Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that
new data from its omadacycline clinical and microbiology programs
will be presented at IDWeek 2017 taking place in San Diego from
October 4 – 8. In addition to the poster presentations, Paratek’s
Vice President of Clinical Development and Medical Affairs, Paul
McGovern, M.D., will provide an overview of omadacycline during the
New Antibiotics: What’s in the Pipeline symposium. Paratek is a
biopharmaceutical company focused on the development and
commercialization of innovative therapies based upon tetracycline
chemistry.
“Our clinical program continues to demonstrate a compelling
profile for once-daily oral and IV omadacycline and
underscores our commitment to bringing this new antibiotic
treatment option to physicians and patients given the tremendous
need, particularly for new safe and effective oral options,” said
Evan Loh, M.D., President, Chief Operating Officer, and Chief
Medical Officer, Paratek. “As we move closer to initiating our
rolling submission in December of this year, we remain committed to
sharing data about the utility of omadacycline with prescribers who
are in need of new, effective oral agents to combat serious
community-acquired infections.”
Thursday, October 5 at 2:36 p.m. – 2:45 p.m. PDT (11:36
a.m. – 11:45 a.m. EDT)Symposium: New
Antibiotics: What’s in the Pipeline
Omadacycline, the First AminomethylcyclineSession #:
861; Presenter: P. McGovern
Friday, October 6, 2017 at 12:30
p.m. – 2:00 p.m. PDT (9:30 a.m. – 11:00
a.m. EDT)Poster Abstract Session: Expanded Spectrum - New
Antimicrobial Susceptibility Testing
In Vitro Activity of Omadacycline and Comparator Compounds
against Gram-positive Isolates Collected in the USA During 2016 as
Part of a Global Surveillance Program Poster #:
1223; Presenter: R. Flamm
Poster Abstract Session: Preclinical Study with New Antibiotics
and Antifungals
In vivo Pharmacodynamic Evaluation of Omadacycline (PTK 0796)
against Staphylococcus aureus (SA) in the Murine Thigh Infection
Model Poster #: 1531;
Presenter: A. Lepak
Saturday, October 7, 2017 at 12:30 p.m. – 2:00 p.m. PDT
(9:30 a.m. – 11:00 a.m. EDT)Poster Abstract Session:
Clinical Study with New Antibiotics and Antifungals
Efficacy and Safety of Omadacycline in Chronic Kidney Disease
(CKD) Patients with Acute Bacterial Skin and Skin Structure
Infections (ABSSSI): A Subgroup Analysis from the OASIS
TrialPoster #: 1834; Presenter:
T. File
Efficacy and Safety of Omadacycline in Patients with Acute
Bacterial Skin and Skin Structure Infections (ABSSSI) and High Body
Mass Index or Type 2 Diabetes: A Subgroup Analysis from the OASIS
TrialPoster #: 1838;
Presenter: M. Wilcox
A Pharmacometric Comparison of Omadacycline and Tigecycline
Epithelial Lining Fluid (ELF) PenetrationPoster #:
1850; Presenter: E. Lakota
Analysis of the Microbiological data from the Omadacycline (OMC)
Phase 3 Community-Acquired Bacterial Pneumoniae (CABP) trial: The
OPTIC studyPoster #: 1875;
Presenter: J. Steenbergen
A Phase 3 Randomized, Double-Blind, Multi-Center Study to
Compare the Safety and Efficacy of IV to Oral Omadacycline to
Moxifloxacin for the Treatment of Adult Subjects with CABP (The
OPTIC Study)Poster #: 1883;
Presenter: I. Mitha
Efficacy and Safety of Omadacycline in Intravenous Drug Using
(IVDU) and Hepatitis C-Positive (HCV+) Patients with Acute
Bacterial Skin and Skin Structure Infections (ABSSSI): A Subgroup
Analysis from the OASIS TrialPoster #:
1885; Presenter: C. Ohl
Cardiac Safety of Omadacycline in the IV/oral Phase 3 Acute
Bacterial Skin and Skin Structure Infection (ABSSSI) and in the
IV/oral Phase 3 Community-acquired Bacterial Pneumonia (CABP)
StudiesPoster #: 1886;
Presenter: P. McGovern
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 is preparing to submit marketing applications in
the United States and European Union. 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, 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 sarecycline and is
preparing a new drug application for submission to the U.S.
Food and Drug Administration. 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 StatementsThis 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.
CONTACTS:
Media
Relations: |
|
Investor
Relations: |
Michael Lampe |
|
Hans Vitzthum |
(484) 575-5040 |
|
LifeSci Advisors,
LLC. |
michael@scientpr.com |
|
212-915-2568 |
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