Pfizer's bococizumab may hit the PCSK9 market just in time

Pfizer tallied a couple more wins in its lineup of late-stage PCSK9 trials: Bococizumab, a would-be competitor to similar meds from Amgen, Sanofi and Regeneron, beat placebo at pulling down cholesterol levels in two different types of patients.

The new data add to Pfizer’s case for bococizumab approval. But company executives know its late-to-the-party entrant will need more than that to steal share from Amgen’s Repatha and Sanofi and Regeneron’s Praluent.

Pfizer has planned all along to bring bococizumab to market along with cardiovascular outcomes data--data it hopes will show that the drug not only lowers LDL cholesterol dramatically, but also helps prevent CV problems such as heart attacks and strokes. By Pfizer’s rough estimate, given that it’s a CV events-driven trial, we could see those results during the second half of next year.

With any luck, those outcomes data will arrive close on the heels of an FDA approval for bococizumab, giving Pfizer plenty of ammo in its battle against Repatha and Praluent. And with outcomes data still forthcoming for those two drugs--Amgen, in the lead on that front, expects its numbers at the end of this year--Pfizer could find itself not so far behind.

Thing is, Repatha and Praluent are struggling to gain traction in the real world, despite their proven ability to lower cholesterol in patients who’ve had no success with statins, even at their highest doses. At a list price of more than $14,000 a year, the two meds are expensive, and without outcomes-trial data bolstering their case, doctors and payers have been slow to sign on.

Significant reductions in heart risks would turn the tide, doctors say, which is why people are watching Amgen’s trial so closely. If Repatha scores, that’s great for Amgen--but it might not benefit Repatha alone. CV benefits might be assumed as a classwide effect, lifting the other PCSK9s along with it.

So, the PCSK9 market may just be gathering steam when and if Pfizer’s drug launches.

That would be a vindication for Pfizer CEO Ian Read, who’s banking on bococizumab to help pitch in new sales. Read has said that the PCSK9s should not be launched at all without outcomes data.

“We've always said that on LDL alone, it will be difficult to convince society to pay what's necessary,” Read said during Pfizer’s first-quarter earnings call. “What moves the needle is the large prospective trials which show that outcomes are changed. ... So I look forward to that class expanding when we have the outcomes data and we have the right value equation for society.”

Pfizer is confident enough in that value equation that it’s developing a wider PCSK9 franchise. Beyond bococizumab, which is an antibody drug, it’s working on a small-molecule PCSK9 inhibitor that has already triggered "a substantial reduction" in cholesterol in preclinical animal studies; that drug was expected to start human trials this year. It’s also working on a related vaccine candidate.

"It's a very substantial effort," R&D chief Mikael Dolsten said in January at the big J.P. Morgan Healthcare Conference. "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."

- see Pfizer’s Q1 transcript
- get the company’s bococizumab release

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