Pfizer's C. Difficile Vaccine Gets Fast Track Status


Pfizer Inc. (PFE) announced that its vaccine candidate (PF-06425090) for clostridium difficile infection has been granted fast track designation by the FDA. The designation helps to expedite the development and review process of experimental drugs and vaccines targeting serious diseases.

The company is developing the candidate (currently in phase II) to prevent clostridium difficile-associated disease, which includes life-threatening diarrhea and pseudomembranous colitis.

At present, there are no vaccines available to prevent clostridium difficile-associated disease. As per Centers for Disease Control and Prevention data, it affects approximately 250,000 people each year leading to 14,000 deaths in the U.S. If successfully developed and eventually approved, Pfizer’s candidate has the potential to capture a large part of the market share. However, we note that several other companies are developing a vaccine for the prevention of clostridium difficile infection.

We note that Pfizer possesses one of the world’s leading vaccine operations, with total sales of approximately $2 billion in the first half of 2014. The company’s portfolio includes Prevnar 13, which is indicated for the prevention of various syndromes of pneumococcal disease.

Pfizer carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Amgen Inc. (AMGN), Gilead Sciences Inc. (GILD) and Alexion Pharmaceuticals, Inc. (ALXN). While Amgen and Gilead are Zacks Rank #1 (Strong Buy) stocks, Alexion carries a Zacks Rank #2 (Buy).

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