FDA Advisory Committee Recommends Approval of Paratek’s Omadacycline
August 08 2018 - 2:20PM
-- Positive vote for both the skin infections and
pneumonia indications --
Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced that
the Antimicrobials Drug Advisory Committee of the U.S. Food and
Drug Administration voted in favor of the approval of intravenous
(IV) and oral omadacycline for the treatment of acute bacterial
skin and skin structure infections (ABSSSI) (17-1) and
community-acquired bacterial pneumonia (CABP) (14-4).
Omadacycline is a modernized tetracycline being developed as a
once-daily IV and oral, broad spectrum antibiotic for the treatment
of serious community-acquired infections.
“Omadacycline has the potential to help address the urgent and
growing need for new antibiotics to treat serious
community-acquired infections. With once-daily dosing and
bioequivalent IV and oral formulations, omadacycline may help
facilitate early discharge from the hospital or, in other cases,
allow for safe and effective treatment in the outpatient setting,”
said Michael F. Bigham, Chairman and CEO, Paratek. “Today’s
recommendations from the Advisory Committee move us one step closer
to making this important new treatment option available to patients
and physicians. We look forward to working with the FDA as it
considers the comments from the committee members and completes its
review of the omadacycline new drug applications.”
As part of its recommendation, the Advisory Committee considered
data from the omadacycline global development program, which
included three completed Phase 3 studies evaluating the safety and
efficacy of the once-daily IV and oral formulations of omadacycline
for the treatment of ABSSSI and CABP. In all three studies,
omadacycline met all primary and secondary efficacy outcomes
designated by the FDA and was generally safe and well-tolerated. A
total of nearly 2,000 adult patients received omadacycline
administered once-daily as part of the clinical trials. The
Advisory Committee was asked to vote on whether the data provided
substantial evidence of the safety and effectiveness of
omadacycline in both ABSSSI and CABP.
The Prescription Drug User Fee Act (PDUFA) date for both new
drug applications is in early October 2018.
About Omadacycline
Omadacycline is a novel investigational antibiotic with both
once-daily intravenous (IV) and oral formulations for the treatment
of community-acquired bacterial pneumonia (CABP), acute bacterial
skin and skin structure infections (ABSSSI), and urinary tract
infections (UTI). A modernized tetracycline, omadacycline is
specifically designed to overcome tetracycline resistance and
exhibits activity across a broad spectrum of bacteria, including
Gram-positive, Gram-negative, anaerobes, atypical bacteria, and
other drug-resistant strains.
Omadacycline has been granted Qualified Infectious Disease
Product designation and Fast Track status by the U.S. Food and Drug
Administration (FDA) for the target indications of CABP, ABSSSI,
and UTI. The FDA has accepted the New Drug Applications for CABP
and ABSSSI and has granted omadacycline priority review. Paratek is
also preparing a marketing authorization application in the
European Union. 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.
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
broad-spectrum once-daily intravenous and oral antibiotic being
developed for the treatment of serious community-acquired bacterial
infections, including community-acquired bacterial pneumonia, acute
bacterial skin and skin structure infections, and urinary tract
infections.
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. FDA in
December 2017. The PDUFA date for SEYSARA is in the second half of
2018. 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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