 44.0% versus 26.4% (p=0.013), respectively.
Visonac was well tolerated and no serious adverse events were reported in the
study.
Kjetil Hestdal, President and CEO of Photocure, said: "We are pleased to see
this data published in such an esteemed journal, and view this as a testament to
the potential of Visonac as a new treatment option for the large number of
patients globally who suffer from severe acne. Visonac's high level of efficacy
coupled with the high patient tolerability demonstrated in the Phase 2b trial
are encouraging, and will aid in advancing to the next stage of development."
The full publication of the results from the Visonac phase 2b study, originally
completed in 2012, is available through the online publication in The British
Journal of Dermatology, "Photodynamic therapy with 80mg/g metyl aminolaevulinate
for severe facial acne vulgaris: a randomized vehicle-controlled study" at
http://onlinelibrary.wiley.com/doi/10.1111/bjd.14345/epdf
For further information, please contact:
Photocure
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: [email protected]
CFO Erik Dahl
Tel: +47 450 55 000, Email: [email protected]
About Photocure ASA
Photocure ASA, headquartered in Oslo, Norway, is a specialty pharmaceutical
company and world leader in photodynamic technology. Based on our unique
proprietary Photocure Technology(®) platform, Photocure develops and
commercializes highly selective and effective solutions in disease areas with
high unmet medical need, such as bladder cancer, HPV and precancerous cervical
lesions, colorectal cancer and skin conditions. Our aim is to provide solutions
that can improve health outcomes for patients worldwide. Photocure is listed on
the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at
www.photocure.com.
About Visonac
Acne is the single most common skin disease worldwide, and affects up to 85% of
all 12-24 year olds. There is a high unmet medical need for patients with acne,
where the current mainstay of treatment is oral antibiotics and/or retinoids.
Visonac is being developed as the first photodynamic therapeutic option for this
large patient population, which can easily and conveniently be administered in
dermatology offices. By avoiding the risks of increased antibiotic resistance
from long term exposure, and providing a highly tolerable alternative to
isotretinoin, Visonac has the potential to satisfy a high unmet medical need.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1973180]
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