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| Pfizer CEO Ian Read |
Pfizer ($PFE) has spent the past few years trying to turn its sprawling, expensive R&D operation into an efficient, slimmed down drug development machine. The cost cutting side has gone well. Now it needs to show the R&D team can make money too by delivering a new wave of drugs and vaccines.
Talking to investors following the release of fourth quarter results, Pfizer CEO Ian Read said the company will present data from Phase II trials of its Staphylococcus aureus and meningococcal B vaccines later this year. The S. aureus trial wrapped up last year and Read hinted he is happy with the data, saying there are "encouraging signals" that the vaccine generates a positive immune response. Pfizer expects to present the data at a medical conference this year and advance to late phase trials.
Less than four years ago Merck ($MRK) was talking up the change in antibody levels in patients who received its S. aureus vaccine candidate in a Phase II study. Merck advanced into late-stage trials on the strength of the data, but pulled the plug in 2011 after an interim analysis suggested the vaccine was ineffective. Worse still, it was associated with multiple organ failure and death. Pfizer still faces competition from GlaxoSmithKline ($GSK), Novartis ($NVS) and Sanofi ($SNY) though.
Each is attracted by an untapped market estimated to be worth up to $4 billion. Capturing a decent share of the sector would give Pfizer a product to rival its sole vaccine success, Prevnar 13. Fourth quarter sales of the blockbuster vaccine--and its predecessor Prevnar 7--grew 3% year-on-year, with international markets driving the small uptick. Sales in the U.S. were pretty flat, but Pfizer has a big potential inflection point in its sights.
Data from the CAPiTA trial--which gave Prevnar 13 to people aged 65 and older--is expected this quarter. If positive, Pfizer will take the data to the Advisory Committee on Immunization Practices (ACIP) and request an expansion of the recommended patient population for Prevnar 13. The Wall Street Journal quotes analysts as estimating the recommendation would add $1 billion a year to sales of Prevnar 13, which generated revenue of $4 billion in 2012 and 2013.
- here's the call transcript
- read Pfizer's press release (PDF)
- check out the WSJ article (sub. req.)
- and FierceBiotech's coverage