Pfizer’s Investigational Vaccine Candidate for Clostridium difficile Receives U.S. Food and Drug Administration Fast Track Designation

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August 28, 2014

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). Currently in Phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile-associated diseasewhich can include life-threatening diarrhea and pseudomembranous colitis.

“C. difficile is a growing, difficult-to-treat healthcare-associated infection,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer. “No vaccine is currently available to prevent the infection-associated disease. In the United States alone, there are approximately 250,000 cases of C. difficile-associated disease, resulting in approximately 14,000 deaths each year.1”

The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.2

About Clostridium difficile

Clostridium difficile (klos-TRID-e-um dif-uh-SEEL), often called C. difficile, is the most frequent cause of healthcare-associated infections.3 C. difficile is a spore-forming, Gram-positive anaerobic bacillus that produces two exotoxins: toxin A and toxin B. It is a common cause of antibiotic-associated diarrhea (AAD) and accounts for 15-25 percent of all episodes of AAD.4

Illness from C. difficile most commonly affects older adults in hospitals or in long-term care facilities and typically occurs after use of antibiotic medications. However, studies show increasing rates of C. difficile infection among people traditionally not considered high risk, such as younger and healthy individuals without a history of antibiotic use or exposure to healthcare facilities.5

Infection with C. difficile places a significant burden on healthcare facilities6,7 and has been shown to substantially increase hospital costs, hospital length of stay, and contribute to mortality.

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.

1. Centers for Disease Control and Prevention. Investigating Clostridium difficile Infections Across the U.S. Available athttp://www.cdc.gov/features/AntibioticResistanceThreats/index.html

2. U.S. Food and Drug Administration,http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#fasttrack

3. The New England Journal of Medicine; March 27,2014. Multi-State Point Prevalence Survey of Health Care-Associated Infections. NEJM.org.

4. Centers for Disease Control and Prevention. Frequently Asked Questions. Available at http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_faqs_HCP.html

5. The Mayo Clinic. Diseases and Conditions. Available at http://www.mayoclinic.org/diseases-conditions/c-difficile/basics/definition/con-20029664

6. Dubberke ER, Butler AM, Reske KA, AgnielD, Olsen MA, D’Angelo G, McDonald LC, Fraser VJ: Attributable outcomes of endemic Clostridium difficile-associated disease in nonsurgical patients, Emerg Infect Dis 2008, 14:1031-1038.

7. Dubberke ER, Butler AM, Reske KA, AgnielD, Olsen MA, D’Angelo G, McDonald LC, Fraser VJ: Short- and long-term attributable costs of Clostridium difficile-associated disease in nonsurgical patients. Clin Infect Dis 2008, 46:497-504

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