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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 Antibio

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 indications."

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 pathogens
  • 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 ampicillin
  • 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 Enterococci.

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 Robert.flamm@russopartnersllc.com Andreas Marathovouniotis Russo Partners LLC (212) 845-4235 Andreas.marathis@russopartnersllc.comSource:Cempra, Inc.