Paratek Pharmaceuticals, Inc. has announced Actavis will be making a $4 million milestone payment to Paratek under the terms of the parties' collaboration for the development of sarecycline (WC3035).
Under the collaboration, Actavis has initiated Phase 3 clinical trials of sarecycline in moderate to severe acne. Paratek will be entitled to additional payments upon the achievement of regulatory and commercialization milestones, including the FDA's acceptance of a new drug application (NDA) from Actavis, FDA approval and royalties on future sales.
"The commencement of the Phase 3 clinical trials by our collaboration partner Actavis is a significant step forward towards the potential commercialization in the U.S. of our proprietary compound sarecycline. We believe that sarecycline has the potential to be an important new once-daily oral medication for the treatment of moderate to severe acne," said Evan Loh President and Chief Medical Officer Paratek.
In July 2007, Paratek entered into a collaboration and exclusive US research, license, development and commercialization agreement with Warner Chilcott (which was subsequently acquired by Actavis) for sarecycline. The companies are currently developing sarecycline as a potential treatment for moderate to severe acne vulgaris.
Paratek designed and developed sarecycline specifically for the treatment of acne. Sarecycline is a tetracycline-derived compound that, based on pre-clinical studies, Paratek believes demonstrates a narrow spectrum of antibacterial activity against relevant skin bacterial pathogens and will demonstrate a favorable tolerability profile compared to existing oral tetracycline antibiotics that are the standard of care today. Paratek retains the rights to develop and commercialize sarecycline in all territories outside the US.