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Mark Pruzanski

#JPM20: Af­ter a year of NASH col­laps­es, all eyes on two biotechs

SAN FRANCISCO – It’s not quite Dewey defeats Truman, but Goldman Sachs calling 2019 “The Year of NASH” may well go down in the annals of worst biotech predictions.

Goldman Sachs slapped the label on weeks before 2019’s JP Morgan conference, projecting that long-discussed treatments for the obesity-driven condition suspected to lurk in millions of Americans would begin to bear fruit and investors would move accordingly. That did not quite happen.

“If you look at 2019, it was just a string of disappointing news,” Pascal Prigent, CEO of NASH-focused biotech Genfit, told Endpoints News in an interview.

The Year of NASH, or nonalcoholic steatohepatitis, became a year of NASH failures. Gilead failed two large Phase III trials. CymaBay went from a $1 billion company to a $100 million company after they found their drug was killing patients’ liver cells. Cirius withdrew an $86 million IPO bid after a disastrous readout. Industry-wide, there were few acqusitions in a market often projected to be worth $35 billion.

Gilead, after dominating the NASH discussion at the 2019 JPM, gave one quick mention to the program in their 2020 presentation before pivoting to other drugs.

“As promising as some of the mechanisms looked in earlier stages, when push comes to shove in large study settings, they just haven’t proven out,” Mark Pruzanski, CEO of the NASH-focused biotech Intercept, told Endpoints in an interview.

As biotech turns from 2019, the failures have refocused eyes away from Gilead and back toward two startups, both facing key events in the coming months: Intercept, which first alerted investors to NASH at JPM 2014, and the France-based Genfit.

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Over a decade in­to the mile­stone boom, it's time to ask. Just how of­ten do they re­al­ly pay off?

Those megabillion biobuck deals: Do they work? Are they ever paid?

It’s the question looming behind most biotech buyouts and licensing deals, which now almost always come stuffed with developmental, regulatory and sales milestones. Take Roche, which last month acquired a “breakthrough” anti-fibrotic drug for $390 million cash but $1 billion in earnouts and today inked global rights for Sarepta’s investigational Duchenne muscular dystrophy gene therapy for $1.15 billion cash but $1.7 billion in earnouts.

Analysts have tried to track and quantify these earnouts since they first took off a little over a decade ago. (Atlas’ Bruce Booth made a valiant effort in 2012). SRS Acquiomm has arguably the most comprehensive outlook. On behalf of sellers, they track buyers’ progress toward these earnouts. That gives them insight into what they estimate is half of all biotech M&As and they’ve begun publishing reports on that data.

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Alzheimer's break­through? Not so fast — ex­perts poke holes in da­ta un­der­ly­ing Chi­na's sur­prise ap­proval

No new drug has been approved for Alzheimer’s since 2003, and researchers endeavoring to change that have been greeted with a graveyard of failed therapies. So when Chinese regulators waved a treatment developed by an obscure biotech through to the market — albeit a conditional approval contingent upon confirmatory data — it makes sense that scientists who woke up to the news were more in doubt than in awe.

While several prominent Alzheimer’s experts threw their weight behind the seaweed-derived therapy, oligomannate (GV-971), others contacted by Endpoints News were much more skeptical. As Green Valley Pharma has yet to release full data of the single Phase III trial on which the decision was based, most are taking a wait-and-see stance while the company prepares to launch a second, global trial in early 2020.

Among the deluge of questions surrounding the surprise approval, two seem particularly crucial: Did Green Valley offer enough credible evidence to warrant an OK? And did the drug really work as the biotech claimed?

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Path to the top: What kind of ex­pe­ri­ence does it take to get tapped for the helm of a biotech?

We all know the narrative by now: One by one, Big Pharma execs are migrating to biotech in search of a higher level of focus, more direct impact, nimbler operating structure and equity. But is that anecdotal, or a quantifiable trend? What else is notable about this new generation of biotech execs?

Helping sketch that picture, Coulter Partners, a life sciences executive recruitment firm based in London, sifted through 50 of its recent biotech CEO appointments between Europe and the US and offered a glance of the collective profile of this group.

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Where does the sci­ence come from? The top 20 NIH-fund­ed in­sti­tu­tions in 2017

Editor’s note This is the first of a two-part series in Endpoints News on the top research institutions US and and the funding they rely on. We’ll be back soon with a measure on quality, with a whole new lineup of the top centers in the country.

The scientific research that underlies drug development doesn’t come cheap. While industry pays for a large chunk of it, federal funding — often in the form of grants from the National Institutes of Health — also constitute a significant source of money.

By looking at where the funding stream flows, we could get a better idea of where biomedical research is coming from. Every year, the NIH provides grants to 300,000 researchers across 2,500 universities, medical schools and other research institutes. Between them, they shared around $26 billion in funding in 2017.

A look at publicly available data suggests that much of this funding is, in a remarkably consistent fashion, concentrated in select elite universities.

Top 20 institutions with the most NIH funding

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