Cempra Pharmaceuticals Will Present New Data on CEM-101 and TAKSTA(TM) (CEM-102) at the 20th European Congress of Clinical Microbiology and Infectious Disease

CHAPEL HILL, N.C., April 8 /PRNewswire/ -- Cempra Pharmaceuticals today announced its schedule of poster presentations at the 20th European Congress of Clinical Microbiology and Infectious Disease (ECCMID) in Vienna, Austria, on April 10-13, 2010.

One poster will present Phase 1 multi-dose clinical results for CEM-101, a next-generation oral and intravenous macrolide.  Four additional presentations on CEM-101 will present results on the compound's in vitro activity against a variety of bacterial pathogens, including drug-resistant strains.  A sixth poster will present in vitro activity of TAKSTA (CEM-102) against European gram positive isolates, including staphylococci, streptococci and enterococci.  TAKSTA (sodium fusidate) is a highly active antibiotic against methicillin-resistant Staphylococcus aureus (MRSA).  It is in development in the U.S. for acute bacterial skin structure infections (aBSSI) employing a proprietary front-loading oral dosing regimen.  All six posters will be presented during the poster session scheduled for 12:30 to 1:30 p.m. CET on Sunday, April 11.

Cempra Pharmaceuticals ECCMID 2010 Schedule At-A-Glance

Sunday, April 11, 2010

• Poster presentation: "CEM-101, a novel fluoroketolide, tested against European clinical isolates from 2009 (first-year surveillance results)"

Time: On display 12:30 to 13:30 p.m. CET, Poster # 901

R. Jones, D. Farrell, H. Sader, M. Stilwell, M. Castaheira (JMI Laboratories, North Liberty, IA, USA)

• Poster Presentation: "Multiple dose pharmacokinetics and safety of CEM-101, a new fluoroketolide, in healthy subjects"

Time: On display 12:30 to 13:30 p.m. CET, Poster # 902

J.G. Still, K. Clark, T. Degenhardt, D. Scott, P. Fernandes (Cempra Pharmaceuticals, Chapel Hill, USA)

• Poster Presentation: "CEM-101, a novel ketolide; in vitro activity against Legionella pneumophila"

Time: On display 12:30 to 13:30 p.m. CET, Poster # 903

J. Dubois(1), P. Fernandes(2) ((1)M360, Sherbrooke, Canada, (2)Cempra Pharmaceuticals Inc., Chapel Hill, USA)

• Poster Presentation: "CEM-101, a novel ketolide, in vitro activity against resistant strains of Streptococcus pnuemoniae and Haemophilus influenza"

Time: On display 12:30 to 13:30 p.m. CET, Poster # 904

J. Dubois(1), P. Fernandes(2) ((1)M360, Sherbrooke, Canada, (2)Cempra Pharmaceuticals Inc., Chapel Hill, USA)

• Poster Presentation: "Expanded studies of CEM-101, a novel fluoroketolide, tested against invasive isolates of N. meningitidis, including flouroquinolone-non-susceptible resistant strains"

Time: On display 12:30 to 13:30 p.m. CET, Poster # 905

R. Jones, D. Biedenbach, L. Woosley, G. Gerken, M. Castaheira (JMI Laboratories, North Liberty, IA, USA)

• Poster Presentation: "CEM-102 (fusidic acid) in vitro activity and evaluation of molecular resistance mechanisms among European Gram-positive isolates, 2008-2009"

Time: On display 12:30 to 13:30 p.m. CET, Poster # 906

M. Castanheira, D. Farrell, M. Janechek, R. Jones

(JMI Laboratories, North Liberty, IA, USA)

About CEM-101

CEM-101 is a next generation macrolide with a number of attributes that may provide clinically important advantages over several comparator products:

• Potent activity, in vitro and in vivo, against all important pathogens that cause community-acquired bacterial pneumonia, including pneumococci, as well as potent activity against a broad spectrum of other serious pathogens including CA-MRSA, M. avium, malaria, atypical bacteria such as Legionella, Mycoplasma, Chlamydophila, and Neisseria
• CEM-101 is generally 8 to 16 times more potent than azithromycin and is active against organisms that have become resistant to azithromycin
• Novel structure with additional binding sites on the bacterial ribosome that confers activity against erm- and mef-resistant strains
• Good tolerability and oral bioavailability in phase 1 trials
• Low resistance frequency in vitro
• Excellent tissue distribution and intracellular tissue concentrations
• Oral and IV formulations
• Once-daily dosing
• Potential for indications beyond CABP, including urethritis and other urogenital infections, bioterrorism targets, malaria, M. avium infections and tuberculosis

The annual incidence for pneumonia in the United States is over 5 million patients each year.  There is a growing need for new drugs to address the issues of drug resistance, tolerability, and administration associated with currently available treatments.  Cempra has licensed exclusive worldwide rights from Optimer Pharmaceuticals, Inc., except in the Association of Southeast Asian Nations (ASEAN) countries, to discover, develop and commercialize macrolides from a library of more than 500 compounds from Optimer's OPopS drug discovery platform.

About TAKSTA™

TAKSTA, (sodium fusidate) is a novel class of antibiotic with an established history of safety and efficacy outside the United States. TAKSTA is being developed as an NCE in the U.S. for aBSSI.  Clinical trials with TAKSTA employ a proprietary front-loading oral regimen designed to increase potency, increase coverage and minimize resistance development.  Cempra believes that TAKSTA will be an important addition to anti-MRSA therapies based on the following:

• Sodium fusidate is orally active against gram-positive bacteria, including all S. aureus strains such as HA-MRSA and CA-MRSA
• TAKSTA employs a novel and proprietary PK-PD-based dosing regimen of sodium fusidate  that optimizes efficacy and minimizes the risk of resistance development
• Sodium fusidate is the only compound within the fusidane class and therefore is unlikely to select for cross-resistance to other classes of antibiotics
• Sodium fusidate's safety has been well documented even when used for long periods of time (over one year) to treat osteomyelitis and other serious infections
• Sodium fusidate has been used safely in children including neonates in countries where it is marketed

About 60 to 80 percent of the 13 million acute skin structure infections that occur in the U.S. each year are infected with MRSA.  There is a growing need for an oral anti-MRSA drug that is safe, effective and is capable of long-term administration.  

About Cempra Pharmaceuticals

Founded in 2006, Cempra Pharmaceuticals is a privately-held, clinical-stage pharmaceutical 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 and medically differentiated and novel products that reduce development risk and provide a high financial return. The company is also utilizing its proprietary compound library and chemistry technology to develop novel macrolides without antibacterial activity for non-antibiotic uses such as COPD, chronic inflammatory and GI disorders. Additional information about Cempra can be found at www.cempra.com.

SOURCE Cempra Pharmaceuticals

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