Large coali­tion joins drug lob­by in de­nounc­ing Trump pro­pos­al to im­port drug prices for Medicare

Trump’s Oc­to­ber pro­pos­al to peg drug prices to over­seas rates for Medicare ben­e­fi­cia­ries has elicit­ed the ire of not just the all-pow­er­ful bio­phar­ma lob­by, but al­so a large coali­tion rep­re­sent­ing 339 or­ga­ni­za­tions which ear­li­er this week de­tailed their con­cern, deem­ing the pro­pos­al an “un­prece­dent­ed, manda­to­ry ex­per­i­ment” that could ir­repara­bly af­fect the 59 mil­lion Amer­i­cans who re­ly on the Medicare Part B pro­gram.

The HHS pro­pos­al — de­signed to save Medicare more than $17 bil­lion over five years — was re­vealed in late Oc­to­ber ahead of a con­tentious mid-term bat­tle. As part of the plan, the agency out­lined an “in­ter­na­tion­al pric­ing in­dex (IPI)” in which prices for drugs uti­lized by Medicare — the world’s largest drug pur­chas­er — would be bench­marked against oth­er na­tions, in­stead of the way drugs are cur­rent­ly priced: by cal­cu­lat­ing the av­er­age sales price and adding 6% for the providers who man­age the drug sup­ply. Es­sen­tial­ly, in­stead of al­low­ing cheap­er drugs to be im­port­ed in­to the Unit­ed States, Trump’s ba­sic plan is to hold on to the drugs and im­port the price.

Da­ta sug­gests that the Unit­ed States spends near­ly twice as much as 10 high-in­come coun­tries on health care — dri­ven by high cost of la­bor and goods, in­clud­ing phar­ma­ceu­ti­cals and de­vices — but ac­tu­al­ly per­forms worse on a num­ber of pop­u­la­tion health out­comes.

Fac­ing an un­prece­dent­ed change to the sta­tus quo by the po­ten­tial im­po­si­tion of for­eign price con­trols on US shores did not, un­sur­pris­ing­ly, in­spire cheer from the drug lob­by, with PhRMA and BIO is­su­ing state­ments dis­play­ing their con­tempt for the plan. On Mon­day, the Part B Ac­cess for Se­niors and Physi­cians (ASP) coali­tion wrote to top Wash­ing­ton law­mak­ers ex­press­ing con­cern that the mod­el would be a net neg­a­tive for pa­tients and providers, but like­ly a pos­i­tive for the bot­tom lines of ven­dors such as PBMs.

“Use of for­eign pay­ment poli­cies risks im­port­ing ac­cess de­lays to Medicare ben­e­fi­cia­ries, lim­it­ing pa­tient choice of provider, and po­ten­tial­ly im­ped­ing de­vel­op­ment of more ef­fec­tive med­i­cines for pa­tients. The pro­posed mod­el would put ven­dors with no clin­i­cal or med­ical ex­per­tise be­tween pa­tients and doc­tors. Ven­dors would in­evitably im­pose re­stric­tions on ben­e­fi­cia­ry ac­cess to drugs through for­mu­la­ries, dis­rupt­ing or de­lay­ing care in the pur­suit of prof­it,” they wrote.

The IPI mod­el could al­so slash ac­cess to treat­ment, they said, cit­ing a re­cent analy­sis that sug­gests the Unit­ed King­dom’s NICE en­sured near­ly 92% of on­col­o­gy treat­ments were sub­ject­ed to ac­cess re­stric­tions be­tween 2013 and 2017.

How­ev­er, de­spite hav­ing faster ac­cess to treat­ment in the Unit­ed States, crit­ics have ar­gued that a num­ber of drugs that are sanc­tioned ap­proval by the FDA do not con­fer large enough ef­fi­ca­cy im­prove­ments over ex­ist­ing med­ica­tions to war­rant the prices they com­mand, which ex­plains why agen­cies such as NICE de­lay or re­ject their do­mes­tic adop­tion.

Trump has long chas­tised drug­mak­ers for “get­ting away with mur­der,” and this pro­pos­al is one of the two that have been re­leased in re­cent months. But Trump’s gen­er­al brava­do against the phar­ma in­dus­try may not nec­es­sar­i­ly trans­late to ma­te­r­i­al change. In the first nine months of 2018, there were 96 price hikes for every price cut, ac­cord­ing to an analy­sis by the As­so­ci­at­ed Press pub­lished this Sep­tem­ber, and more re­cent­ly Pfiz­er $PFE said it planned to in­crease prices on 41 of its drugs in Jan­u­ary.


Im­age: Don­ald Trump. WHITE HOUSE BROAD­CAST

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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