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.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

UCB adds on more pos­i­tive PhI­II da­ta for IL-17A/17F in­hibitor bimek­izum­ab, clear­ing a path to the FDA

A month after posting positive top-line data from their first Phase III trial of the IL-17A/17F inhibitor bimekizumab, Belgium’s UCB says they’ve added more upbeat results from their second late-stage test in moderate-to-severe plaque psoriasis.

That leaves the company on track for regulatory submissions in the middle of next year, says CMO Iris Loew-Friedrich.
Their drug beat out a placebo on the co-primaries — a 90% improvement in PASI 90 (the Psoriasis Area and Severity Index) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to placebo. Investigators also boasted of hitting some key secondaries.
UCB is angling to enter an increasingly crowded market space.
In their first of 3 Phase III studies for bimekizumab, researchers touted top-line wins on statistically significant results on clearing plaque psoriasis, including a victory over J&J’s IL-23 contender Stelara on key endpoints. The drug targets both IL-17A and IL-17F, a modification on the IL-17A strategy laid out for Taltz (Eli Lilly) and Cosentyx (Novartis). And the new group also includes J&J’s Tremfya and AbbVie’s Skyrizi.

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