Interim Capita hit could give Pfizer another $1bn

The US label for the world’s biggest-selling vaccine states: “There have been no controlled trials in adults demonstrating a decrease in invasive pneumococcal disease or pneumococcal pneumonia after vaccination with Prevnar 13.” There have now. The enormous Capita trial has demonstrated exactly that, Pfizer says, and the forthcoming sales boost is expected to add $1bn to the company’s sales.

Pfizer has only released topline data so far, so the vaccine’s true sales potential will not become clear until full results, including its effect on mortality, emerge in a couple of weeks’ time. But the product is on course for a label change and, along with it, a surge in its use.

A feather in its CAP

Prevnar 13 was approved by the FDA for use in adults in 2011 based on serologic immune responses, with the agency tasking Pfizer with a large double-blind confirmatory trial – Capita enrolled 85,000 patients – as a consequence.

The vaccine caused a reduction in the number of first episodes of vaccine-type community-acquired pneumonia (CAP), defined as that caused by any of the 13 S pneumoniae serotypes included in the vaccine, compared with placebo, thereby meeting Capita’s primary endpoint.

Both secondary objectives were also met, with Prevnar 13 proven to decrease the number of first episodes of non-bacteraemic/non-invasive vaccine-type CAP – where a vaccine strain caused pneumonia but was not detected concurrently in the bloodstream or any other normally sterile site – and of vaccine-type invasive pneumococcal disease – in which a vaccine strain was present in the bloodstream with or without pneumonia.

While it is too early to call the trial an unequivocal success, this first evidence of clinical activity bodes well for Pfizer’s efforts to get the Centers for Disease Control and Prevention to recommend wider use of Prevnar 13. The CDC currently recommends its use in high-risk adult patients, principally those with compromised immune systems, as well as all children under five years old.

Such a recommendation would also read across to Europe, where Prevnar 13 is only approved, under the name Prevenar 13, for invasive disease rather than CAP in adults.

Pfizer vs Merck

If the full data – scheduled for release at the International Symposium on Pneumococci and Pneumococcal Diseases in Hyderabad on March 12 – back expanded use, the vaccine’s worldwide sales, currently hovering around $4bn, could jump. Bernstein analyst Tim Anderson wrote that uptake of Prevnar 13 in adults was minimal at present, but sales in the adult population could reach $1.3bn by 2020. These could rise further if a booster regimen is adopted.

Mark Schoenebaum, an analyst at ISI Group, suggests that Prevnar 13’s data are strong enough to allow it to take share from its only competitor in the adult setting, Merck & Co’s Pneumovax. Prevnar 13 sells for around $120 per dose, twice the price of its rival, which does around $650m of business each year. This means, Mr Schoenebaum contends, that adult sales of Pfizer’s product could top $1.5bn, and even more if the overall incidence of CAP rises.

However, Merck has a new pneumococcal vaccine, V114, in phase II trials, and this could change the landscape again if it gains approval in 2017.

US sales of Prevnar 13 actually declined between 2011 and 2013, which Pfizer blamed on the timing of government purchases. If the full data show a mortality benefit, if the CDC gives the vaccine the thumbs-up, and if Europe and other markets follow the US’s lead, sales will increase markedly.

Study Trial ID
Capita NCT00744263

To contact the writer of this story email Elizabeth Cairns in London at [email protected] or follow @LizEPVantage on Twitter

Share This Article