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Wednesday, August 23, 2017

The Readout by Damian Garde & Meghana Keshavan
Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. On Twitter: @damiangarde@megkesh, and @statnews.

How to exploit regulatory loopholes

It’s a rather vexing ordeal these days for drug companies to woo physicians, thanks to that pesky Sunshine Act. But one gene therapy biotech has managed to sidestep reporting its dalliances with doctors to the federal government — despite providing a $3,000 honorarium, lodging, and travel costs. How? 

The company’s taking advantage of a loophole in the regulatory system, as STAT’s Ed Silverman reports. Because its gene therapy for spinal muscular atrophy has not yet achieved marketing clearance, it’s off the hook in terms of reporting to the government’s Open Payments system. 

While it’s not illegal, many consider the practice distasteful — and it “puts established companies who are complying with the law at a competitive disadvantage,” a former Senate staffer who helped write the Sunshine Act told STAT.

Read more on STAT Plus.

A lesson in analyst exuberance

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Diamonds in the rough or lambs to the slaughter?

The smart people at EP Vantage took a look at what analysts peg as the most valuable biotech drugs not yet partnered with pharma. Using their data, we pulled out the six that seemed a little baffling.

In the chart above, the blue bars represent the dollar figures that sell-side analysts have attached to each company’s lead drug — expressed in net present value, or NPV, which is meant to account to for risks and expenses. The red bars represent each company’s current value on the public market.

As you can see, something is amiss. Either each of these firms is being considerably, if not absurdly, undervalued by investors. Or, perhaps more likely, biotech analysts might have outpaced reality just a bit when it comes to these six drugs. We’ll leave it to you to decide.

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FDA: Wood-flavored drugs are not copacetic

Well, this is a bit of a ding for the merits of cut-rate medications: A compounding facility run by Imprimis Pharmaceuticals just got a warning letter from FDA, as RAPS points out. Samples of the drugs were tainted with “fibrous material consistent with wood” last year, and inspectors were not impressed with their cleaning and disinfecting procedures. 

Imprimis, if you recall, first announced it’d manufacture a $1 compounded version of Daraprim, the infamous toxoplasmosis drug sold by Turing Pharmaceuticals and Martin Shkreli. Perhaps there’s a reason drugs cost a bit more than that. 

An entrepreneurial approach to the opioid crisis

As the scourge of opioid abuse spreads across the country, Ohio has been particularly hard hit, with more than 4,000 fatal overdoses last year alone. So the state has launched a $20 million fund to back startups with ideas for addressing the crisis.

As STAT's Max Blau reports, the state has been flooded with proposals from biotech and device firms. They're pitching painkillers without addictive risk, drug-eluting implants, wristbands to track patients who get opioid prescriptions, and apps that attack various aspects of the problem.

Read more on STAT Plus.

And while you're at it, check out Max's new piece on one highly touted detox device known as the Bridge — and the doctor who ginned up nationwide hype to promote it, without solid evidence that it works.

More reads

  • The best — and worst — biotech IPOs in the class of 2017. (Endpoints)
  • Prices for cholesterol drugs would have to drop a lot to be cost effective. (STAT Plus)
  • Lilly pens deal for Evotec spinout’s immune tolerance drugs. (FierceBiotech)
  • Study: Knowing more doesn't change disbeliefs about science. (Axios)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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