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KaloBios Provides Update on KB001-A Partnership and Clinical Status
Date:7/28/2014

euticals, or cystic fibrosis who can accelerate and financially support the pivotal studies for KB001-A. "

Sanofi Pasteur agreed to terminate the collaboration and licensing agreement with KaloBios in consideration of low single digit royalties on net sales of KB001-A, subject to a $40 million cap on the aggregate royalties to be paid. In addition, Sanofi Pasteur will be entitled to receive up to 10% of certain sub-license payments or other milestone payments received in the event KaloBios successfully re-partners KB001-A, subject to a separate $40 million cap on the aggregate amount of sub-license payments to be shared with Sanofi Pasteur.

KB001-A Phase 2 Study in CF Patients
KaloBios also announced that it has achieved full enrollment in the 180 patient Phase 2 study evaluating KB001-A in CF subjects with chronic Pa lung infection. KaloBios now expects to release top-line data on this study in early first quarter 2015.

"Enrollment increased dramatically in the last few months due to a number of factors, including additional ex-U.S. sites coming on line and enrolling patients, decreased competition from other studies in the cystic fibrosis space, and some seasonal benefit due to patient availability in the summer months," said Nestor A. Molfino, MD, MSc, Chief Medical Officer of KaloBios. "As a result we were able to make up ground and complete enrollment in the KB001-A Phase 2 study in a timeframe that should enable us to release top-line data in early first quarter 2015." 

KB001-A Development Program
KaloBios had previously completed a Phase 1/2 study with KB001 in thirty-five patients colonized with Pa which demonstrated approximately a 50% reduction in VAP in patients treated with KB001.  The study also showed a dose-dependent increase in bacterial event-free survival relative to placebo. The results of this study were published in Critical Care Medicin
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SOURCE KaloBios Pharmaceuticals, Inc.
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