Trump to un­veil pro­pos­al to re­duce prices on doc­tor-ad­min­is­tered drugs as midterms loom

Days away from a con­tentious midterm elec­tion bat­tle, the Trump ad­min­is­tra­tion is once again at­tempt­ing to throw its weight at ex­or­bi­tant drug prices, a hot but­ton is­sue the pres­i­dent has long ral­lied against but has so far done lit­tle about.

DC-based POLITI­CO re­port­ed last night that Trump is set to un­veil a pro­pos­al that would make sweep­ing changes to how Medicare pays for some drugs in a speech to the HHS on Thurs­day af­ter­noon, which some see as a ploy to dis­tract away from the Re­pub­li­can agen­da to over­haul Oba­macare.

The scourge of high drug prices has been met with ire on both sides of the aisle, with De­moc­rats lash­ing out at their GOP coun­ter­parts for not us­ing their con­trol of both Con­gress and the ex­ec­u­tive branch to com­pel changes to the free­wheel­ing fash­ion the in­dus­try op­er­ates on drug prices.  While on the cam­paign trail, both Hillary Clin­ton and Trump chas­tised drug­mak­ers for their pric­ing be­hav­ior and made pledges to hold the in­dus­try ac­count­able. And af­ter cap­tur­ing the pres­i­den­cy, Trump sus­tained his at­tack on the in­dus­try stan­dard of price hikes, pro­claim­ing drug­mak­ers were “get­ting away with mur­der.” In May, Trump an­nounced that drug com­pa­nies would make “mas­sive” price cuts with­in two weeks — none which ma­te­ri­al­ized. An analy­sis of brand­ed pre­scrip­tion drugs, re­leased by the As­so­ci­at­ed Press last month, found that for all in­tents and pur­pos­es it’s been busi­ness as usu­al for drug­mak­ers, with price hikes con­tin­u­ing to out­strip cuts. The on­ly sil­ver lin­ing is that the num­ber of in­creas­es has di­min­ished some­what, and are not as steep as in past years, the AP not­ed.

The mul­ti-pronged pro­pos­al that still needs re­fine­ment and pas­sage through the fed­er­al rule-mak­ing dock­et was sent to the White House last month, and is ex­pect­ed to save Medicare $17 bil­lion over five years, and shave the cost of cer­tain drugs by up to 30 per­cent, ac­cord­ing to POLITI­CO. The plan in­tends to uti­lize Medicare’s in­no­va­tion cen­ter to ne­go­ti­ate the prices for some drugs that are di­rect­ly ad­min­is­tered by doc­tors — not pre­scrip­tions pur­chased by pa­tients at phar­ma­cies — in a bid to keep them on par with low­er prices paid by oth­er na­tions, ac­cord­ing to the re­port.

The pro­pos­al will al­so out­line an “in­ter­na­tion­al pric­ing in­dex,” in which Amer­i­can drug prices would be bench­marked against 16 oth­er na­tions — such as Cana­da, Czech Re­pub­lic, Fin­land, France, Ger­many, Japan, Spain, Swe­den and the Unit­ed King­dom — where tar­get drug prices are col­lec­tive­ly 44 per­cent low­er. Prices would slow­ly be low­ered to in­ter­na­tion­al lev­els over five years. How­ev­er, this part of the pro­pos­al may run in­to trou­ble as many drug­mak­ers aren’t par­tic­u­lar­ly forth­com­ing about the prices they set­tle on for their drugs fol­low­ing ne­go­ti­a­tions with for­eign gov­ern­ments.

An­oth­er part of the new plan in­cludes let­ting pri­vate sec­tor ven­dors ne­go­ti­ate with drug­mak­ers, akin to how health in­sur­ers ne­go­ti­ate prices in Medicare’s part D pro­gram. Medicare would test this ap­proach for cer­tain ex­pen­sive drugs in cer­tain ge­o­graph­ic ar­eas, where par­tic­i­pa­tion would be manda­to­ry for physi­cians and hos­pi­tals. In ad­di­tion, of­fi­cials in­tend to amend the in­cen­tive doc­tors have to pre­scribe ex­pen­sive drugs. Amend­ing that sys­tem to a flat fee, in con­trast to a per­cent­age, could com­pel doc­tors to use the most ef­fec­tive rather than the most ex­pen­sive treat­ments, POLITI­CO said.

In 2016, Pres­i­dent Oba­ma at­tempts to af­fect change in­to the way physi­cian-ad­min­is­tered drugs were paid for fiz­zled out af­ter be­ing thwart­ed by De­moc­rats and Re­pub­li­cans alike, not to men­tion doc­tors, hos­pi­tals and the über-con­nect­ed drug lob­by. De­spite Trump’s sus­tained brava­do, his lat­est pro­pos­al may suf­fer a sim­i­lar fate.

The speech, Trump’s first ad­dress to the health de­part­ment, is ex­pect­ed at 2 pm. It fol­lows some mod­est, al­beit in­di­rect, suc­cess­es for the ad­min­is­tra­tion in push­ing back at the phar­ma­ceu­ti­cal in­dus­try.  This month an HHS pro­pos­al re­quir­ing drug­mak­ers to re­veal prices in their TV ads came to the fore, in ad­di­tion to the pas­sage of a law ban­ning gag-claus­es, which pre­vent phar­ma­cists from in­form­ing cus­tomers when it’s cheap­er to pay in cash for a drug in­stead of us­ing in­sur­ance, as STAT not­ed.

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes more than a week af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.