Paratek Announces FDA Advisory Committee Date for Omadacycline
BOSTON, June 20, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today announced that a meeting of the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for August 8, 2018 to review the Company's New Drug Applications (NDAs) for once-daily, oral and intravenous omadacycline. Omadacycline is under review for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
The FDA accepted Paratek’s NDA for priority review in April 2018. In the NDA acceptance letter, the FDA noted that it was planning to hold an advisory committee meeting. The target action date under the Prescription Drug User Fee Act (PDUFA) is early October 2018.
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 (UTI). 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, and UTI. Paratek has completed Phase 3 development activities for omadacycline in CABP and ABSSSI, and its New Drug Applications to the U.S. FDA have been accepted for priority review. The Company plans to submit a marketing authorization in the European Union in the second half of this year. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in 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 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. FDA in December 2017. 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.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, product candidates, prospects, potential and expected results, including statements about the development, launch and commercialization of omadacycline, the potential for omadacycline to treat ABSSSI, CABP, UTI and other serious community-acquired bacterial infections, the prospect of omadacycline providing broad-spectrum activity, our ability to obtain regulatory approval of omadacycline and our anticipated transition to a commercial stage organization. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as “potential,” “prospective,” “prepare” 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, 2017, 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.
CONTACT:
Investor and Media Relations:
Ben Strain
617-807-6688
ir@ParatekPharma.com
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