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Wednesday, June 29, 2016

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, your daily glimpse at what's happening in biotech. Today, we talk gender diversity in biotech investing, diagnosing disease from the sound of a voice, and the fast-paced market for hepatitis C cures. Need more? Visit statnews.com and follow us on Twitter.

'You sound sick' could be an actual diagnosis

it's not what you say, but how you say it, say entrepreneurs trying to diagnose disease from your vocal tics. (APSTOCK)

There's a growing push among academics and entrepreneurs to figure how to use the human voice as a marker of disease. Respiratory ailments, depression, heart disease — all could potentially be detected by listening closely to how patients talk. At least in theory. STAT's Rebecca Robbins dug into the idea, looking at the promises and potholes in the field of vocal diagnostics. Read more.

Esperion and the perils of an ‘evolving landscape’

About a year ago, Esperion Therapeutics was a biotech starlet. The small Michigan company had a pill it said could lower bad cholesterol nearly as well as new injectable drugs from Sanofi and Amgen. It planned to win market share from the giants with two clinical tests: A small one to prove efficacy in patients with seriously high cholesterol, and then a larger study on a broader group.

But that’s not looking like a sure bet anymore. 

On Tuesday night, Esperion said the FDA had thrown a wrench in its plan. Specifically, the agency wouldn’t commit to approving Esperion’s drug based on its cholesterol-lowering ability. The FDA may hold out instead for data from that larger study, which will test whether the drug reduces the risk of heart attack and stroke — but which won’t be ready until 2022. And Esperion has only enough cash to keep the doors open through 2019.

The problem is “a potentially evolving landscape” in the cardio field, Esperion CEO Tim Mayleben said in a statement.

His company’s read of the FDA’s mood has evolved as well. In August 2015, Esperion stated outright that it would not need to complete the big study to win approval. A month later, that language grew to include a “could.” Now this. All of which is to say, a lot might change between now and 2022.

Hawk the pain away

Livia is a "is a drug-free solution" for menstrual pain that works by closing the body's "pain gates," if you ask the company that makes it. (iPulse Medical)

Perhaps you’ve heard of Livia, a self-proclaimed “off switch for menstrual pain,” which has garnered breathless headlines for its promise to “end your period pain FOREVER” and “save you from your uterus.” It has more than 8,500 backers on Indiegogo and has raised more than $782,000.

What it doesn’t have is the approval of regulators in the US or Europe. The company behind Livia says it’s “near completion” with the FDA and European processes but didn’t respond to questions from STAT about just what that means. The firm, iPulse Medical, promises to begin shipping the $85 device in October.

Livia is part of a growing trend in which medical device inventors use crowdfunding sites to solicit investments before developing a prototype, much less securing regulatory approval. As STAT reported last year, such projects sometimes fail outright, and for backers, there are no refunds.

(Oh, and for the record: Livia’s magical menstrual off switch boils down to transcutaneous electrical nerve stimulation, a well-understood technology that uses pulses of energy to treat pain. Looking at clinical data, the method is generally safe, and sometimes it even works.)

First, can we stop calling it ‘bikini medicine?’

It’s no secret: Healthcare financiers are, by and large, male. Women represent the biggest chunk of the industry’s customers, however — and are starting to invest in the sector. A new Bloomberg piece on “bikini medicine” (ugh) highlights this trend nicely, with a focus on women's health companies. 

The piece cites Cindy Whitehead, known best for her role as CEO of Sprout Pharmaceuticals, which developed the “female Viagra,” Addyi. “It was an advantage for me to be a woman leading Sprout,” Whitehead told Bloomberg. “Women shared their stories with me. We did a year of diligence and just by listening I had such a better appreciation of the devastation for women [of low libido]."

It must be noted, however, that Whitehead's devotion to gender equity had its limits. The alcohol safety testing trials for Addyi were done in just two women — and 23 men

Gilead, Bristol-Myers and the blistering pace of hep C innovation

Gilead Sciences extended its dominance over the market for hepatitis C treatments, winning FDA approval for the first one-pill therapy that can cure all six forms of the virus, as STAT's Ed Silverman reports. List price for the 12-week regimen: $74,760.

That’s a lot, but it’s a lot less than what it previously cost treat genotype 3 hep C, the second most common form of the virus. The old standard of care was a combo of Gilead's Sovaldi, which sells for $84,000, and Bristol-Myers Squibb’s Daklinza, which ships for $63,000. 

All this means more than just a welcome new spigot of cash for Gilead. It means that Bristol-Myers, just 11 months removed from its own FDA approval, could soon be on the outside looking in on the fast-paced and lucrative hep C market. Ask Vertex what that feels like.

More reads

  • What six former FDA commissioners advise their successor. (STAT)
  • Novartis is paying Xencor $150 million up front to collaborate on antibody treatments for blood cancer. (EP Vantage)
  • Belgian biotech Celyad failed in its attempt to treat heart failure with re-engineered cells. (Press release)
  • Infinity Pharmaceuticals, gradually shrinking after a series of clinical setbacks, is laying off another 100 employees. (Boston Globe)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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