Cempra Withdraws Solithromycin Marketing Authorization Application in Europe
March 28 2017 - 7:00AM
Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company
focused on developing differentiated anti-infectives for the acute
care and community settings to meet critical medical needs in the
treatment of infectious diseases, today announced that the company
has withdrawn its marketing authorization application (MAA) seeking
European Medicines Agency (EMA) approval of oral capsule and
intravenous formulations of solithromycin for the treatment of
community-acquired pneumonia in adults.
Based on the Day 120 questions Cempra received
from the EMA, the company believes additional data would be
required. By withdrawing the MAA at this time, Cempra will conserve
considerable financial resources, and it will allow the company to
align its strategy to provide additional data to both the EMA and
U.S. Food and Drug Administration (FDA) to support potential
approval.
“Our goal is to make solithromycin available in
the EU to address an important unmet medical need. We believe the
most efficient path to approval is to withdraw the MAA at this time
and to resubmit it with the additional data requested by the FDA,”
said David Zaccardelli, Pharm.D., acting chief executive officer of
Cempra.
If approved, solithromycin would be the first
new oral and IV antibiotic available in the EU in more than 15
years. According to the European Respiratory Society (ERS), more
than 3,000,000 cases of community-acquired pneumonia are diagnosed
each year in the EU, resulting in approximately 1,000,000
hospitalizations annually. The ERS notes that antibiotic resistance
is one of the major threats undermining the treatment of
respiratory infections.
About Cempra, Inc.
Cempra, Inc. is a clinical-stage pharmaceutical
company focused on developing differentiated anti-infectives for
the acute care and community settings to meet critical medical
needs in the treatment of infectious diseases. Cempra's two lead
product candidates are currently in advanced clinical development.
Solithromycin has been evaluated in two phase 3 clinical trials for
community-acquired bacterial pneumonia (CABP). Cempra is currently
seeking approval for both intravenous and oral capsule formulations
from the U.S. Food and Drug Administration. Solithromycin is
licensed to strategic commercial partner Toyama Chemical Co., Ltd.,
a subsidiary of FUJIFILM Holdings Corporation, for certain
exclusive rights in Japan. Cempra is contracted with BARDA for the
development of solithromycin for pediatric use and has commenced
enrollment in a global Phase 2/3 trial to evaluate the safety and
efficacy of solithromycin versus standard of care antibiotics in
children and adolescents from two months to 17 years of age.
Solithromycin is also in development for uncomplicated urogenital
urethritis caused by Neisseria gonorrhoeae or chlamydia. Fusidic
acid is Cempra's second product candidate, which has completed a
phase 3 trial comparing fusidic acid to linezolid in patients with
acute bacterial skin and skin structure infections (ABSSSI). Cempra
also has an ongoing exploratory study of fusidic acid 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 is also studying solithromycin for ophthalmic
conditions and has 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 ability to address the issues identified by the FDA in
the complete response letter relating to our new drug applications
for solithromycin for community acquired bacterial pneumonia; our
anticipated capital expenditures and our estimates regarding our
capital requirements, including the costs of addressing the
complete response letter; our ability to obtain FDA and
foreign regulatory approval of solithromycin as a treatment for
community-acquired bacterial pneumonia; our and our strategic
commercial partners’ ability to obtain FDA and foreign regulatory
approval of our product candidates; and results of our and our
strategic commercial partners' pre-clinical studies and clinical
trials, which are not predictive of results from subsequent
clinical trials for any possible therapy. 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.
(984) 209-4534
jbluth@cempra.com
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