VIENNA, Austria, April 24, 2017 (GLOBE NEWSWIRE) -- 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.