Pfizer brings S. aureus jab to PhIIb as it keeps the gas on vaccines expansion

Pfizer CEO Ian Read

Pfizer CEO Ian Read has long maintained that the company's vaccines unit should expand beyond the superstar pneumococcal disease blocker Prevenar. In addition to several moves last year and into this year, the company continued that work this week with the announcement of a "pivotal" trial for a surgical site infection candidate.

On Tuesday, the company ($PFE) announced the enrollment of the first patient in a Phase IIb study of its investigational Staphylococcus aureus vaccine that'll test the candidate in patients undergoing elective spinal fusion surgery. In January at the JP Morgan Healthcare Conference, Pfizer R&D chief Mikael Dolsten said that if all goes well with the trial the company believes "there are opportunities to go to dialogues around an accelerated approval."

According to Pfizer, surgical site infections are a growing concern, with S. aureus accounting for approximately 20% of all SSIs and an estimated annual treatment cost of $12.3 billion in the U.S.

Pfizer Vaccines president Susan Silbermann

Tuesday's news comes as Pfizer works to expand its vaccine business beyond the world-bestselling Prevenar, which garnered $4.29 billion in 2014 sales and is anticipated to rake in $5.83 billion in 2020. Last month, the company picked up two meningitis vaccines from GlaxoSmithKline for $130 million to market outside the U.S. That buy added to its previous two in 12 months: Last July, Pfizer announced the $635 million purchase of Baxter's marketed vaccines portfolio, and in January the pharma followed up with the purchase of Switzerland's RedVax for an undisclosed sum.

All told, the acquisitions brought Pfizer vaccines against meningitis C and tick-borne encephalitis as well as a preclinical human cytomegalovirus vaccine candidate, RedVax's tech platform, an undisclosed vaccine program and a vaccine manufacturing facility in Orth, Austria. Also in Pfizer's pipeline is a Phase II vaccine candidate for Clostridium difficile.

Pfizer's moves--plus the possibility of more to come--will be necessary for it to compete in a vaccines race anticipated to be increasingly narrow by 2020. The top four companies--Merck ($MRK), GlaxoSmithKline ($GSK), Sanofi ($SNY) and Pfizer, will be within one percentage point of market share of each other, a recent EvaluatePharma report stated. 

Working against Pfizer in the S. aureus arena is GlaxoSmithKline, which picked up an early stage program and other candidates with its purchase of GlycoVaxyn in February.

- here's the release

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