End­points Video spot­light: The de­bate over drug pric­ing takes cen­ter stage in 2017

If you thought the drug pric­ing de­bate looked big in 2016, wait for what 2017 has in store for you.

At JP Mor­gan ear­li­er this month, End­points News gath­ered to­geth­er some of the top in­dus­try play­ers to dis­cuss the lat­est news on pric­ing strate­gies as well as dif­fer­ent per­spec­tives on what it’s go­ing to take to sat­is­fy the grow­ing pub­lic de­mand for price re­forms.

This was just be­fore Pres­i­dent Trump lined up a broad­side that would rat­tle every win­dow in phar­ma.

What­ev­er di­rec­tion this goes on Capi­tol Hill, it’s quite cer­tain that the in­dus­try will no longer be al­lowed to qui­et­ly en­gi­neer steep and steady price hikes, though that may de­pend on your de­f­i­n­i­tion of “steep.” But what’s to be done with the price gougers when there’s no law pre­vent­ing any­one from overnight price hikes of 5,000%? And how will drug com­pa­nies han­dle the next con­tro­ver­sy over stick­er shock?

The End­points team gath­ered a few clips from the break­fast to of­fer a fla­vor of what’s be­ing dis­cussed. It’s clear that the de­bate has a long way to run, though, be­fore it’s played out.

We al­so have the en­tire 52-minute pan­el dis­cus­sion avail­able for e-mail sub­scribers. (There’s nev­er any cost to read End­points.)


End­points Ed­i­tor John Car­roll breaks it down

There does seem to be sev­er­al dif­fer­ent con­tro­ver­sies about pric­ing. There’s not just one.


Alk­er­mes CEO Richard Pops of­fers a dif­fer­ent per­spec­tive

I come to it al­most like a Mar­t­ian from Mars com­ing to say, “How does this whole thing work?” It’s so bizarre be­cause, I must ad­mit, I don’t think any of us re­al­ized how fre­quent­ly phar­ma­ceu­ti­cal com­pa­nies were in­deed rais­ing prices over the last decade or so.


Al­ler­gan CEO Brent Saun­ders on gross vs net prices

(T)he 20-some­thing drugs that we in­creased in Jan­u­ary, was an av­er­age of about 7.5% price in­crease, but that’s gross. The net was clos­er to two to three.


Pops and Saun­ders talk val­ue-based pric­ing

I would love to see a com­pa­ny come to mar­ket with a high-priced drug, quote un­quote, and pro­vide both a qual­i­ta­tive and quan­ti­ta­tive jus­ti­fi­ca­tion for the way they priced it. Be­cause peo­ple hate the opac­i­ty.


J&J’s Joaquin Du­a­to on gener­ics and biosim­i­lars

In the next five years, we’re go­ing to be fac­ing around $150 bil­lion of med­i­cines that are go­ing to lose patent and that’s go­ing to be a source of reg­u­lat­ing the mar­ket from an­oth­er per­spec­tive.


PhRMA CEO Stephen Ubl has a plan

We’re go­ing to launch a very am­bi­tious, com­pre­hen­sive, na­tion­al com­mu­ni­ca­tions and pub­lic af­fairs ef­fort.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Federico Mingozzi (Spark)

Spark touts an­i­mal da­ta for a so­lu­tion to AAV gene ther­a­py's an­ti­body prob­lem

Among all the limitations of using an adeno-associated virus as a vector to deliver a gene — still the most established modality in gene therapy given years of trial and error and finally success — the presence of neutralizing antibodies, whether pre-existing or induced, looms large.

“When I think about the immune responses in AAV, I try to sort of layer them,” Federico Mingozzi, the CSO at Spark Therapeutics, told Endpoints News. “The antibody is the first layer. It’s the first block that you find when you’re trying to do gene transfer.”

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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