Cempra to Present Solithromycin at FDA Antimicrobial Drugs Advisory Committee Meeting on November 4, 2016
August 30 2016 - 9:15AM
Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company
focused on developing antibiotics to meet critical medical needs in
the treatment of bacterial infectious diseases, today announced
that the U.S. Food and Drug Administration (FDA) has scheduled a
meeting of the Antimicrobial Drugs Advisory Committee on November
4, 2016 in Silver Spring, Maryland to discuss the safety and
efficacy of solithromycin to treat community-acquired bacterial
pneumonia (CABP).
Cempra conducted two pivotal Phase 3 global
registration trials of solithromycin. The first study was conducted
with solithromycin oral capsules, and the second study tested
intravenous (IV) solithromycin progressing to oral solithromycin.
Both Phase 3 studies met their primary endpoints that were aligned
with FDA guidance.
Solithromycin was granted qualified infectious
diseases product (QIDP) designation which entitled the new drug
applications (NDAs) to eight month priority reviews, resulting in
PDUFA dates of December 27, and December 28, 2016, respectively,
the oral and intravenous NDAs.
“Antimicrobial resistance is an urgent public
health threat and we believe that the strong data we have seen with
solithromycin in clinical trials supports its approval as a new IV
and oral antibiotic that would meet an important unmet need in the
treatment of both in-patient and out-patient CABP,” said
Prabhavathi Fernandes, Ph.D., president and chief executive officer
of Cempra.
“We look forward to the November 4 discussion
with the advisory committee, and continued dialogue with the FDA,
as we progress towards the solithromycin PDUFA dates at the end of
the year,” Fernandes added.
About Solithromycin
Solithromycin is a highly potent next-generation
macrolide which has activity against most macrolide-resistant CABP
pathogens. In vitro and in vivo studies have shown potent activity
against S. pneumoniae as well as an extended spectrum of activity
against community-acquired methicillin resistant S. aureus
(CA-MRSA), streptococci, haemophilus, enterococci, Mycobacterium
avium and in animal models of malaria. It is also active against
atypical bacteria, such as legionella, chlamydia, mycoplasma and
ureaplasma, and against gonococci and other organisms that cause
genitourinary tract infections. It is eight to 16 times more potent
than azithromycin against many bacteria and is active against
azithromycin-resistant strains. The activity of solithromycin
against resistant strains is driven by its ability to interact with
three sites on the bacterial ribosome, compared to the single
binding site of first and second generation macrolides.
About Community-Acquired Bacterial
Pneumonia
Community-acquired bacterial pneumonia (CABP) is
the number one cause of death from an infection, particularly in
the very young and in the elderly. CABP is one of the
most commonly diagnosed bacterial infections in
the U.S. with five to 10 million cases per year. Although
many strains of the primary CABP pathogen, Streptococcus
pneumoniae, are resistant to currently-approved macrolides,
this class of antibiotic remains among the most commonly
prescribed antibacterial drugs for CABP in both
hospital and community settings. Due to the rising threat of
microbial resistance, along with concerns over antibiotic
tolerability and impact on intestinal microflora,
new CABP treatments are needed. Antibiotic resistance is
a complex, emerging problem globally with potentially devastating
consequences for public health.
About Cempra, Inc.
Cempra, Inc. is a clinical-stage pharmaceutical
company focused on developing antibiotics to meet critical medical
needs in the treatment of bacterial infectious diseases. Cempra's
two lead product candidates are currently in advanced clinical
development. Solithromycin has been successfully evaluated in two
Phase 3 clinical trials for community-acquired bacterial pneumonia
(CABP) and applications for approval for both intravenous and oral
capsule formulations have been accepted for review by the FDA and
the EMA. Solithromycin is licensed to strategic commercial partner
Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings
Corporation, for certain exclusive rights in Japan. Solithromycin
is also in a Phase 3 clinical trial for uncomplicated urogenital
urethritis caused by Neisseria gonorrhoeae or chlamydia. Cempra is
contracted with BARDA for the development of solithromycin for
pediatric use. Three formulations, intravenous, oral capsules and a
suspension formulation are in a Phase 1b trial in children from
birth to 17 years of age. Fusidic acid is Cempra's second product
candidate, which is being developed for acute bacterial skin and
skin structure Infections (ABSSSI) and is also in an exploratory
study for chronic oral treatment of refractory infections in bones
and joints. Both products seek to address the need for new
treatments targeting drug-resistant bacterial infections in the
hospital and in the community. Cempra has also synthesized novel
macrolides for non-antibiotic uses such as the treatment of chronic
inflammatory diseases, endocrine diseases and gastric motility
disorders. Cempra was founded in 2006 and is headquartered in
Chapel Hill, N.C. For additional information about Cempra please
visit www.cempra.com.
Please Note: This press release
contains forward-looking statements regarding future events. These
statements are just predictions and are subject to risks and
uncertainties that could cause the actual events or results to
differ materially. These risks and uncertainties include, among
others: our and our strategic commercial partners' ability to
obtain FDA and foreign regulatory approval of our product
candidates, including solithromycin; our ability to commercialize
and launch, whether on our own or with a strategic partner, any
product candidate that receives regulatory approval; our ability to
produce and sell any approved products and the price we are able to
realize for those products; our ability to retain and hire
necessary employees and to staff our operations appropriately; the
unpredictability of the size of the markets for, and market
acceptance of, any of our products, including solithromycin and
fusidic acid; the costs, sources of funds, enrollment, timing,
regulatory review and results of our studies and clinical trials
and those of our strategic commercial partners; our need to obtain
additional funding and our ability to obtain future funding on
acceptable terms; our anticipated capital expenditures and our
estimates regarding our capital requirements; the possible
impairment of, or inability to obtain, intellectual property rights
and the costs of obtaining such rights from third parties; our
ability to compete in our industry; our dependence on the success
of solithromycin and fusidic acid; innovation by our competitors;
and our ability to stay abreast of and comply with new or modified
laws and regulations that currently apply or become applicable to
our business. The reader is referred to the documents that we file
from time to time with the Securities and Exchange Commission.
Contact:
John Bluth
Cempra, Inc.
+1 984 209 4534
jbluth@cempra.com
Investor Contact:
Robert Uhl
Westwicke Partners, LLC
+1 858 356 5932
robert.uhl@westwicke.com
Media Contact:
Melyssa Weible
Elixir Health PR
+1 201 723 5805
mweible@elixirhealthpr.com
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