News ReleaseView printer-friendly version << Back
Paratek Provides Update on Pipeline Progress
- Rolling NDA submission underway for omadacycline in pneumonia and skin infections
- Omadacycline Phase 2 program underway for the treatment of urinary tract infections
$5 millionmilestone payment earned from Allerganwith Seysara™ NDA acceptance
In addition, The Company has initiated sites for the first of the two planned Phase 2 studies evaluating its investigational antibiotic, omadacycline, for the treatment of urinary tract infections (UTI). This first study will evaluate the safety, tolerability and pharmacokinetics of omadacycline in female patients with uncomplicated UTI. The second study, which will be initiated later this year, will evaluate the safety, tolerability and pharmacokinetics of omadacycline in patients with acute pyelonephritis. The Company plans to enroll approximately 200 patients in each study at multiple sites. Additional information about Paratek’s Phase 2 studies of omadacycline will be posted on ClinicalTrials.gov.
Paratek also announced that it has earned a
“With our product candidates now either approaching or under review with the
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, Seysara™ (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 Seysara and its new drug application was accepted for review by the U.S. Food and Drug Administration in
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.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential 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 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
|Media Relations:||Investor Relations:|
|Michael Lampe||Hans Vitzthum|
|(484) 575-5040||LifeSci Advisors, LLC.|