Oslo, Norway, October 30, 2013: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces an agreement with Galderma S.A. which enables Photocure to explore partnerships for development and commercialization prior to initiation of the phase 3 clinical program. Visonac® (methyl aminolevulinate) is in development for the treatment of moderate to severe acne. Visonac has successfully completed a phase 2b clinical trial and it is now phase 3 ready.
Under an agreement signed in 2009, Galderma had certain rights to the Visonac product which commenced following completion of phase 3 development. Photocure has successfully renegotiated these terms which enables pursuit of the optimum development and commercialization strategy for Visonac including exploration of potential partnerships at a significantly earlier stage.
Visonac is a novel photodynamic therapy for the treatment of moderate to severe inflammatory acne. Positive results of the phase 2b study in acne with Visonac demonstrated a statistically significant reduction in inflammatory lesions and overall improvement in acne severity. Visonac was well tolerated and no serious adverse events were reported in the study.
Photocure has obtained a Special Protocol Agreement (SPA) from the US FDA on the design of the phase 3 clinical registration program for Visonac. The SPA defines the size, design and analysis of clinical trials that will form the primary basis of approval. Additionally in August 2013, Photocure received a notice of allowance for its acne patent in USA. Earlier patents of this acne patent family have been granted in other major markets including Europe, China, and Japan. This patent family protects the use of Visonac for the treatment of acne until 2025.
Kjetil Hestdal, President and CEO of Photocure, said: “Reaching agreement with Galderma represents an important step in securing the optimum strategy in the short term for the further development and commercialization of Visonac. Visonac offers a promising new treatment option for the large number of patients globally who suffer from moderate to severe acne. The potential of Visonac has been demonstrated in recent clinical studies and we will now progress discussions with potential partners on the further development of this exciting product.”
Under the terms of the agreement, Photocure will pay USD 1.5 million to Galderma and has agreed to pay a further USD 1 million upon signing a future licensing or partnering deal.
For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: firstname.lastname@example.org
CFO Erik Dahl
Tel: +47 450 55 000, Email: email@example.com
Mary Clark, Hollie Vile, Supriya Mathur
Tel: +44 20 3440 5653, Email: firstname.lastname@example.org
All trademarks mentioned in this release are protected by law and registered trademarks of Photocure.
Visonac (methyl aminolevulinate 80mg/g) is in development for the treatment of moderate to severe acne. 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 moderate to severe acne, where the current mainstay of treatment is oral antibiotics and/or retinoids. The value of this segment globally is estimated at USD 900 million annually. 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 better tolerated alternative than systemic isotretinoin (retinoid; vitamin A derivative), Visonac has the potential to satisfy a high unmet medical need.
Visonac cream is applied to the acne area, and after a short incubation time, the skin is illuminated with red light. The mechanism of action is two fold: an antibacterial effect against P. Acnes and a reduction of sebum production by the sebaceous glands.