EXOME

all the information, none of the junk | biotech • healthcare • life sciences

No Details Yet, But Amgen Touts Success in Big Heart Drug Study

Xconomy San Francisco — 

Amgen revealed on Thursday that its cholesterol lowering drug, evolocumab (Repatha)—part of a new class of heart treatments called PCSK9 inhibitors—has reduced the risk of heart attacks and strokes in a massive, 27,500 patient trial.

Thousand Oaks, CA-based Amgen (NASDAQ: AMGN) didn’t disclose the actual magnitude of the benefit evolocumab produced in the study, an “outcomes” trial known as FOURIER—just that it met all of its main and secondary goals and that no new safety issues cropped up. Detailed results from the study will be disclosed at the American College of Cardiology’s annual meeting on March 17, and are sure to be heavily scrutinized.

That means there will be a lot of guessing as Amgen prepares to reveal the actual numbers in March. If they’re very positive, the news could be a potentially massive win for Amgen for a few reasons. First, the FOURIER study is the first major proof that PCSK9-blocking drugs—first approved in 2015—don’t just significantly lower low-density lipoprotein (LDL), or “bad” cholesterol, but improve peoples’ health outcomes too. Evolocumab and Regeneron Pharmceuticals (NASDAQ: REGN) and partner Sanofi’s rival alirocumab (Praluent) have struggled mightily to meet their once-lofty sales projections because insurers have put a chokehold on coverage for the pricey drugs, which cost roughly $14,000 a year before discounts and have to be taken every month or two for life. Though some observers have said that the companies will still have to lower their prices significantly anyway for the drugs to become big sellers, good data from the FOURIER study could mean that insurers finally do pay for them. (Regeneron’s rival trial, named ODYSSEY OUTCOMES, is expected to produce data this year as well.)

Second, Amgen last month won a patent infringement suit against Regeneron—a ruling that threatens to pull Regeneron’s drug from the market. Regeneron has since appealed the ruling, and CEO Len Schleifer even railed against Amgen at the J.P. Morgan Healthcare Conference for the company’s tactics, saying, according to a Reuters report, “if they really cared about patients, they wouldn’t rip this drug from patients.” If Amgen prevails in the appeal, however, it could have the only PCSK9 blocker on the market. In a recent research note, RBC Capital Markets’ Michael Yee wrote that with positive FOURIER results and alirocumab off the market, evolocumab’s peak sales could jump from to $3 billion to $4 billion a year. Evolocumab generated $141 million in revenue in 2016.

“These FOURIER results show unequivocally the connection between lowering LDL cholesterol with [evolocumab] and cardiovascular risk reduction, even in a population already treated with optimized statin therapy,” Amgen R&D chief Sean Harper said in a statement.

Without the details, however, it’s impossible to gauge just how big a victory this is for Amgen. As Leerink Partners’ Geoffrey Porges wrote in a note to investors, Amgen’s announcement “eliminates the very low probability negative result scenario…but confirms nothing about the significance of the event among the wide range of positive scenarios.”

Still, shares of Amgen climbed about 2.5 percent in after-hours trading Thursday.

Here’s more on PCSK9 blockers, and the case their developers have been trying to make to payers.