260 East Grand Avenue
South San Francisco, CA 94080
KaloBios Partners with Sanofi Pasteur on
Novel Prevention and Treatment for Pseudomonas aeruginosa
-KaloBios' Humaneered™ Antibody Fragment KB001 Blocks Pseudomonas Virulence-
SOUTH SAN FRANCISCO, CA (January 11, 2010) -
KaloBios Pharmaceuticals, Inc. today announced an agreement with Sanofi Pasteur,
the vaccines division of the sanofi-aventis Group, for the development and
commercialization of KB001, an investigational new biologic for the treatment or
prevention of Pseudomonas aeruginosa (Pa) infections. Sanofi Pasteur will be
responsible for the development and commercialization of KB001 and initially
focus on hospital indications, including the prevention of Pa pneumonias in
mechanically ventilated patients. KaloBios will focus on developing and
commercializing KB001 for use in treating patients with cystic fibrosis and
bronchiectasis, an obstructive lung disease aggravated by bacterial infections.
Under the terms of the agreement, KaloBios will receive an upfront payment of
$35 million from Sanofi Pasteur, plus development, regulatory and commercial
milestones for a potential further $255 million, as well as royalties on
eventual product sales. Sanofi Pasteur also has the option to acquire commercial
rights to KaloBios' indications for KB001 outside the United States and
co-promotion rights in the United States.
"Sanofi Pasteur is the world's largest company devoted entirely to human vaccines,
including those for the prevention of pneumonia," said David Pritchard,
President and Chief Executive Officer of KaloBios. "Their enormous development
expertise in the field of infectious disease and worldwide commercialization
capabilities make them the ideal partner for KB001, which has shown early
promise in preventing Pa pneumonia and mortality in mechanically ventilated
patients and in treating patients with cystic fibrosis."
"Hospital-based pneumonias, especially those associated with mechanically
ventilated patients in the ICU, are a life-threatening complication that can
significantly increase mortality and morbidity as well as add tens of thousands
of dollars to the cost of a hospital stay," said Tillman Pearce, M.D., Chief
Medical Officer of KaloBios. "KB001's novel mechanism of action against Pa
provides a unique means of fighting these infections, which are often resistant
to antibiotic therapies. We also think this novel mechanism could have a
significant impact on Pseudomonas aeruginosa infections in cystic fibrosis
patients as well."
About KB001
KB001, a Humaneered™ antibody fragment, is designed to fight
Pseudomonas aeruginosa (Pa) by blocking a virulence mechanism (the Type Three
Secretion System or TTSS) on the bacterium's external surface that enables Pa to
evade human immune defenses by killing white blood cells and epithelial cells,
and triggering tissue-damaging inflammation. By blocking Pa's killing mechanism,
KB001 is intended to reduce the damage done to the lungs by Pa and potentially
enable the patient's own immune system to effectively fight and clear the
bacteria from sites of infection. KB001 avoids known mechanisms of antibiotic
resistance and does not contribute to broad-spectrum resistance, making it
optimal for use as a single agent or in synergy with antibiotics in the
preventive or therapeutic setting. KB001 has completed two Phase 1/2 clinical
studies in mechanically ventilated patients colonized with Pa and in chronically
Pa infected patients with cystic fibrosis.
About KaloBios
KaloBios Pharmaceuticals, Inc., a U.S. based, private monoclonal company, uses
its biologic capabilities and its proprietary platform technology to develop
first-in-class human antibody therapeutics. The company has multiple programs
that have been in seven Phase 1 or 2 clinical trials in the last few years.
KB001 is a PEGylated monoclonal antibody fragment directed against
Pseudomonas aeruginosa that is in development for patients with cystic fibrosis
and patients in intensive care on a ventilator. KaloBios is also developing an
anti-GM-CSF human monoclonal (KB003) for the treatment of patients with
autoimmune and chronic inflammatory conditions, such as rheumatoid arthritis
and asthma. KB004 is a human monoclonal antibody in preclinical development
for hematologic malignancies and solid tumors. The company's Humaneering™
technology is designed to offer advantages over other methods of human antibody
creation in terms of immunogenicity, potency, and manufacturing yields
For more information, visit www.kalobios.com.
Contact:
Media Contact:
David W. Pritchard
President and CEO
KaloBios Pharmaceuticals, Inc.
(650) 243-3100
Joan E. Kureczka
Kureczka/Martin Associates
(415) 821-2413
