Allergan plc, (NYSE:AGN), a leading global pharmaceutical company
and Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a
biopharmaceutical company focused on the development and
commercialization of innovative therapies based upon tetracycline
chemistry, announced that two (2) Phase 3 trials of sarecycline for
the treatment of moderate to severe acne met their 12 week primary
efficacy endpoints. Sarecycline is a once-daily, oral, narrow
spectrum tetracycline-derived antibiotic with anti-inflammatory
properties for the potential treatment of moderate to severe acne
in the community setting. Based on these data, Allergan plans
to file a New Drug Application (NDA) to the U.S. Food & Drug
Administration (FDA) in the second half of this year.
“The positive efficacy results observed in the pivotal phase 3
clinical trials indicate that sarecycline can be an effective
treatment option for patients with moderate to severe acne,” said
David Nicholson, Chief Global Research & Development Officer at
Allergan. “We look forward to submitting a new drug application for
sarecycline and bringing to market a potential new option for
physicians treating patients with acne.”
“We are pleased with the results of the sarecycline Phase 3
program and Allergan’s intention to move ahead with an NDA
submission for approval in the U.S. by the end of 2017,” said Evan
Loh, M.D., President, Chief Operating Officer and Chief Medical
Officer, Paratek. “Sarecycline is a narrow spectrum
antibiotic, which we believe can offer meaningful clinical benefits
for patients afflicted with acne.”
About SC1401 and SC1402Both SC1401 & SC1402
were designed to be replicative phase 3 randomized, multicenter,
double-blind, placebo-controlled studies to evaluate the efficacy
and safety of 1.5 mg/kg per day of sarecycline compared to placebo
in the treatment of moderate to severe acne.
The primary objective was to evaluate the efficacy and safety of
oral sarecycline 1.5 mg/kg per day compared to placebo in treating
inflammatory acne lesions in subjects with moderate to severe acne
based on Investigators Global Assessment (IGA) scale score and
inflammatory lesion counts. Patients were randomized (1:1) into two
treatment groups to receive either sarecycline tablets (60 mg, 100
mg and 150 mg, providing a dose of 1.5 mg/kg/day) or placebo once a
day for 12 weeks.
Sarecycline was statistically significantly (p < 0.004)
superior to placebo with respect to primary efficacy endpoints. The
most common adverse events (>2%) reported in the sarecycline
group were nausea (3.2%), nasopharyngitis (2.8%), and headache
(2.8%). The rate of discontinuation due to adverse events among
sarecycline-treated patients in the two studies combined was
1.4%.
About Allergan plc
Allergan plc (NYSE:AGN), headquartered in Dublin, Ireland, is a
bold, global pharmaceutical company and a leader in a new industry
model – Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing branded pharmaceuticals, devices
and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company’s
R&D model, which defines our approach to identifying and
developing game-changing ideas and innovation for better patient
care. This approach has led to Allergan building one of the
broadest development pipelines in the pharmaceutical industry with
70+ mid-to-late stage pipeline programs in development.
Our Company’s success is powered by our more than 16,000 global
colleagues’ commitment to being Bold for Life. Together, we build
bridges, power ideas, act fast and drive results for our customers
and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives every day.
For more information, visit Allergan's website at
www.Allergan.com.
