Friday, October 21, 2016

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we bring you the latest in biotech. Follow us on Twitter: @damiangarde@megkesh, and @statnews


How biotechs teach old drugs new tricks

Some biotech startups are born on second base, licensing drugs left behind by larger companies instead of starting from scratch. The latest to give it a try is BlackThorn Therapeutics, a new company whose top asset is an Eli Lilly-invented therapy that previously failed a pair of trials in depression and alcohol dependence. 

STAT talked to BlackThorn CEO Dr. Mark Corrigan about the virtues and risks of picking up where pharma has left off.

Where’d you get the notion of in-licensing a waylaid drug?

I was on the board of Cubist Pharmaceuticals, and they had a billion-dollar drug — Cubicin — that Lilly had shelved due to toxicity. You watch that lesson unfold and you think, “Ah, maybe this is a real hunting ground." What we’re trying to take advantage of is, if you look at the exodus from neuroscience by Big Pharma, there are some really promising assets out there, and they’re very well developed. If you can access a big pharma asset, specifically one that’s been left, you have this fabulous sort of background package.

How do you find promising drugs languishing on the shelf?

For us, we were interested in a number of assets, and amongst them was Lilly’s program. And it was through Arch Venture Partners [BlackThorn’s founding investor] that we were able to contact them. And that’s sort of how it goes. The other way it happens is sometimes you find champions of the drug who have left those companies, and they say, “Boy, you know, I really believed in this program but the company decided not to fund it.”

Here’s a really obvious question: If these drugs are so valuable, why is pharma willing to part with them?

I think that’s the right question for investors to ask, and for us the answer to is that Lilly strategically exited the space, rather than “this has some hidden wart on it that’s horrible.” I don’t know if it’s a trend, but it feels that way in part because as large companies focus their research, they recognize that there’s an ecosystem of small companies that may be able to bear the risk and raise the funds to advance these assets where they can’t. Years ago, when I was at Pharmacia and Upjohn, you were actually terrified of out-licensing molecules because if they hit a home run, there’s egg on your face. We would have rather let them rot on our shelves. I think that’s changed.

Biogen's plans for pain lose their luster

Speaking of spin-off drugs, a pain treatment that began life at GlaxoSmithKline found its way into a startup called Convergence Pharmaceuticals, only to trade hands again. Last year, Biogen paid $200 million in cash to get its hands on the pain drug, and pledged to pay as much as $475 million more if it panned out. The company saw the therapy as a big earner in the future.

But that’s not terribly likely, according to Leerink analyst Geoffrey Porges. Leerink consulted some pain specialists and found little enthusiasm for Biogen’s drug, which is slated for late-stage development in nerve pain this year. When modeling Biogen's financial outlook, Porges had to weigh whether to include revenue from the drug. "In a word, our conclusion is no,” he wrote.

Biogen’s treatment is part of a promising but troubled class of therapies that target Nav1.7, a protein that plays a role in pain signaling. Pfizer shelved one such drug last year after encountering mixed clinical results, but groups at Amgen and Genentech are pushing forward with early-stage efforts.

$109 million and counting

That's how much drug companies have poured into defeating a California ballot initiative that would cap the prices the state pays for some drugs, new filings show.

Facing off against pharma: Bernie Sanders, who has gotten quite adept at tanking drug makers' stock with a single tweet.

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Time to splurge on that treadmill desk

why can't someone finally prove that being a couch potato is good for you? (stat / matthew orr)

A quick jog could help you think better.

Researchers are finding that working out — not just walking, but a few days a week of moderate exercise — helps improve cognition right away. That's because when you get moving, your muscles release chemicals that wend their way into your brain — and may help grow new neurons. 

In a new episode of Science Happens!, STAT's Carl Zimmer chats with NYU psychologist Wendy Suzuki about the links between exercise and brain power.

Watch here.

What does it take to get the FDA to approve a depression drug?

That’s what Alkermes is soon to find out, as it prepares to take a twice-failed, once-successful treatment for major depressive disorder before regulators.

The drug, ALKS-5461, failed in a pair of late-stage trials in January, nearly halving Alkermes’ share price and convincing some analysts to write it off outright. But in a third study, the drug met its main goal by significantly beating out placebo in improving symptoms of depression, Alkermes said Thursday. And now the company plans to bring pooled data from all three studies to the FDA to see whether ALKS-5461 might be approvable.

Will the agency accept two misses and one hit? In the past, companies have needed at least two late-stage successes to sway the FDA. But major depressive disorder is a particularly dire diagnosis, and Alkermes studied its drug on patients for whom standard therapies were little help. Investors, who sent the company’s shares up by about 50 percent on Thursday night, seem to think ALKS-5461 has shot.

More reads

  • Gilead Sciences is pushing its lead NASH drug into Phase 3 despite some uneven clinical results. (TheStreet)
  • Roche isn't looking to do any blockbuster deals in the near future, according to its CEO. (Bloomberg)
  • A startup developing organs on a chip raised $45 million in venture cash. (Forbes)
  • How does the FBI police do-it-yourself biology labs? (MIT Technology Review)

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Thanks for reading! Until next week,

Damian & Meghana

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