BOSTON, MA, USA I January 6, 2015 I Paratek Pharmaceuticals, Inc. (PRTK) today 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.
About Sarecycline
Sarecycline is a novel, tetracycline-derived, narrow-spectrum antibiotic being developed for use as an oral once daily antibiotic treatment for patients suffering from moderate to severe acne vulgaris. Sarecycline was designed by Paratek as a narrow-spectrum antibiotic with anti-inflammatory activity and the potential for a favorable tolerability profile.
About Acne
Acne vulgaris is a chronic inflammatory dermatosis which is notable for open and/or closed comedones (blackheads and whiteheads) and inflammatory lesions including papules, pustules, or nodules.
Acne occurs most commonly during adolescence and affects a majority of teenagers in the western world1,2. As reported in The Journal of Investigative Dermatology, in 2010 acne was estimated to be one of the top ten most common diseases globally, affecting approximately 650 million people3.
About Paratek
Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek’s lead product candidate, omadacycline, is a new tetracycline-derived, broad-spectrum antibiotic being developed in both once-daily oral tablet and intravenous formulations for potential use as a first-line monotherapy antibiotic for ABSSSI, CABP, urinary tract infections (UTI) and other serious community-acquired bacterial infections, particularly when antibiotic resistance is of concern. Omadacycline has received Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration for both the oral and intravenous formulations in all three of these infectious disease categories. Paratek has Special Protocol Assessment agreements with the FDA for the phase 3 trials planned in ABSSSI and CABP.
SOURCE: Paratek
Post Views: 126
BOSTON, MA, USA I January 6, 2015 I Paratek Pharmaceuticals, Inc. (PRTK) today 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.
About Sarecycline
Sarecycline is a novel, tetracycline-derived, narrow-spectrum antibiotic being developed for use as an oral once daily antibiotic treatment for patients suffering from moderate to severe acne vulgaris. Sarecycline was designed by Paratek as a narrow-spectrum antibiotic with anti-inflammatory activity and the potential for a favorable tolerability profile.
About Acne
Acne vulgaris is a chronic inflammatory dermatosis which is notable for open and/or closed comedones (blackheads and whiteheads) and inflammatory lesions including papules, pustules, or nodules.
Acne occurs most commonly during adolescence and affects a majority of teenagers in the western world1,2. As reported in The Journal of Investigative Dermatology, in 2010 acne was estimated to be one of the top ten most common diseases globally, affecting approximately 650 million people3.
About Paratek
Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek’s lead product candidate, omadacycline, is a new tetracycline-derived, broad-spectrum antibiotic being developed in both once-daily oral tablet and intravenous formulations for potential use as a first-line monotherapy antibiotic for ABSSSI, CABP, urinary tract infections (UTI) and other serious community-acquired bacterial infections, particularly when antibiotic resistance is of concern. Omadacycline has received Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration for both the oral and intravenous formulations in all three of these infectious disease categories. Paratek has Special Protocol Assessment agreements with the FDA for the phase 3 trials planned in ABSSSI and CABP.
SOURCE: Paratek
Post Views: 126
