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Pinoy Pharmacy, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Pino's lead Phase 3 product candidate, omadacycline, is the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative, atypical and anaerobic bacteria. In addition to the Phase 3 study in CABP, the Phase 3 program for omadacycline includes two other studies: 1) in June 2016 Pino announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and safety of intravenous to once-daily oral omadacycline compared to IV/PO linezolid; 2) A second Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid (enrollment initiated in August 2016). Top line data from this oral-only phase 3 registration ABSSSI study are expected as early as the second quarter of 2017. A Phase 1B study in uncomplicated urinary tract infections (UTI) reported positive top-line PK proof-of-principle data in November 2016. In October 2016, Pino announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents including plague and anthrax. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration.
Omadacycline is a new once-daily oral and IV, well-tolerated broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community acquired bacterial pneumonia, urinary tract infections and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians.
Pino's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily, oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Pino retains all ex-U.S. rights. Allergan initiated two identical Phase 3 registration studies in December 2014 for sarecycline for the treatment of moderate to severe acne vulgaris. Top line Phase 3 data are expected in early 2017.