Who's worried about the drug-pricing debate? Regeneron's CEO, for one

Regeneron CEO Leonard Schleifer

Are C-level execs really listening to the brouhaha over drug prices? With new drugs still rolling out in the U.S. at big premiums, one might think not. But if Regeneron ($REGN) chief Leonard Schleifer is speaking for his colleagues, then the answer is yes.

In an interview with The Wall Street Journal, Schleifer admitted that he's concerned about the debate around high drug prices--and how it might affect his company.

"I am worried about it," Schleifer told the Journal. "At the end of the day, if we can't justify the prices that we put out for our products, show that they create value for patients individually and the healthcare system as a whole, then we're not going to be able to get good prices [from insurers], and good prices are essential."

Schleifer knows something about cost comparisons. Regeneron's current fortunes are built on Eylea, a treatment for vision-robbing conditions such as wet age-related macular degeneration. It hit the market a few years after Roche ($RHHBY) and Genentech rolled out Lucentis, an eye-specific variant of their cancer drug Avastin.

While opthalmologists and payers debated about subbing Avastin off-label for the much pricier but FDA-approved Lucentis, Eylea stepped into the U.S. market with a slightly lower price and a less-frequent injection schedule. Thus the Regeneron drug made itself a comparative bargain against Lucentis.

Regeneron's development partner on Eylea, Bayer, has had to offer discounts to win over payers in other countries. In the U.K., cost-effectiveness watchdogs rejected the drug at first, but changed its mind after Bayer extended a cost-cutting offer.

But Schleifer may be most worried about a cholesterol drug Regeneron is developing with Sanofi ($SNY), alirocumab. A PCSK9 inhibitor, it's one of a new class of cholesterol fighters nearing FDA approval. The PCSK9 meds are expected to be expensive, and with most of the previous generation of cholesterol meds--statins--now off patent, persuading payers could be a chore. Pfizer ($PFE), for one, has said it designed Phase III trials not only for its PCSK9 drug's FDA approval, but to prove to payers that it's worth the money.

For now, Schleifer says, the company is prepping for launch, but focused more tightly on getting the drug submitted for FDA approval, which it expects to do before year's end. "We're working our tails off," he told the WSJ. "We think we have a great potential product. While we're preparing [for the competition], we don't want to get too far ahead of ourselves."

- see the WSJ piece (sub. req.)

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