Omadacycline Receives Qualified Infectious Disease Product Designation from FDA for an Additional Indication in Uncomplicated Urinary Tract Infections

• Uncomplicated UTIs are among the most common bacterial infections with few oral treatment options
  

BOSTON, Sept. 21, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today announced that its investigational antibiotic omadacycline has been granted an additional Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration (FDA) for the treatment of uncomplicated urinary tract infections (uUTI) for both the oral and the intravenous formulations. The QIDP designation, which is designed to speed the development of novel antibiotics for the treatment of pathogens with the potential to pose a serious threat to public health, provides an opportunity for more frequent interactions with the FDA, and a priority review of the marketing application for omadacycline in uUTI once submitted. Omadacycline has previously been granted QIDP designation for the treatment of community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI) and complicated urinary tract infections (cUTI).

“Omadacycline is one of very few antibiotics currently in late-stage development with the potential to address the significant challenges that currently exist in the treatment of urinary tract infections, including the need for a broad-spectrum, well-tolerated, once-daily oral antibiotic,” said Evan Loh, M.D., President, Chief Operating Officer and Chief Medical Officer of Paratek. “We expect to begin enrolling patients as early as December in a proof-of-concept Phase 2 study of omadacycline in uUTI, and an indication in this type of infection would broaden the opportunities for oral omadacycline in community-acquired infections.”

With its previously granted QIDP designations, the planned new drug applications for omadacycline for the treatment of ABSSSI and CABP will receive a priority review and, upon approval, the product will be granted an additional five years of market exclusivity, additive to Hatch-Waxman market exclusivity. A future NDA for uUTI would receive a priority review as well. The QIDP designations were granted to omadacycline under the provisions of the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The GAIN Act was intended to encourage development of new antibiotic agents for the treatment of serious or life-threatening infections.

Urinary tract infections are one of the most frequent bacterial infections affecting people in both the community and hospital settings,¹ diagnosed in an estimated 150 million people each year worldwide.² Escherichia coli (E. coli), the pathogen most often implicated in UTIs, is included in the World Health Organization’s list of bacteria of international concern, due to associated high rates of antimicrobial resistance.³ In fact, a recent meta-analysis found that 27 percent of cases of community-acquired and 38 percent of hospital-acquired E. coli UTIs are resistant to ciprofloxacin, one of the most commonly prescribed antibiotics for the treatment of these infections.⁴

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. The Company’s lead product candidate, omadacycline, is a new, once-daily oral and intravenous broad-spectrum antibiotic being developed for the treatment of serious community-acquired bacterial infections, including community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and urinary tract infections. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications of ABSSSI, CABP, uUTI and cUTI. Paratek has completed Phase 3 development activities for omadacycline in CABP and ABSSSI and is preparing to submit marketing applications in the United States and European Union. Paratek has licensed rights for omadacycline to Zai Lab for the greater China region, and retains all remaining global rights.

Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.

Paratek's second Phase 3 product candidate, sarecycline, is being developed by Allergan in the U.S. as a new once-daily oral therapy for the treatment of acne. Allergan has completed Phase 3 development activities for sarecycline and is preparing a new drug application for submission to the U.S. Food and Drug Administration. Paratek retains all ex-U.S. rights to sarecycline.

Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.

For more information, visit www.paratekpharma.com or follow @ParatekPharma on Twitter. 

¹ Laupland K, Ross T, Pitout J, Church D, Gregson D. Community-onset urinary tract infections: a population-based assessment. Infection, 2007;35:150-3.
² Gupta K., Hooton TM, Stamm WE. Increasing antimicrobial resistance and the management of uncomplicated community-acquired urinary tract infections. Ann Intern Med. 2001;135:41-50.
³ World Health Organization. Antimicrobial resistance: global report on surveillance. 2014. http://www.who.int/drugresistance/documents/surveillancereport/en/. Accessed 19 Sept 2017.
⁴ Fasugba O, Gardner A, Mitchell B, Mnatzaganian G. Ciprofloxacin resistance in community- and hospital-acquired Escherichia coli urinary tract infections: a systematic review and meta-analysis of observational studies. BMC Infectious Diseases. 2015; 15:545

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