Presentations include data on CEM-102 Pharmacokinetics-Pharmacodynamics (PK-PD) and Activity against Contemporary Gram-Positive Strains and CEM-101 Activity against Multidrug-Resistant S. pneumoniae Isolates

CHAPEL HILL, N.C., Oct. 22 /PRNewswire/ -- Cempra Pharmaceuticals today announced its schedule of oral and poster presentations at the Infectious Disease Society of America, 47th Annual Meeting, in Philadelphia on Oct. 29 to Nov. 1, 2009.

Four presentations on CEM-102 will present results on the compound's in vitro activity against gram-positive organisms, featuring resistance frequencies, and the drug's PK-PD profile when a novel dosing regimen is used. A fifth presentation will present in vitro data on CEM-101's activity against multidrug-resistant S. pneumoniae.

CEM-102 is an oral formulation of fusidic acid, an agent with activity against gram-positive organisms including methicillin-resistant S. aureus (MRSA). The compound is Cempra's lead molecule currently in Phase 2/3 clinical trials, vs. linezolid, being investigated for the treatment of acute bacterial skin structure infections (ABSSIs). This novel adaptive trial is expected to flow into a Phase 3 pivotal trial in Q1 2010. CEM-101, Cempra's novel oral fluoroketolide, will soon enter a Phase 2 clinical trial for moderate-to-moderately severe community-acquired bacterial pneumonia (CABP). CEM-101 has shown potent activity against S. pneumoniae, including multidrug-resistant isolates.

Cempra Pharmaceuticals IDSA 2009 Schedule At-A-Glance

Friday, October 30, 2009

    -- Poster presentation: "Contemporary Activity of CEM-102 (Fusidic
       Acid [FA]) Against Canadian Isolates of Staphylococci and Streptococci
       (2001-2006)"
       Time: On display 12:30 to 2 p.m. EDT, Poster Hall A, Poster # 202
       Paul R. Rhomberg, B.S., Leah N. Woosley, B.S., Helio S. Sader, M.D.,
       Ph.D., Ronald N. Jones, M.D., FIDSA
       JMI Lab., North Liberty, IA.
       Presenter: Ronald N. Jones, M.D., FIDSA

    -- Poster Presentation: "Update on the Spectrum of CEM-102 (Fusidic
       Acid [FA]) Against Contemporary Wildtype (WT) Bacterial Species
       Including Mutational Resistance Analysis and Synergy Testing"
       Time: On display 12:30 to 2 p.m. EDT, Poster Hall A, Poster # 203
       Paul R. Rhomberg, B.S., Rodrigo E. Mendes, Ph.D., Holly K. Becker,
       B.S., Kelley A. Fedler, B.S., Helio S. Sader, M.D., Ph.D., Ronald N.
       Jones, M.D., FIDSA
       JMI Lab., North Liberty, IA.
       Presenter: Ronald N. Jones, M.D., FIDSA

    -- Poster presentation: "CEM-101, A Novel Fluoroketolide: Activity Against
       Recent (2008) Isolates of Multidrug-Resistant (MDR) S. pneumoniae
       (SPN)"
       Time: On display 12:30 to 2 p.m. EDT, Poster Hall A, Poster # 208
       Ronald N. Jones, M.D., FIDSA(1), Matthew G. Stilwell, B.S.(1), Helio S.
       Sader, M.D., Ph.D.(1), Prabha Fernandes, Ph.D.(2)
       (1)JMI Lab., North Liberty, IA, (2)Cempra Pharmaceuticals, Chapel Hill,
       NC.
       Presenter: Ronald N. Jones, M.D., FIDSA

    -- Poster presentation: "Performance of CEM-102 (Fusidic Acid [FA])
       Susceptibility Testing Reagents; Broth Microdilution, Disk Diffusion
       and Etest Methods"
       Time: On display 12:30 to 2 p.m. EDT, Poster Hall A, Poster # 261
       Paul R. Rhomberg, B.S., Leah N. Woosley, B.S., Helio S. Sader, M.D.,
       Ph.D., Ronald N. Jones, M.D., FIDSA
       JMI Lab., North Liberty, IA.
       Presenter: Ronald N. Jones, M.D., FIDSA

Saturday, October 31, 2009

    -- Oral Presentation: "CEM-102 (Sodium Fusidate) Dosage Regimen Decision
       Support Using Population Pharmacokinetic (PPK) and Mechanism-Based
       Pharmacokinetic-Pharmacodynamic (PK-PD) Models"
       Time of Presentation: 3:30 to 3:45 p.m. EDT, Room 105-AB
       Olanrewaju O. Okusanya, Pharm.D., BCPS(1), Jurgen B. Bulitta, Ph.D.(1),
       Alan Forrest, Pharm.D.(1,2), Brian T. Tsuji, Pharm.D.(2), Sujata M.
       Bhavnani, Pharm.D, M.S.(1,2), J. Gordon Still, M.D., Ph.D.(3),
       Prabhavathi Fernandes, Ph.D.(3), Paul G. Ambrose, Pharm.D., FIDSA(1,2);
       (1)ICPD/Ordway Res. Inst., Latham, NY, (2)SUNY, Buffalo, NY, (3)Cempra
       Pharmaceuticals, Chapel Hill, NC.
       Presenter: Alan Forrest, Pharm.D.

About Cempra Pharmaceuticals
Founded in 2006, Cempra Pharmaceuticals is a privately-held, clinical-stage biotechnology company focused on developing antibacterials to address critical medical needs. Two lead products, both in late-stage clinical trials, address the urgent and increasing need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra is well-funded and is committed to developing commercially viable products through consideration of pricing and reimbursement issues throughout its products' lifecycles. The company is also utilizing its proprietary chemistry technology to develop macrolides without antibacterial activity for non-antibiotic uses in motilin receptor activity, anti-inflammatory activity and GnRH receptor antagonism. Additional information about Cempra can be found at www.cempra.com.

SOURCE Cempra Pharmaceuticals

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