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Nabriva Therapeutics' Pleuromutilin Antibiotic BC-3781 Shows Therapeutic Potential for Skin and Lung Infections with both Oral and IV Dosing in Non-Clinical and Clinical Phase I Studies


9/10/2010 11:35:17 AM

Vienna, Austria - September 10, 2010 - Nabriva Therapeutics, a biotechnology company focused on developing a new class of antibiotics for serious infections caused by resistant pathogens, today announced that a series of studies will be presented at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston. The studies show that the Company’s novel pleuromutilin antibiotic BC-3781 can be used orally as well as intravenously for the treatment of skin and lung infections caused by MRSA and other bacteria. BC-3781 exhibits attractive safety, tolerance and pharmacokinetics and is currently in Phase II for acute bacterial skin and skin structure infections (ABSSSI).

Dr. Rodger Novak, Nabriva’s COO, will present an oral summary of the Company’s posters on pleuromutilin BC-3781 at the Session on “Novel antimicrobial agents” on Sunday, September 12th at 1:45 pm. He will be presenting data demonstrating BC-3781’s anti-microbial spectrum and it’s efficacy in non-clinical studies of both skin (ABSSSI) and lung infections, including community-acquired bacterial pneumonia (CABP), as well as data showing the pharmacokinetics of the molecule in clinical Phase I studies when administered intravenously.

Additionally, Nabriva’s CMO, Dr. William Prince will be presenting the latest research results on “Safety, Tolerance and Pharmacokinetics of Single and Repeat Doses of Oral BC-3781, a Novel Antimicrobial”. Study results showed that oral BC-3781 was well tolerated in patients and plasma concentration levels of BC-3781 indicated a therapeutic potential for the treatment of bacterial lung and skin infections. The presentation number is F1-1970 and it will be given on Wednesday, September 15th at 8:30- 8:45 am.

These studies will be presented at the 50th ICAAC in Boston, held on September 12- 15th 2010. The titles and contributors to each poster mentioned above are as follows:

Population Pharmacokinetics of BC-3781 Using Phase 1 Data C. M. Rubino, A. Forrest, S. M. Bhavnani, W. T. Prince, Z. Ivezic-Schoenfeld, W. W. Wicha, P. G. Ambrose

An Age and Gender Study Investigating the Safety, Tolerance and Pharmacokinetics of BC-3781 W. W. Wicha, C. Lell, D. K. Logan, W. T. Prince

Determination of Disk Diffusion and MIC Quality Control Ranges for BC-3781 using CLSI Multi-Laboratory M23-A3 Study Design J. E. Ross, R. N. Jones, H. S. Sader, Z. Ivezic-Schoenfeld

Activity BC-3781, a Novel Pleuromutilin Compound, Tested Against Clinical Isolates of MRSA, Including Molecularly Characterized Community-Acquired and Hospital-Associated Strains H. S. Sader, D. J. Biedenbach, Z. Ivezic Schoenfeld, S. Paukner, R. Novak, R. N. Jones

Antimicrobial Activity of The Investigational Pleuromutilin BC-3781 Against Organisms Responsible for Community-acquired Respiratory Tract Infections (CA-RTI) H. S. Sader, S. Paukner, Z. Ivezic Schoenfeld, F. J. Schmitz, D. J. Biedenbach, R. N. Jones

Efficacy of BC-3781 in Murine Pneumonia Models W. W. Wicha, Z. Ivezic Schoenfeld, R. Novak

In Vivo Pharmacodynamic Activity of BC-3781 W. A. Craig, D. Andes, Z. Ivezic Schoenfeld, R. Novak, W. W. Wicha

Pre-clinical Efficacy of BC-3781 in Thigh and Bacteremia Infections Caused by Staphylococci W. W. Wicha, Z. Ivezic Schoenfeld, R. Novak

About Nabriva Therapeutics

Nabriva Therapeutics is a biotechnology company focused on developing a new class of antibiotics for the treatment of serious infections caused by resistant pathogens. Nabriva’s lead systemic product, BC-3781, is being developed for the treatment of serious skin infections and bacterial pneumonia caused by S. aureus, , S. pneumoniae, H. influenza, Mycoplasma, Legionella and other bacteria, including drug resistant strains such as MRSA and vancomycin resistant E. faecium. In addition, Nabriva Therapeutics’ topical pleuromutilin product candidate, BC-7013, is in clinical phase I. Nabriva Therapeutics has a proven track record in world-class medicinal chemistry, clinical expertise, a seasoned management team and solid IP. Nabriva Therapeutics is located in Vienna, Austria.

For more information on Nabriva please visit www.nabriva.com.

Contact: Nabriva Therapeutics AG College Hill Life Sciences Dr David Chiswell CEO T +43 (0)1 740 93-0 OFFICE@NABRIVA.COM Dr Douglas Pretsell Senior Account Director T +49 (0)89 57001806 douglas.pretsell@collegehill.com



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