Cempra's Solithromycin Demonstrates Safety and Tolerability in Patients With Chronic Liver Disease

Cempra's Solithromycin Demonstrates Safety and Tolerability in Patients With
Chronic Liver Disease

Pharmacokinetic Analyses of Hepatic Impairment Study Show no Dosage
Adjustments Necessary to Compensate for Decreased Liver Function

CHAPEL HILL, N.C., Sept. 5, 2013 (GLOBE NEWSWIRE) -- Cempra, Inc.
(Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing
differentiated antibiotics to meet critical medical needs in the treatment of
bacterial infectious diseases, today announced that solithromycin demonstrated
safety and tolerability in patients with mild to severe chronic liver disease.
The pharmacokinetic analyses also showed that no dosage adjustments to
compensate for decreased liver function were necessary in this patient
population.

"Solithromycin was well-tolerated in patients with chronic liver disease, both
compensated and uncompensated, and no significant differences in safety from
the age- and weight-matched healthy control group were observed," said Brian
Jamieson, M.D., senior director of clinical research at Cempra. "Based on the
pharmacokinetic analyses, no dosage adjustments were needed in these patients
with mild to severe chronic liver disease. Solithromycin continues to
differentiate itself against current treatments for community-acquired
bacterial pneumonia, sexually-transmitted diseases and other serious
infections."

In this hepatic impairment study, 24 patients with chronic liver disease,
eight with mild disease, eight with moderate disease and eight with severe
disease, were given a five-day course of solithromycin dosed as 800 mg on day
1 followed by 400 mg once-daily on days two through five. The pharmacokinetics
of solithromycin in these three patient groups were evaluated and compared to
a matched healthy control cohort given the same regimen. Solithromycin is
currently in a global Phase 3 clinical trial in patients with
community-acquired bacterial pneumonia (CABP), to evaluate both the safety and
efficacy in this patient population.

"Solithromycin, our differentiated molecule, has shown a favorable safety
profile throughout its clinical testing to date in healthy volunteers and in
CABP patients," said Prabhavathi Fernandes, Ph.D., president and chief
executive officer of Cempra. "We believe that the U.S. Food and Drug
Administration's requirements for the CABP safety database will be met through
our Phase 3 clinical trials and previous studies."

About Cempra, Inc.

Founded in 2006, 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
(CEM-101) is in a Phase 3 clinical trial for community-acquired bacterial
pneumonia (CABP) and is licensed to strategic partner Toyama Chemical Co.,
Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive
rights in Japan. TAKSTA™ (CEM-102) is Cempra's second product candidate
currently in a Phase 2 clinical trial for prosthetic joint infections. Both
seek to address the need for new treatments targeting drug-resistant bacterial
infections in the hospital and in the community. The company also intends to
use its series of proprietary lead compounds from its novel macrolide library
for uses such as the treatment of chronic inflammatory diseases, endocrine
diseases and gastric motility disorders. Additional information about Cempra
can be found at 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: the results,
timing, costs and regulatory review, and other analyses, of our studies and
clinical trials; 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; our ability
to obtain FDA approval of our product candidates; our dependence on the
success of solithromycin and Taksta; and innovation by our competitors. The
reader is referred to the documents that we file from time to time with the
Securities and Exchange Commission.

CONTACT: Investor and Media Contacts:
         Robert E. Flamm,
         Ph.D. Russo Partners, LLC
         (212) 845-4226
         Robert.flamm@russopartnersllc.com
        
         Andreas Marathovouniotis
         Russo Partners LLC
         (212) 845-4235
         Andreas.marathis@russopartnersllc.com
 
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