Cempra to Present Data at ICAAC on Solithromycin's (CEM-101) Activity Against a Broad Range of Pathogens Including Four Proposed

Cempra to Present Data at ICAAC on Solithromycin's (CEM-101) Activity Against
a Broad Range of Pathogens Including Four Proposed or Designated by the Food
and Drug Administration as Qualified Infectious Disease Pathogens (QIDP) Under
the Generating Antibiotic Incentives Now (GAIN) Act

CHAPEL HILL, N.C., Sept. 10, 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 infections, today announced that it will present data at the
Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in
Denver, Colorado, showing the marked activity of solithromycin against a broad
range of pathogens including four proposed or designated by the Food and Drug
Administration (FDA) as qualified infectious disease pathogens (QIDP) under
the Generating Antibiotic Incentives Now (GAIN) Act.

"Solithromycin, our fourth-generation macrolide, is an antibiotic candidate
with activity against important bacterial pathogens and with potential use in
a broad range of clinical settings," said Prabhavathi Fernandes, Ph.D., chief
executive officer of Cempra. "Data presented at this year's ICAAC highlight
solithromycin's activity against five important pathogens, four of which are
proposed or designated as QIDPs under the GAIN Act. These data demonstrate
that solithromycin continues to differentiate itself from other antibiotics
and support its development for a number of important infectious disease

Abstract C2-101: 12:00 p.m. CMT, Sept. 10: Activity of Solithromycin (SOL)
Against S. pneumoniae (SP) Clinical Strains with Non-susceptibility (NS) and
Resistance (R) [EUCAST Interpretative Criteria] To Penicillin G (PEN),
Amoxicillin (AMX), Ceftriaxone (CRO), Moxifloxacin (MXF), Levofloxacin (LVX)
And Ceftaroline (CPT)

P. M. Tulkens, M. P. Van der Linden, F. Van Bambeke, R. Vanhoof

  *In vitro activity of solithromycin was assessed against 426 respiratory
    tract S. pneumoniae (a proposed QIDP) infection isolates that were
    resistant to beta-lactams and fluoroquinolones
  *Solithromycin maintained low MICs for clinical S. pneumoniae isolates as
    compared to the other antibiotics tested (penicillin G, amoxicillin,
    ceftriaxone, moxifloxacin, levofloxacin, and ceftaroline)
  *The absence of correlation suggests that solithromycin could potentially
    be a useful alternative to these other antibiotics when high levels of
    resistance preclude their use

Abstract E-1187a: 11:00 a.m. CMT, Sept. 12: Solithromycin (CEM-101) In vitro
Susceptibility of Bordetella pertussis, an Emerging Respiratory Pathogen in
the Adult

D. J. Hardy, D. Vicino and P. Fernandes

  *Because of the increasing incidence of B. pertussis (a proposed QIDP)
    infections, and the existence of other respiratory pathogens that cause
    similar clinical symptoms, there is a need for antibiotic coverage of the
    pathogen that provides adequate coverage for a broad range of potential
  *MICs for solithromycin, which is less than or equal to 0.03, were lower
    than comparator antibiotics including amoxicillin/clavulanate, cefdinir,
    cefpodoxime, azithromycin, and clarithromycin in twenty-four clinical
    strains of B. pertussis
  *Solithromycin, which has shown broad coverage against other respiratory
    pathogens, may also be effective against B. pertussis

Abstract E-144b: 12:00 p.m. CMT, Sept. 10:In vitro Activity of Solithromycin
against Macrolide-resistant Streptococcus agalactiae (Group B Streptococcus)

G. Piccinelli, P. Fernandes, C. Bonfanti, M. A. De Francesco

  *S. agalactiae, a proposed QIDP, is the leading cause of morbidity and
    mortality in U.S. infants, and is increasingly resistant to penicillin and
  *In vitro activity of solithromycin was determined against 60
    macrolide-resistant and 10 macrolide-susceptible strains
  *Solithromycin's MICs were lower or similar to those of penicillin, the
    current first-line treatment for S. agalactiae, and showed good activity
    against macrolide-resistant strains suggesting a possible role for
    solithromycin in treating Group B Streptococcus infections

Abstract E-144a: 12:00 p.m. CMT, Sept. 10: Potent In Vitro Activity of
Solithromycin (CEM-101) Against Vancomycin- Resistant and -Susceptible

D.J.Hardy, D.Vicino and P.Fernandes

  *Hospital-acquired strains of enterococci, a QIDP, are often resistant to
    ampicillin, vancomycin and aminoglycosides, and resistance is emerging to
    linezolid, which is approved for treatment of these strains
  *Eighty-eight strains of E. faecium and E. faecalis were tested and
    categorized as either vancomycin-sensitive or -resistant and their
    susceptibility to solithromycin and other antibiotics were assessed
  *Solithromycin's MICs were lower than those of penicillin, vancomycin,
    ceftaroline, azithromycin, gentamicin, linezolid and daptomycin suggesting
    that solithromycin should be explored as a potential treatment for
    enterococcal infections

Abstract C1-1578: 8:30 a.m. CMT, Sept. 13: Molecular Mechanisms of
Solithromycin Resistance in Mycoplasma genitalium

J. S. Jensen, P. Fernandes, M. Unemo

  *Data from recent trials have shown that the cure rate of Mycoplasma
    genitalium after treatment with azithromycin has dropped from 90% to 40%
  *40 strains were assessed, including 15 macrolide-resistant strains,
    against solithromycin and several macrolides and fluoroquinolones and the
    genetic basis for resistance to solithromycin was characterized in the few
    solithromycin-resistant strains
  *In vitro activity of solithromycin was superior to that of azithromycin,
    erythromycin, ciprofloxacin, moxifloxacin and doxycycline; the few
    strains resistant to solithromycin, as shown by higher MICs, were found to
    have mutations in position 2058 of a 23S rRNA gene, but not in other
    positions tested

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
of studies of our product candidates conducted by others; the results, timing,
costs and regulatory review 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
         Andreas Marathovouniotis
         Russo Partners LLC
         (212) 845-4235
Press spacebar to pause and continue. Press esc to stop.