Epidemiological Study on Ventilator-Associated Pneumonia Incidence Reported at Critical Care Congress, Announces KaloBios

SOUTH SAN FRANCISCO, Calif., Jan. 13, 2014 /PRNewswire/ -- KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) today announced the presentation of epidemiological research sponsored by Sanofi Pasteur, KaloBios' exclusive licensee for KB001-A, estimating the incidence of Pseudomonas aeruginosa Ventilator Associated Pneumonia (Pa-VAP) in at-risk patients requiring intubation and mechanical ventilation. The presentation also describes the risk factors among patients with VAP and Pa-VAP. The new research found similar risk factors and infection rates for VAP across multiple global regions. Moreover, the study results suggest that mechanically ventilated patients who are colonized with Pa are at increased risk of developing Pa-VAP. Sanofi Pasteur is developing KB001-A, KaloBios' anti-PcrV monoclonal antibody (mAb) fragment against Pa for the prevention of Pa‑VAP, in the intensive-care setting.

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The researchers conducted the study in more than 1,800 patients in over 50 intensive care units (ICUs) in the United States, Europe, Latin America and Asia-Pacific. The study found 15.6% of patients in the study across all regions were diagnosed with VAP, with 4.1% diagnosed with Pa-VAP. The researchers also determined the proportion of patients with prior respiratory tract Pa colonization during the study period, among those patients who had surveillance cultures obtained.

"We found that the risk factors and rates of VAP were similar across the regions studied and that patients who were found to be colonized with Pa after requiring more than 48 hours' intubation and mechanical ventilation were at increased risk of developing Pa-VAP," said Dr. Kollef. "The frequency of Pa-VAP was higher in patients who had preceding Pa-positive surveillance cultures: 18% subsequently developed Pa-VAP compared with 4.1% in all patients enrolled in the study."

"These data confirm the importance of Pa as a significant cause of VAP, a condition that can significantly add to the length and cost of hospitalization as well as contribute to increased patient morbidity and mortality," said Nestor A. Molfino, MD, MSc., KaloBios' Chief Medical Officer.

About KaloBios

KaloBios Pharmaceuticals, Inc. is developing a portfolio of proprietary, patient-targeted, first-in-class monoclonal antibodies designed to treat severe life-threatening or debilitating diseases for which there is an unmet medical need, with a clinical focus on severe respiratory diseases and cancer.

Currently, KaloBios has three drug development programs:

• KB003, an anti-GM-CSF mAb with potential to treat inflammatory diseases, being developed for the treatment of severe asthma. Enrollment of 160 patients has been completed in a Phase 2 study in the United States, Europe and Australia.
  
• KB001-A, an anti-PcrV mAb fragment, partnered exclusively with Sanofi Pasteur and is being developed for the prevention and treatment of Pseudomonas aeruginosa (Pa) infection. KaloBios has retained rights for the cystic fibrosis (CF) indication and is conducting a 180 patient Phase 2 study in CF subjects with chronic Pa lung infection in the United States. KaloBios has received Orphan Drug designation from both the U.S. FDA and the European Medicines Agency for KB001-A for the treatment of Pa lung infection in CF patients. Sanofi is pursuing a ventilator-associated pneumonia prevention indication in the intensive care setting, an indication which has received U.S. FDA Fast Track Designation.
  
• KB004, an anti-EphA3 mAb, has potential in treating hematologic malignancies and solid tumors. KaloBios is currently testing this drug in a Phase 1 study in subjects with hematologic malignancies.
  

All of the company's antibodies were generated using its proprietary Humaneered^® technology, a method that converts nonhuman antibodies (typically mouse) into recombinant antibodies that have a high binding affinity to their target and are designed for chronic therapeutic use. The company believes that antibodies produced using its Humaneered^® technology offer important clinical and economic advantages over antibodies generated by other methods in terms of high binding affinity, high manufacturing yields, and minimal to no immunogenicity (inappropriate immune response) upon repeat administration in humans.

For more information on KaloBios Pharmaceuticals, please visit our web site at http://www.kalobios.com.

Forward Looking Statements
This release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and statements regarding the company's clinical development of KB001-A, KB003 and KB004. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the company's limited cash reserves and its ability to obtain additional capital on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that the company has initiated or plans to initiate; the company's dependence on Sanofi Pasteur for the development and commercialization of KB001-A; the company's ability to successfully complete further development of its programs; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; the company's ability to protect the company's intellectual property; competition; changes in the regulatory landscape or the imposition of regulations that affect the company's products; and other factors listed under "Risk Factors" in the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 1, 2013, the quarterly reports on Form 10-Q filed on May 14, August 19, and November 12, 2013, and the company's other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The company has no obligation, and expressly disclaims any obligation to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, visit http://www.kalobios.com.

Contact:

Herb Cross
Chief Financial Officer
KaloBios Pharmaceuticals, Inc.
(650) 243-3114
[email protected]

Media Contact:

Joan E. Kureczka
Kureczka/Martin Associates
Tel:  (415) 821-2413
Mobile:  (415) 690-0210
[email protected]

SOURCE KaloBios Pharmaceuticals, Inc.