Paratek Announces FDA Advisory Committee Date for Omadacycline
June 20 2018 - 9:05AM
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
Strain617-807-6688ir@ParatekPharma.com
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