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Monday, November 7, 2016

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of all the biotech news. Follow us on Twitter: @damiangarde@megkesh, and @statnews

An inflammatory ad campaign on drug pricing

at least they could have used a wrinkle-free mugshot (youtube)

Mud slinging isn't just for candidates. In the closing days of the campaign, the pro-Prop 61 group Californians for Lower Drug Prices has released a series of brutal online ads painting pharma execs as criminals.

"Court records alone show these drug companies have the morals and ethics of junkyard dogs," Garry South, the campaign's chief strategist, said in a release.

Prop 61, of course, is a California ballot proposition that would cap the amount some state health plans could pay for medications. Drug companies have spent about $110 million to try to take it down. But it's anyone's game: A recent poll showed voters evenly split.

The  "Wanted" ads, which will air on TMZ, Facebook, Politico and other online sites, target Allergan's Brent Saunders, Johnson & Johnson's Alex Gorsky, Merck's Kenneth Frasier, Pfizer's Ian Read, AbbVie's Richard Gonzalez, and Amgen's Robert Bradway

The "No" campaign, meanwhile, is touting editorials from top newspapers across the state urging a no vote. And it's making the case that the measure would save money only for select Californians, while forcing drug companies to raise prices for everyone else.

People keep making the FDA talk about Sarepta

Put FDA officials in a public forum and you can guarantee one thing: Someone’s going to bring up the Sarepta saga.

The agency’s September decision to approve a drug for Duchenne muscular dystrophy based on scant evidence strongly divided opinion outside the agency — and, as internal emails reveal, within it as well.

And so naturally Dr. John Jenkins, director of the agency’s Office of New Drugs, got hit with a Sarepta question minutes into a panel discussion on Friday.

“I think it was a case where very reasonable, educated, dedicated people can look at the same data and come to different conclusions,” Jenkins said. What concerns him is not dissent within the agency but the anonymous invective “from tweets and blogs” that has since greeted his staff.

“Unfortunately, the tone in Washington can spill into other areas,” he said. “It’s OK to disagree. You don’t have to be disagreeable to disagree.”

A few hours later, someone asked Jenkins’ boss, FDA Commissioner Dr. Robert Califf, about the toughest call he’s had to make since starting the job this year.

“It may surprise you to hear it’s not the Sarepta decision,” he said. The hardest choices, he explained, are routine — and rather less controversial — decisions about resource allocation.

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An enzymatic approach to cancer

Everyone talks immunotherapy these days when it comes to cancer — but that’s not the only route to creating a compelling cancer drug.

STAT chatted with David Lowe, CEO of Austin-based Aeglea Biotherapeutics, which is engineering enzymes to interfere with cancer metabolism. It’s in a handful of Phase 1 trials with a drug that targets the enzyme arginine, which has been implicated in helping cancer cells grow. 

What do you do?

We're developing engineered human enzymes, and our drugs are designed to deplete or degrade specific amino acids in patients’ blood to target tumor metabolism in cancer treatment. We’re also creating enzyme replacement therapy to treat genetic rare diseases.

Why amino acids?

There’s a lot known about amino acid biology and the disease pathways that we’re targeting across our pipeline of engineered enzymes. However, amino acids have generally been elusive as drug targets — because the human genome hasn’t provided candidates to go after.

Are any healthy cells dependent on arginine? What happens if you starve them, too?

Arginine is what’s called a semi-essential amino acid. In situations of infection or rapid tissue regeneration, then an external supply might be needed — but most of the time, you can get by for prolonged periods of time with very little arginine. We think cancer cells have a harder time surviving without it, though.

Why aren’t too many other companies working on enzyme degradation drugs? 

These are ideas that have been out there a long time.... There’s such a deep literature in using microbial enzymes to degrade arginine.... [We] use human scaffolds instead of microbial enzymes. That’s really the beauty of science, because what seems obvious in hindsight isn’t the case in the beginning.

What's happening at Alexion?

Biotech investors, desperate for good news this fall, bid up shares of Alexion on Friday not because it had good clinical data, positive sales trends, or a deal to announce. Instead, the rare disease company's shares rose as much as 12 percent because it canceled a public appearance.

Alexion was slated to attend the Credit Suisse Healthcare Conference this week but backed out. These aren't major events, generally. Investor relations people hold one-on-one meetings, and there's no public Q&A portion. So why drop out? "Something came up," Alexion told Leerink analyst Geoffrey Porges.

Through the rosy eyewear of investors, that means something positive is afoot. Perhaps even a buyout. The logic: Alexion's bean counters are in the midst of an all-hands-on-deck situation, forcing them to stay at their desks through the weekend for the crossings of T's and dottings of I's.

A similar boomlet happened last year when Acadia Pharmaceuticals canceled an appearance at a Roth Capital Partners meeting, sending the firm's shares up more than 15 percent.

No deal ever materialized there, and that's the most likely outcome for Alexion, too. But it in a rough market, even a glimmer gets refracted.

More reads

  • The mood among biotech investors has gone from dim to depressive. (TheStreet)
  • Nestlé bought a $145 million stake in the allergy-focused biotech Aimnune. (Bloomberg)
  • Novelst T.C. Boyle imagines a world where CRISPRing people is commonplace. (New Yorker)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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