- Rolling NDA submission underway for omadacycline in pneumonia and skin infections
- Omadacycline Phase 2 program underway for the treatment of urinary tract infections
- $5 million milestone payment earned from Allergan with Seysara™ NDA acceptance
BOSTON, Jan. 03, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry, today announced recent progress across its product pipeline. Paratek has initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for the indications of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) and is on track to submit the final components during the first quarter of 2018. Rolling submission allows completed portions of an NDA to be reviewed by the FDA on an ongoing basis. The FDA had previously granted omadacycline Qualified Infectious Disease Product designation and Fast Track designation, which provides for a Priority Review of the NDA, once accepted.
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 $5 million milestone payment from Allergan under the terms of the parties’ collaboration for the development of Seysara™ (sarecycline), a new, narrow-spectrum oral antibiotic for the treatment of moderate to severe acne. The milestone payment became payable upon the FDA’s acceptance of Allergan’s NDA for Seysara, announced in December 2017. Allergan plans to commercialize Seysara in the U.S. Paratek retains all ex-U.S. rights to the product.
“With our product candidates now either approaching or under review with the FDA and a new phase of our omadacycline development program underway, we are making substantial progress towards our goal of bringing important, novel therapies to patients and maximizing the value of our portfolio,” said Evan Loh, MD, President, COO & CMO of Paratek. “Based on the clinical trial data and what we’ve heard from doctors, we believe omadacycline – particularly having both oral and intravenous formulations – plus Seysara, will help address urgent and growing needs for new modernized tetracycline antibiotics across multiple clinical settings.”
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. 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 has initiated its New Drug Application to the U.S. FDA in the United States. 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, 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 December 2017. Paratek retains all ex-U.S. rights to Seysara.
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 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.
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