Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that
two cost benefit analyses presented at the annual meeting of the
European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID 2017) in Vienna, Austria, highlight the potential of
IV-to-oral omadacycline to confer cost savings relative to the
current standard of care for the treatment of patients with acute
bacterial skin and skin structure infection (ABSSSI).
ABSSSI is responsible for more than 750,000 hospitalizations per
year (latest data available, 2011), representing a 17.3% increase
in hospitalized ABSSSI patients from 2005 to 2011. On
average, inpatient costs per ABSSSI patient range between $6,000 to
$13,000, with multi-day room and board expenses comprising 50% of
total costs. Patients with ABSSSIs typically spend 4-5 days
in the hospital and each hospital day costs upwards of
$1,400. Data also suggest that nearly half of patients
admitted for the treatment of ABSSSIs have zero or few
comorbidities and many of these patients can be safely and
effectively managed in the outpatient setting.
The first analysis evaluated the potential economic impact of
IV-to-oral omadacycline among hospitalized ABSSSI patients with ≥2
comorbidities and no life-threatening conditions. Previous
studies have shown that IV-to-oral antibiotics like omadacycline
can reduce hospital length of stay by a few days relative to IV
antibiotic treatments without an oral equivalent stepdown option.
By facilitating a 1-2 hospital stay reduction (model assumption),
the conceptual healthcare decision models from both the hospital
and third party payers’ perspective highlighted the potential of
omadacycline to confer substantial cost savings relative to the
current inpatient standard of care, even with daily omadacycline
cost upwards of $400-$500 a day.
The second decision-analytic, cost-minimization model was
constructed from the hospital perspective to compare the costs of
inpatient treatment with IV vancomycin (current standard of care)
versus outpatient omadacycline for the treatment of ABSSSI patients
with few or no comorbidities presenting to the emergency
department. Conservatively assuming that treatment with
inpatient treatment with vancomycin is ~$6500 U.S. dollars,
switching an individual patient from vancomycin inpatient treatment
to outpatient omadacycline was estimated to save $2,500 to $4,000
per patient, depending on use of observation unit and inputted
daily cost of omadacycline. It was also estimated that up to
48% of omadacycline patients discharged home from the emergency
department could be subsequently admitted to the hospital after 3
days of omadacycline oral while maintaining budget neutrality.
“The most direct approach to reducing the financial burden for
the treatment of patients with skin and skin structure infection is
to avoid admitting patients that that can be safely and effectively
managed in the outpatient setting. Failing this, the next approach
to reduce healthcare costs associated with the management of
admitted ABSSSIs patients is to facilitate the patients early
discharge onto oral antibiotics as soon as they become stable,”
said Tom Lodise, Pharm.D., Ph.D., Professor, Albany College of
Pharmacy and Health Sciences. “The results of today’s cost
modeling studies are encouraging as they suggest that IV-to-oral
omadacycline, if approved, has the potential to create savings for
both hospitals and payers.”
About Paratek Pharmaceuticals, Inc.
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 the first in a
new class of tetracyclines known as aminomethylcyclines, with
broad-spectrum activity against Gram-positive, Gram-negative and
atypical bacteria. Omadacycline is a new, once-daily oral and
intravenous 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. 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.
In June 2016, Paratek announced positive efficacy data in a
Phase 3 registration study in acute bacterial skin and skin
structure infections (ABSSSI) demonstrating the efficacy, general
safety and tolerability of intravenous (IV) to once-daily oral
omadacycline compared to linezolid. In April 2017, Paratek
announced positive efficacy data in a Phase 3 registration study in
community-acquired bacterial pneumonia (CABP) demonstrating the
efficacy, general safety and tolerability of IV to once-daily oral
omadacycline compared to moxifloxacin. A Phase 3 registration study
in ABSSSI comparing once-daily oral-only dosing of omadacycline to
twice-daily oral-only dosing of linezolid was initiated in August
2016. Top-line data from this study are expected as early
as the end of June. The Company plans to submit its new drug
application (NDA) in the U.S. as early as the first quarter of 2018
with an EMA submission later in 2018.
In addition to its Phase 3 program for omadacycline, a Phase 1B
study in uncomplicated urinary tract infections (UTI) was initiated
in May 2016 and positive top-line PK proof-of-principle data was
reported in November 2016. The Company plans to begin enrolling
patients in a proof-of-concept Phase 2 study of omadacycline in
acute pyelonephritis, the most common subset of complicated urinary
tract infections, as early as December 2017.
In October 2016, Paratek announced a research agreement with
the U.S. Department of Defense to explore the utility of
omadacycline 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 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. Paratek retains
all ex-U.S. rights. Allergan and Paratek reported positive results
from two identical Phase 3 registration studies of sarecycline for
the treatment of moderate to severe acne vulgaris in March
2017. Allergan has publicly announced plans to submit an NDA
in the U.S. in the second half of 2017.
For more information, visit www.paratekpharma.com.
Forward Looking Statements
This press release contains forward-looking statements including
statements related to our overall strategy, product candidates,
clinical studies, prospects and expected results, including
statements about the timing of advancing omadacycline and otherwise
preparing for clinical studies, the timing of enrollment in our
clinical studies and of our reporting of the results of such
studies, the potential for omadacycline to serve as an empiric
monotherapy treatment option for patients suffering from ABSSSI,
CABP, UTI, and other bacterial infections when resistance is of
concern, the prospect of omadacycline providing broad-spectrum
activity, and our ability to obtain regulatory approval of
omadacycline. All statements, other than statements of historical
facts, included in this press release are forward-looking
statements, and are identified by words such as "advancing,"
"believe," "expect," "well positioned," "look forward,"
"anticipated," "continued," and other words and terms of similar
meaning. These forward-looking statements are based upon our
current expectations and involve substantial risks and
uncertainties. We may not actually achieve the plans, carry out the
intentions or meet the expectations or projections disclosed in our
forward-looking statements and you should not place undue reliance
on these forward-looking statements. Our actual results and the
timing of events could differ materially from those included in
such forward-looking statements as a result of these risks and
uncertainties. These and other risk factors are discussed under
"Risk Factors" and elsewhere in our Annual Report on Form 10-K for
the year ended December 31, 2016, and our other filings with the
Securities and Exchange Commission. We expressly disclaim any
obligation or undertaking to update or revise any forward-looking
statements contained herein.
CONTACTS:
Media Relations:
Michael Lampe
(484) 575-5040
michael@scientpr.com
Investor Relations:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
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