Cempra to Present Data on Solithromycin's (CEM-101) Potential Against Urogenital Infections and Multidrug-Resistant Pathogens at

    Cempra to Present Data on Solithromycin's (CEM-101) Potential Against
      Urogenital Infections and Multidrug-Resistant Pathogens at ECCMID

- Phase 2 study of patients with gonococcal infections shows 100 percent were
treated successfully

- Solithromycin is active against Mycoplasma genitalium, a pathogen that is
increasingly resistant to treatment with any antibiotic

- Solithromycin demonstrates superior activity to azithromycin against
Legionella pneumophila, a serious pnuemonia pathogen

- Solithromycin demonstrates activity against enterococci, a pathogen with few
treatment options

PR Newswire

CHAPEL HILL, N.C., April 26, 2013

CHAPEL HILL, N.C., April 26, 2013 /PRNewswire/ -- 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 European Congress
of Clinical Microbiology and Infectious Diseases (ECCMID) in Berlin,
demonstrating solithromycin's potential to treat urogenital infections and
combat challenging pathogens such as enterococci and Legionella pneumophila.
All of the presentations will occur on Sunday, April 28.

"Solithromycin, our fourth-generation macrolide, has the right spectrum of
activity against a variety of serious gram positive pathogens as well as an
emerging favorable safety profile," said Prabha Fernandes, Ph.D., chief
executive officer of Cempra. "The studies to be presented at ECCMID
demonstrate the antibiotic's potential against bacterial urethritis as well as
against serious pathogens such as enterococcus and Legionella for which
therapeutic options are either few or decreasing due to increasing antibiotic
resistance. Solithromycin continues to differentiate itself against other
treatments for community-acquired bacterial pneumonia, sexually-transmitted
diseases and other serious infections."

Abstract O 274: 11:42-11:54 a.m. CEST: A phase II study to evaluate the
efficacy and safety of single-dose oral solithromycin (CEM-101) for treatment
of patients with uncomplicated urogenital gonorrhea

E. Hook, III, D. Oldach, B. Jamieson, K. Clark, P. Fernandes

  oPatients with suspected N. gonorrhoeae infections received a single oral
    1,200 mg dose of solithromycin
  oInfections were eradicated from all 22 evaluable patients (from an
    enrollment of 28) including from cervical, urethral, rectal and pharyngeal
    infection sites
  oSolithromycin was well tolerated and was accompanied by only mild
    gastrointestinal effects

Abstract P 1640, 1:30-2:30 p.m. CEST: In vitro and intracellular activity of
solithromycin (CEM-101) against clinical isolates of Legionella pneumophila

J. Mallegol, P. Fernandes, R. Melano, C. Guyard

  oLegionella pneumophila is an important respiratory pathogen
  oAzithromycin and fluoroquinolones are the currently-recommended treatments
    but resistance to both antibiotics is increasing; cephalosporins are
    ineffective
  oSolithromycin demonstrated higher in vitro potency against all L.
    pneumophila isolates than azithromycin

Abstract P 1593, 1:30-2:30 p.m. CEST: Analysis of solithromycin bactericidal
activity against vancomycin-susceptible and vancomycin-resistant enterococci

J Deane, C. Opiela, D Sahm, K. Keedy, A. Sheets, P. Fernandes

  oLinezolid was the last antibiotic approved to treat enterococcal
    infections
  oMICs for solithromycin were relatively low compared to linezolid
    suggesting that a macrolide could be an option to treat these infections
  oAlthough neither solithromycin nor linezolid demonstrated bactericidal
    activity, solithromycin almost eradicated one strain, suggesting that
    solithromycin's spectrum of activity may differ from those of older
    macrolides and ketolides.

Abstract P 1638, 1:30-2:30 p.m. CEST: In vitro activity of solithromycin
(CEM-101) among azithromycin resistant and susceptible Mycoplasma genitalium
strains

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

  oMycoplasma genitalium is a well-known and important cause of sexually
    transmitted infections
  oTreatment with a 1 gram single dose azithromycin induces high-level
    macrolide resistance in many cases where eradication fails; drug-resistant
    strains of M. genitalium are emerging
  oSolithromycin, a new fluoroketolide that is active against other
    urogenital pathogens, demonstrated antimicrobial activity, in vitro, that
    was superior to azithromycin and other macrolides
  oSolithromycin may be a promising alternative to current treatments for M.
    genitalium and its strong activity suggests that the drug could lead to
    less selection of macrolide-resistant strains of M. genitalium

Abstract P 1603, 1:30-2:30 p.m. CEST: Evaluation of disc diffusion testing of
solithromycin using Mueller Hinton fastidious medium

J. Deane, C. Opiela, E. Matuschek, G. Kahlmeter, D. Sahm, K. Keedy, A. Sheets,
P. Fernandes

  oDisk diffusion testing is used in the determination of clinical
    breakpoints to measure pathogen susceptibility to antibiotics
  oThis study determined that solithromycin disk diffusion results obtained
    with the control and clinical strains were comparable with two different
    disk sources on agar from two different manufacturers indicating that
    results are likely to be very similar for the target pathogens, regardless
    of which agar medium (CLSI or EUCAST) is used for testing

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 in advanced clinical development; solithromycin in Phase 3 for
CABP and TAKSTA™ (CEM-102) in Phase 2 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.

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



SOURCE Cempra, Inc.
 
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