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

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

Business Wire

NEW YORK -- August 28, 2014

Pfizer Inc. (NYSE:PFE) 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 disease, which 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.
difficileis 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
facilities^6,7  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
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DISCLOSURE NOTICE: The information contained in this release is as of August
28, 2014. Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or future events or

This release contains forward-looking statements about a product candidate,
PF-06425090, including its potential benefits, that involve substantial risks
and uncertainties that could cause actual results to differ materially from
those expressed or implied by such statements. Risks and uncertainties
include, among other things, the uncertainties inherent in research and
development, including the ability to meet anticipated clinical trial
completion dates and regulatory submission dates, as well as the possibility
of unfavorable clinical trial results; whether and when any biologics license
applications (BLA) may be filed for PF-06425090; whether and when the BLA or
any such other applications may be approved by the FDA or other regulatory
authorities, which will depend on the assessment by such regulatory
authorities of the benefit-risk profile suggested by the totality of the
efficacy and safety information submitted; decisions by the FDA and other
regulatory authorities regarding labeling and other matters that could affect
the availability or commercial potential of PF-06425090 and competitive

A further description of risks and uncertainties can be found in Pfizer’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2013 and in
our subsequent reports on Form 10-Q, including in the sections thereof
captioned “Risk Factors” and “Forward-Looking Information That May Affect
Future Results,” as well as in its subsequent reports on Form 8-K, all of
which are filed with the SEC and are available atwww.sec.govand

1. Centers for Disease Control and Prevention. Investigating Clostridium
difficile Infections Across the U.S. Available at

2. U.S. Food and Drug Administration,

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

4. Centers for Disease Control and Prevention. Frequently Asked Questions.
Available at

5. The Mayo Clinic. Diseases and Conditions. Available at

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,

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,


Pfizer Inc.
Sally Beatty, 212-733-6566
Ryan Crowe, 212-733-8160
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