Pfizer developing cholesterol-fighting vaccine as part of PCSK9 'franchise'

Pfizer R&D chief Mikael Dolsten

SAN FRANCISCO--PCSK9 drugs are the next big market waiting to happen, and with rivals Sanofi ($SNY)/Regeneron ($REGN) and Amgen ($AMGN) ahead in the development race, Pfizer ($PFE) wants to make sure it can lock down a solid share of the market. So beyond in-development anti-cholesterol antibody bococizumab, it's working on a wider PCSK9 "franchise," R&D chief Mikael Dolsten said Tuesday at the JP Morgan Healthcare Conference--and that includes a vaccine.

Dolsten expects the jab--designed to spur the body to produce antibodies for so-called "bad cholesterol" protein PCSK9--to start human trials in 2016, he told Reuters.

"Imagine going to your doctor to get a shot for cholesterol," he told the news service, noting that the vaccine could eventually be an annual injection if it's successful.

In addition to the vaccine, the drug giant is working on a small-molecule PCSK9-inhibiting pill that has already triggered "a substantial reduction" in cholesterol in preclinical animal studies, expected to start human trials later this year, he said. Both those products will back up bococizumab, expected to rake in peak annual sales of almost $2 billion.

"It's a very substantial effort," he told presentation-watchers. "We think this franchise opportunity that we are pushing forward with is an opportunity for us to be a leader and to build a portfolio with complementary positioning for patients and payers in this very large segment of cholesterol management." 

But before Pfizer launches that PCKS9 vaccine testing in humans, it has a "pivotal" Phase IIb study of its Staphylococcus aureus prospect to kick-start--something that will happen in the middle of this year, Dolsten said in the presentation. If the data from that trial prove strong, "we believe there are opportunities to go to dialogues around an accelerated approval" based on the study.

If it does, it wouldn't be the first time for Pfizer's vaccine unit, Dolsten noted: In October, his company snagged a come-from-behind approval for its meningitis B vaccine Trumenba, whose impressive Phase II results helped it beat out Novartis ($NVS) rival Bexsero.

- here's Dolsten's JPM presentation (PDF)
- get more from Reuters
- see FierceBiotech's take

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