Omadacycline Receives Qualified Infectious Disease Product Designation from FDA for an Additional Indication in Uncomplicated...
September 21 2017 - 08:00AM
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 ParatekParatek 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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