Paratek Pharmaceuticals Announces Modification of BARDA Contract to Advance the Development of NUZYRA® (omadacycline) for Post-Exposure Prophylaxis (PEP) and Treatment of Pulmonary Anthrax
10 Julho 2023 - 9:00AM
Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel life-saving therapies for
life-threatening diseases and other public health threats for
civilian, government and military use, today announced a
modification to its Project BioShield contract with the Biomedical
Advanced Research and Development Authority (BARDA), part of the
Administration for Strategic Preparedness and Response (ASPR)
within the U.S. Department of Health and Human Services. The
modification provides new development milestones associated with
the achievement of specific anthrax development milestones for the
next BARDA procurement of NUZYRA® (omadacycline).
BARDA and Paratek have agreed the next procurement of NUZYRA
anthrax treatment courses will be split into two equal procurements
based on the achievement of specific development milestones toward
both treatment and post-exposure prophylaxis (PEP) indications of
pulmonary anthrax.
The first of these procurements will be triggered by the
delivery of positive top-line data from a dose-ranging efficacy
study for PEP of inhalation anthrax in non-human primates (NHPs).
The company expects this data to be available in the first quarter
of 2024. The second of these procurements will be triggered by
BARDA’s receipt of positive top-line data from a combination of two
studies, a dose-ranging efficacy study in NHPs and a pivotal
efficacy study in rabbits for the treatment of inhalation anthrax,
which the company anticipates could be available as early as the
fourth quarter of 2024. The trigger for the final procurement of
NUZYRA continues to be Paratek’s receipt of sNDA approval from the
FDA for the treatment of inhalation anthrax. The company will
provide further specificity on these timelines as the anthrax
development program progresses.
“We thank BARDA for the continued funding of our comprehensive
NUZYRA development program for PEP and treatment of pulmonary
anthrax and are pleased to announce these important contract
modifications to further build on our promising in vitro and in
vivo animal data generated to date,” said Randy Brenner, Paratek’s
chief development and regulatory officer. “Our anthrax program
remains vitally important since antimicrobial resistance and
bioterrorism continue to be public health and national security
risks.”
In December 2019, BARDA awarded Paratek a contract
(75A50120C00001) that is now valued at up to approximately $304
million. In addition to supporting the development of NUZYRA for
both the treatment and prophylaxis of pulmonary anthrax, this
contract supports the U.S. onshoring of NUZYRA and manufacturing
security requirements; FDA post-marketing requirements associated
with the initial NUZYRA approval; and the procurement of up to
10,000 treatment courses of NUZYRA for treatment of anthrax.
About Paratek Pharmaceuticals, Inc.Paratek
Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical
company focused on the development and commercialization of novel
life-saving therapies for life-threatening diseases or other public
health threats for civilian, government and military use.
The company’s lead commercial product, NUZYRA® (omadacycline),
is a once-daily oral and intravenous antibiotic available in the
United States for the treatment of adults with community-acquired
bacterial pneumonia (CABP) and acute bacterial skin and skin
structure infections (ABSSSI). Paratek has a collaboration
agreement with Zai Lab for the development and commercialization of
omadacycline in the greater China region and retains all remaining
global rights.
Paratek is also conducting a Phase 2b study with NUZYRA in a
rare disease, non-tuberculous mycobacterial (NTM) pulmonary
disease, caused by Mycobacterium abscessus complex. Paratek
estimates this opportunity represents a potential $1 billion
addressable market in the United States. Paratek exclusively
licensed U.S. rights and rights to the greater China territory for
Seysara® (sarecycline), a once-daily oral therapy for the treatment
of moderate to severe acne vulgaris, to Almirall, LLC. Paratek
retains the development and commercialization rights for
sarecycline in the rest of the world.
In 2019, Paratek was awarded a contract from the Biomedical
Advanced Research and Development Authority, part of the
Administration for Strategic Preparedness and Response within the
U.S. Department of Health and Human Services, now valued at up to
$304 million, to support the development of omadacycline for
pulmonary anthrax and the U.S.-based commercial manufacturing of
NUZYRA.
For more information, visit www.ParatekPharma.com or
follow us on LinkedIn and Twitter.
About NUZYRANUZYRA (omadacycline) is a novel
once-daily antibiotic with both oral and intravenous (IV)
formulations for the treatment of community-acquired bacterial
pneumonia (CABP) and acute bacterial skin and skin structure
infections (ABSSSI). A modernized tetracycline, NUZYRA is
specifically designed to overcome tetracycline resistance and
exhibits activity across a spectrum of bacteria, including
Gram-positive, Gram-negative, atypicals, and other drug-resistant
strains.
Please see full Prescribing Information for NUZYRA at
www.NUZYRA.com.
Forward-Looking StatementsThis press release
contains forward-looking statements including statements related to
our overall BARDA contract, our execution under the contract, and
potential utility of NUZYRA to address potential health
emergencies, including pandemics. 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," "expect," "look forward," "anticipate," "continue,"
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,
2022 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.
CONTACTS:
For Investors:PJ Kelleher LifeSci Advisors
pkelleher@lifesciadvisers.com 617-430-7579
For Media:Christine FanelleScient
PRChristine@ScientPR.com215-595-5211
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