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Lyon, France - January 11, 2010
Sanofi Pasteur Partners with KaloBios on Novel Biologic for the Prevention and Treatment of Pseudomonas aeruginosa Infections
The Antibody Fragment Could Prevent and Treat Pneumonia
in High-Risk Patients.
Sanofi Pasteur, the vaccines division of the sanofi-aventis Group
(EURONEXT : SAN and NYSE : SNY), announced today an agreement with KaloBios
Pharmaceuticals, a U.S.-based, privately held biotech company, for the development of a
Humaneered™ antibody fragment to both treat and prevent Pseudomonas aeruginosa (Pa)
infections. Most serious Pa infections occur in hospitalized and critically or chronically ill patients--
primarily affecting the respiratory system in susceptible individuals--and are a serious clinical problem
due to their resistance to antibiotics.
Under the terms of the agreement, Sanofi Pasteur acquires worldwide rights to KaloBios’ technology
for all disease indications related to Pa infections except cystic fibrosis and bronchiectasis, which
Sanofi Pasteur has the option to obtain at a later date. KaloBios has already completed phase I
clinical trials - one in healthy volunteers and one in cystic fibrosis patients - and a small proof of
concept phase II clinical trial in mechanically ventilated patients.
“KaloBios has shown convincing safety data in phase I studies and a trend toward efficacy in a phase
II study of ventilator-associated pneumonia,” declared Wayne Pisano, President and CEO of Sanofi
Pasteur. “Hospital-acquired Pa infections are associated with very high levels of morbidity, mortality
and costs and treating them represents a significant, unmet medical need. Despite modern antibiotic
therapy, treatment failures, relapses and deaths are common,” said Pisano.
The two primary target indications for the antibody are prevention of Pa associated pneumonia in
mechanically ventilated patients in hospitals as well as prevention of relapses and potential
improvement of treatment outcomes in patients with an ongoing Pa infection. Additional indications -
both prophylactic and therapeutic - can be considered later in the lifecycle of the product.
This is the third announcement from Sanofi Pasteur in the last month on product development for
nosocomial infections. On December 16 the vaccine manufacturer announced an agreement with
Syntiron for the development, manufacture, and commercialization of a vaccine to prevent
Staphylococcus infections, and on December 15 the company announced that its phase II vaccine
trial to prevent Clostridium difficile - one of the most common causes of hospital-acquired infection in
Europe and the United States - has expanded into the United States from the United Kingdom.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops
and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis
is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more
information, visit: www.sanofi-aventis.com.
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of
vaccine in 2008, making it possible to immunize more than 500 million people across the globe. A world
leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against
20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than
a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company
invests more than EUR 1 million in research and development. For more information, please visit:
www.sanofipasteur.com or www.sanofipasteur.us
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and development, future clinical data and analysis, including post marketing,
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potential of such products candidates, the absence of guarantee that the products
candidates if approved will be commercially successful, the future approval
and commercial success of therapeutic alternatives as well as those discussed
or identified in the public filings with the SEC and the AMF made by sanofi-aventis,
including those listed under “Risk Factors” and “Cautionary Statement Regarding
Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for
the year ended December 31, 2008. Other than as required by applicable law,
sanofi-aventis does not undertake any obligation to update or revise any forward-looking
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