Date: 2013-10-30
Type of information: Development agreement
Compound: Visonac®
Company: Photocure (Norway) Galderma (Switzerland)
Therapeutic area: Dermatological diseases
Type agreement:
Action mechanism: 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.
Disease: moderate to severe acne
Details: * On October 30, 2013, Photocure, a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, has announced an agreement with Galderma . 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.
Photocure has obtained a Special Protocol Agreement (SPA) from the 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.
Financial terms: Under the terms of the agreement, Photocure will pay $ 1.5 million to Galderma and has agreed to pay a further $ 1 million upon signing a future licensing or partnering deal.
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