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Savara Pharmaceuticals' AeroVanc Granted U.S. Orphan Drug Designation for the Treatment of MRSA Lung Infection in Cystic Fibrosis Patients
Date:11/13/2012

AUSTIN, Texas, Nov. 13, 2012 /PRNewswire/ -- Savara Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug status to AeroVanc™ (vancomycin hydrochloride inhalation powder) for the treatment of pulmonary methicillin-resistant Staphylococcus aureus (MRSA) infection in cystic fibrosis (CF) patients. Orphan drug designation qualifies a company for several benefits, including the potential for market exclusivity, development grants, and for certain tax credits.

AeroVanc is the first inhaled antibiotic being developed to address the growing population of MRSA-infected CF patients. Savara is currently preparing for its Phase IIa clinical study of AeroVanc's efficacy, to be carried out in 20 CF centers in the United States. In Phase I studies of AeroVanc in healthy volunteers and CF patients, AeroVanc was well tolerated and demonstrated an excellent pharmacokinetic profile.

"AeroVanc is a much needed addition to the current treatment options for MRSA infected CF patients," said Michael Konstan, M.D., Chairman, Department of Pediatrics, and Director of the Cystic Fibrosis Center at Rainbow Babies and Children's Hospital and Case Western Reserve University. "In the absence of an FDA approved inhaled antibiotic therapy directed at MRSA, CF clinicians are increasingly prescribing off-label nebulization of the intravenous formulation of vancomycin. This therapy is generally well tolerated, has high antibacterial activity against MRSA, and patients have a good clinical response."

"Orphan drug designation in combination with our intellectual property provides strong market exclusivity potential for AeroVanc," said Robert Neville, Chief Executive Officer of Savara Pharmaceuticals. "We hope to provide similar benefits to MRSA infected patients that tobramycin provides for the treatment of Pseudomonas aeruginosa infections. The response from the cystic fibrosis community has
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