Good afternoon, readers.
Shares of Ireland-based biopharma Amarin Corporation spiked more than 20% in Thursday trading—a jump that adds to the “fish oil pill” company’s bullish run since the beginning of the JPMorgan Healthcare conference on Monday. Amarin stock is up 45% in the past five days.
Two separate, and related, factors are likely driving the trend: Impressive presentations by Amarin CEO John Thero during investor presentations at the JPM conference (I interviewed Thero on Monday evening, and he projected the sort of product confidence that often proves catnip to the shareholder crowd); and water cooler gossip on Thursday that a pharma giant like Pfizer may be interested in snapping up the approximately $6 billion market cap company.
As we’ve previously reported, Amarin made waves—and elicited controversy—this past November when it released eye-popping heart benefit results for its prescription strength fish oil drug Vascepa. According to results of the REDUCE-IT study published in the New England Journal of Medicine, Vascepa use slashed the risk of deadly cardiovascular events like stroke and heart attack for certain patients by 25% on top of cholesterol-checking medications like statins.
Some critics noted concerns with Amarin’s study design and questioned the nature of the placebo used in the trial. Here’s what Thero had to say about that: “Any time you have a profound effect like this, it’s going to be critically approached. And that’s a good thing. But we believe the experts who reviewed this study are satisfied and agree the results are significant.”
That argument—as well as Thero’s point that non-prescription, over-the-counter fish oil supplements (so-called Omega-3 mixtures) have received an increasing amount of scrutiny over efficacy—seems to have swayed investors in recent days.
So what’s next for Amarin? “The first step here is, we really do need to get the Vascepa drug label expanded to include the cardiovascular risk reduction, and then educate the physicians on those effects; after that, we will work on educating consumers.”
Read on for the day’s news.
Game developers aren’t huge fans of the “gaming disorder” label. Last year, the World Health Organization (WHO) officially proposed naming a new class of mental health disease: “Gaming disorder.” As it turns out, the video game industry isn’t exactly psyched about that. “It’s our hope that through continued dialogue we can help the WHO avoid rushed action and mistakes that could take years to correct,” said Entertainment Software Association (ESA) head Stanley Pierre-Louis in a statement, according to Reuters; the WHO and various gaming groups have reportedly had conversations on the matter, with industry arguing that an official disorder classification would be too hasty without further study. Gaming disorder, under the WHO’s proposal, would be defined by an addiction to gaming that stunts someone’s personal or professional life. (Reuters)
Congressional Democrats unveil major drug pricing bills. Congressional Democrats in the U.S. House and Senate on Thursday unveiled a trio of legislation meant to keep drug prices in check. The bills were released by Sen. Bernie Sanders and various Democrats in the Senate and Rep. Elijah Cummings in the House; their provisions include allowing importation of cheaper drugs from abroad, direct Medicare negotiation over drug prices, and increased authority for the federal government to counteract drug makers’ carte blanche monopoly power. Unsurprisingly, such proposals are strongly opposed by drug makers. President Donald Trump, however, has recently re-upped his criticism of high drug prices in the wake of a slew of new year price hikes. Then again, HHS Secretary Alex Azar has homed in on lowering list prices, which don’t necessarily reflect what’s payed on net by patients.
European price watchdog keeps up the heat on Novartis. EU drug regulators continue to put the squeeze on drug giant Novartis. On Thursday, the European National Institute for Health and Care Excellence (NICE) issued draft guidance stating that Novartis’ potential blockbuster migraine prevention drug Aimovig is too pricey compared to its benefit. NICE has also pushed back on recommending Novartis’ pioneering (but expensive) cancer CAR-T treatment Kymriah for certain adult patients. (FiercePharma)
THE BIG PICTURE
Have private insurance? You’re out of luck at this major San Francisco ER. Vox’s Sarah Kliff has an absolute must-read report on Zuckerberg San Francisco General Hospital, the city’s largest public hospital, and its highly unusual billing practices. How unusual? The hospital’s emergency room department is out of network for all private insurance—including for the hospital’s own employees’ private health plans—often leaving patients taken to the ER with insanely high out-of-pocket bills, according to Kliff. The hospital claims it’s a justified practice to subsidize people with public health plans; multiple health economists took exception to that claim. (Vox)
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|Produced by Sy Mukherjee|