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U.S. FDA Grants Orphan Drug Designation for KaloBios' KB001-A in Treatment of Cystic Fibrosis Patients
Date:10/30/2013

SOUTH SAN FRANCISCO, Calif., Oct. 30, 2013 /PRNewswire/ -- KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) today announced that the U.S. Food & Drug Administration (FDA) has granted the company orphan drug designation for KB001-A, an anti-PcrV monoclonal antibody (mAb) fragment, for the treatment of cystic fibrosis (CF) patients with Pseudomonas aeruginosa (Pa).

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KaloBios is currently enrolling patients in a Phase 2 multiple-dose, randomized, double-blind, placebo-controlled clinical trial with KB001-A in CF patients chronically infected with Pa. This 180-patient study is intended to evaluate the efficacy and safety of repeat doses of KB001-A. The primary endpoint is time-to-need for antibiotics. To learn more about this study, including eligibility criteria, please visit http://clinicaltrials.gov/ct2/show/NCT01695343?term=kb001a&rank=1

"The FDA's designation of KB001-A as an orphan drug is another milestone for KaloBios as we continue the clinical development work required for potential FDA approval," said David W. Pritchard, KaloBios' President and Chief Executive Officer. "We are working hard to complete enrollment of our Phase 2 trial and look forward to evaluating and reporting on the activity of KB001-A in late 2014."

Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the United States. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is
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SOURCE KaloBios Pharmaceuticals, Inc.
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