In his lat­est broad­side on drug prices, Trump plays the Medicare ne­go­ti­a­tions card

Don­ald Trump plans to use the mas­sive lever­age of Medicare and Med­ic­aid spend­ing as a tool to rein in prices — a tac­tic that has long been feared by bio­phar­ma.

In an in­ter­view late Sat­ur­day with the Wash­ing­ton Post, the pres­i­dent-elect al­so said he was putting the fi­nal touch­es to a new “in­sur­ance for every­one” plan to re­place Oba­macare, though he de­clined to pro­vide specifics.

Trump set off a 5-alarm in­dus­try­wide fire alert last week when he in­sist­ed dur­ing an im­promp­tu di­a­tribe dur­ing his press con­fer­ence that phar­ma com­pa­nies had been “get­ting away with mur­der” on drug prices, which he vowed to end once he gets in of­fice in a few days. In the most re­cent in­ter­view, he piled on the bio­phar­ma in­dus­try, in­sist­ing that low­er­ing drug prices was cen­tral to mod­er­at­ing the price of health­care and the in­sur­ance need­ed to cov­er care.

“They’re po­lit­i­cal­ly pro­tect­ed, but not any­more,” he told the Post about phar­ma, adding lat­er that he was un­con­cerned about the po­ten­tial dis­rup­tion in stock prices. And that’s a com­ment that could weigh heav­i­ly on stocks as an­a­lysts pon­der the im­pact.

While Trump touched on di­rect Medicare ne­go­ti­a­tions dur­ing the elec­tion, many of the most in­flu­en­tial lead­ers of the in­dus­try had thought that they were in a still cozy spot with the in­com­ing ad­min­is­tra­tion, with time to pur­sue a ne­go­ti­at­ed peace af­ter brand­ed drug prices had es­ca­lat­ed rapid­ly in re­cent years. In­stead, phar­ma ex­ecs find them­selves pil­lo­ried by a soon-to-be-pres­i­dent as he spurs pop­ulist wrath in fa­vor of con­tro­ver­sial changes to health­care pol­i­cy.

That be­came clear dur­ing his re­cent press con­fer­ence:

“Our drug in­dus­try has been dis­as­trous. They’re leav­ing left and right. They sup­ply our drugs but they don’t make them here, to a large ex­tent. And the oth­er thing we have to do is cre­ate new bid­ding pro­ce­dures for the drug in­dus­try. They’re get­ting away with mur­der. Phar­ma has a lot of…lob­by­ists and a lot of pow­er and there’s very lit­tle bid­ding on drugs.

“We’re the largest buy­er of drugs in the world, and yet we don’t bid prop­er­ly. We’re go­ing to start bid­ding. We’re go­ing to save bil­lions of dol­lars over a pe­ri­od of time.”

Trump has a habit of speak­ing off the cuff, which can lead to some con­sid­er­able con­fu­sion. The main thrust of that com­ment was that he was fo­cus­ing on low­er­ing the price of meds, rather than tar­get­ing the glob­al drug man­u­fac­tur­ing net­work or ac­tu­al­ly es­tab­lish­ing a tra­di­tion­al kind of bid­ding mech­a­nism for fed­er­al con­tracts. In the Post in­ter­view, though, Trump al­so said that he want­ed to see more drug man­u­fac­tur­ing in the US. And he seemed pre­pare to un­cork his Twit­ter guns to help make that hap­pen.

Medicare has been pre­vent­ed by law — or, per­haps more ac­cu­rate­ly, at the in­sis­tence of law­mak­ers — that it not ne­go­ti­ate di­rect­ly on the price of a drug, though fed­er­al ben­e­fit man­agers do that on their own ac­cord. Those net prices, though, are not pub­lic.

If Medicare does di­rect­ly ne­go­ti­ate deep dis­counts, with per­haps the great­est lever­age among all buy­ers, it could well set up a trans­par­ent base­line on drug prices that every­one could work with, while al­so dri­ving new ini­tia­tives pre­vent­ing state gov­ern­ments from pay­ing more. And that could well wind up cost­ing drug man­u­fac­tur­ers dear­ly, far more than the sin­gle dig­it an­nu­al hikes many had hoped to use as a com­pro­mise for re­spon­si­ble pric­ing prac­tices.

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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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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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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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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No­var­tis chips in $10M for IPO-bound part­ner Pli­ant; Tenax shares soar on heart drug da­ta

Novartis is coming in with $10 million to help support the looming IPO of a partner. Pliant Therapeutics posted a new filing with the SEC showing that Novartis is buying the shares at $15, the mid-point of the range. It’s adding several million shares to the offering, bringing the total to around $135 million. Biotech companies have been enjoying quite a run on virtual Wall Street, with investors boosting new offerings to some big hauls.

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.”