Tuesday, August 23, 2016

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, your daily note from the world of biotech. Follow us on Twitter for more: @damiangarde@megkesh, and @statnews.

CAR-T therapy: Risk vs. reward

Car-t therapy: unleashing an army of frankensteinian cell assassins. (NIH)

There’s no denying that CAR-T could be a superbly effective addition to the arsenal of cancer-killing therapies. It saved the life of New Jersey teacher Karen Koehler. But the thing is — it also very nearly killed her.

Engineering your own T-cells to attack your own cancer is proving to be a dangerous, but rewarding, game. The treatments can induce such sudden and severe side effects that it's hard to imagine CAR-T could be deployed anywhere besides an elite academic center.

What are the realities of bringing CAR-T — safely — to the bedside? Could it ever become as common as, say, chemotherapy? 

Read more.

Is this what sets off a biotech buyout spree?

It was supposed to be a blockbuster summer in biotech, with pharma bidding wars aplenty, sparked by declining valuations for mid-size companies.

And then it didn’t happen.

But yesterday’s news that Pfizer is paying an eyebrow-raising $14 billion for Medivation could be the crack that breaks the levy, according to analysts. Sanofi, left at the altar by Medivation, could spring for BioMarin. Tesaro, whose lead cancer drug works much like Medivation’s, could be the next domino to fall. And then there’s Biogen, the suddenly in-flux giant whose recent misfortunes have left it vulnerable to would-be acquirers. 

“We may be heading into deal-making season,” Jefferies analyst Brian Abrahams wrote in a note to clients. And, indeed, the Nasdaq biotech index crept up more than 2 percent yesterday. More on winners and losers from the Medivation deal here, from the San Francisco Business Times.

Checking in on a (possibly former) biotech unicorn

Earlier this year, Proteus Digital Health rose to a valuation above $1 billion thanks to the promise of its core technology: sensors that can be baked into pills and broadcast health data to patients and caregivers.

The bull case for Proteus hit a major roadblock in April, however, when the FDA rejected a version of the antipsychotic Abilify with the company’s proprietary sensors on board. Proteus and its partner, Japanese drugmaker Otsuka, have yet to reapply and haven’t set a timeline for doing so.

But the company is keeping the faith. The FDA has given Proteus the OK to sell a standalone sensor that can be swallowed separately from a drug and transmits information about the patient, including alerts about spikes in heart rates or drops in blood pressure. A children’s hospital in Dallas is putting the technology to use in a 75-patient study with plans to publish its findings next year. A hospital system in California has also adopted the technology.

And Proteus hasn't given up on the idea of marketing drugs that have a similar sensor embedded right in the medication.

"There's been a lot of interest, and we're going through each step of the process faster than we had ever envisioned,” Proteus Chief Commercial Officer Molly O'Neill told The Dallas Morning News. “We have every reason to believe this will be approved." 

That's awkward

"It is with great regret that I have been forced to sell shares in Concordia," said the founder and CEO of the biopharma company Concordia, which is in the middle of trying to sell itself after running into some alarming financial trouble.

Normally, selling 505,000 shares of your company, as Concordia's Mark Thompson did, would be illegal at this stage. But Thompson's trade was not really in his control. He had used the shares to secure a loan, the company said, and when Concordia's stock value dropped, the terms of the loan forced him to sell.

Still, not great, timing-wise.

More reads

  • Advaxis is back from the brink thanks to fresh promise for its immuno-oncology therapy. (STAT)
  • Regeneron signed a $8.9 million deal with the federal government to development antibodies for MERS. (Press release)
  • Apple acquired a company focused on gathering patient health data. (Fast Company)
  • Ireland's DS Biopharma is spinning out its in-development NASH therapy into a company all its own. (FierceBiotech)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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