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. Paratek's lead
product candidate, omadacycline, is the first in a new class of
tetracyclines known as aminomethylcyclines, with broad-spectrum
activity against Gram-positive, Gram-negative and atypical
bacteria. In June 2016, Paratek announced positive efficacy data in
a Phase 3 registration study in acute bacterial skin and skin
structure infections (ABSSSI) demonstrating the efficacy and safety
of intravenous (IV) to once-daily oral omadacycline compared to
linezolid. A Phase 3 registration study for
community-acquired bacterial pneumonia (CABP) comparing
IV-to-once-daily oral omadacycline to IV-to-oral moxifloxacin was
initiated in November 2015 and completed enrollment in January
2017. Paratek will report top-line data from this study early in
the second quarter of 2017. A Phase 3 registration study in ABSSSI
comparing once-daily oral-only dosing of omadacycline to
twice-daily oral-only dosing of linezolid was initiated in August
2016. Top-line data from this study are expected as early as
the second quarter of 2017. A Phase 1B study in uncomplicated
urinary tract infections (UTI) was initiated in May 2016 and
positive top-line PK proof-of-principle data were reported in
November 2016. The company plans to begin enrolling patients
in a proof-of-concept Phase 2 study in complicated UTI as early as
the fourth quarter of 2017. Omadacycline has been granted Qualified
Infectious Disease Product designation and Fast Track status by the
U.S. Food and Drug Administration for several indications.
In October 2016, Paratek announced a new cooperative research
effort with the U.S. Army Medical Research Institute of Infectious
Diseases (USAMRIID) to study omadacycline against pathogenic agents
causing infectious diseases of public health and biodefense
importance. These studies are designed to confirm dosing regimens
and assess efficacy of omadacycline against biodefense pathogens,
including Yersinia pestis (plague) and Bacillus anthracis
(anthrax).
Omadacycline is a new once-daily oral and IV, well-tolerated
broad spectrum antibiotic being developed for use as empiric
monotherapy for patients suffering from serious community-acquired
bacterial infections, such as acute bacterial skin and skin
structure infections, community-acquired bacterial pneumonia,
urinary tract infections and other community-acquired bacterial
infections, particularly when antibiotic resistance is of concern
to prescribing physicians.
Paratek's second Phase 3 product candidate, sarecycline, is a
well-tolerated, once-daily, oral, narrow spectrum
tetracycline-derived antibiotic with potent anti-inflammatory
properties for the potential treatment of acne and rosacea in the
community setting. Allergan owns the U.S. rights for the
development and commercialization of sarecycline. Paratek retains
all ex-U.S. rights. For more information,
visit www.paratekpharma.com.
Forward Looking StatementsThis press release
contains forward-looking statements including statements related to
our overall strategy, product candidates, clinical trials,
prospects and expected results, including statements about the
timing of advancing the clinical and regulatory program for
sarecycline. 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, which include, without
limitation, risks related to (i) our need for substantial
additional funding to complete the development and
commercialization of our product candidates, (ii) our ability to
raise the capital to do so, (iii) our ability to develop our drug
candidates for potential commercialization, (iv) the advancement of
omadacycline Phase 3 trials for ABSSSI and CABP, (v) the potential
for omadacycline to be successfully developed for use as a
first-line empiric monotherapy for patients suffering from serious
community-acquired bacterial infections, (vi) the potential of
omadacycline to become the primary antibiotic choice of physicians
for the treatment of serious community-acquired bacterial
infections, (vii) the ability of our supply chain to provide
adequate supply to satisfy our clinical and commercial demand
(viii) the potential use and effectiveness of sarecycline for the
treatment of acne and rosacea in the community setting, and (ix)
risks that sarecycline data to date and trends may not be
predictive of future results, risks related to the conduct of our
clinical trials, and risks that our clinical trials and product
candidates do not receive regulatory approval. 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,
2015, 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.
Allergan Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the difficulty of predicting the timing or
outcome of FDA approvals or actions, if any; the impact of
competitive products and pricing; market acceptance of and
continued demand for Allergan's products; difficulties or delays in
manufacturing; and other risks and uncertainties detailed in
Allergan's periodic public filings with the Securities and Exchange
Commission, including but not limited to Allergan's Annual Report
on Form 10-K for the year ended December 31, 2016. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
CONTACTS:
PARATEK:
Media:
Michael Lampe
Scient Public Relations
(484) 575-5040
michael@scientpr.com
Investors:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
ALLERGAN:
Media:
Mark Marmur
862-261-7558
Investors:
Karina Calzadilla
862-261-7558
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