Trump is kick­ing the can down the road to­day, avoid­ing any tough pre­scrip­tions on drug pric­ing

BIOREG­NUM — The view from John Car­roll

John Car­roll

Pres­i­dent Don­ald Trump has found the en­e­my on drug prices, and they’re out­side our bor­ders.

Ad­min­is­tra­tion of­fi­cials of­fered re­porters a pre­view of Trump’s speech this af­ter­noon, and the de­tailed notes pro­vid­ed in a slate of sto­ries about the back­grounder in­cludes the pres­i­dent’s as­sault on oth­er coun­tries’ sin­gle-pay­er sys­tems. Those coun­tries, or rather the rest of the in­dus­tri­al­ized world, he says, have been “free-rid­ing” on the US, where high drug prices sub­si­dize an in­dus­try forced to cut prices abroad.

It’s un­cer­tain how a full throat­ed roar against “so­cial­ist” drug pric­ing poli­cies will do any­thing to cut US prices — or if rais­ing prices abroad would even help achieve the ad­min­is­tra­tion’s goal of low­er­ing out­lays for drugs here. But po­lit­i­cal­ly the pres­i­dent’s planned speech this af­ter­noon is shap­ing up as a ma­jor win for a bio­phar­ma in­dus­try that has been scram­bling to get out of the way of a threat­ened po­lit­i­cal avalanche.

In­stead of a full-scale frontal as­sault against com­pa­nies that have been “get­ting away with mur­der,” this ad­min­is­tra­tion is kick­ing the can down the road for an­oth­er day.

There are oth­er mea­sures in­clud­ed in the Trump plan, to be sure, but they in­volve chang­ing gov­ern­ment rules that shape what Medicare re­cip­i­ents pay. I’ll get to that in a sec­ond. First, it’s im­por­tant to note what is not in the plan.

Pri­mar­i­ly, there’s no pro­vi­sion seek­ing au­thor­i­ty to get Medicare start­ed on ne­go­ti­at­ing drug prices — let alone a pro­pos­al for a Medicare for­mu­la­ry to lever­age low­er prices. There’s al­so no move to gain an ap­proval to al­low for im­port­ing drugs from oth­er coun­tries where prices are low­er.

That stands as a big win for the in­dus­try lob­by­ists, as ei­ther move could pave the way to a change­up in the pric­ing struc­ture. In the past, Trump has voiced his sup­port for Medicare price ne­go­ti­a­tions, trig­ger­ing con­sid­er­able fret­ting among man­u­fac­tur­ers who re­ly on this coun­try to pro­vide the bulk of their prof­its.

The thrust of the pres­i­dent’s pro­posed poli­cies will be to get “gov­ern­ment rules out of the way that are pre­vent­ing se­niors from get­ting bet­ter deals.”

To do that, it ap­pears the pres­i­dent wants to con­tin­ue a push that would al­low Medicare Part D plans some room to fash­ion more cre­ative drug plans, end rules that en­cour­age doc­tors to pre­scribe prici­er meds and try to force phar­ma­cy ben­e­fit man­agers to share more of their re­bates from man­u­fac­tur­ers with mem­bers. Look for more out­comes pric­ing strate­gies in Medicare.

When you in­flate drug prices it gives ben­e­fit man­agers a chance to take a slice of a big­ger dis­count for them­selves, while al­so adding to out-of-pock­et ex­pens­es. This gets at the in­dus­try’s crit­i­cism that much of the prob­lem with the cur­rent pric­ing sys­tem is that ben­e­fit man­agers rigged the game to line their own pock­ets at con­sumers’ ex­pense. 

But you’ll no­tice that Trump’s fo­cus is on some of the rules for how the game is played, rather than on the game it­self. This tweet from Walid Gel­lad — an as­so­ciate pro­fes­sor of med­i­cine and health pol­i­cy at the Uni­ver­si­ty of Pitts­burgh, where he leads the Cen­ter for Phar­ma­ceu­ti­cal Pol­i­cy and Pre­scrib­ing — un­der­scores the gist of it, where the fo­cus is on who pays rather than on what every­one pays.

In ad­di­tion, it looks like we’ll see a push­back against any prac­tices that al­low man­u­fac­tur­ers to de­lay or pre­vent cheap­er com­pe­ti­tion from gener­ics and biosim­i­lars. FDA com­mis­sion­er Scott Got­tlieb has been help­ing on that front by tack­ling a back­log of gener­ics ap­pli­ca­tions.

Add it all up, and what you see here is some im­por­tant, though lim­it­ed, tin­ker­ing with a sys­tem that leaves the cur­rent drug pric­ing sys­tem baked in. Bio­phar­ma com­pa­nies will like­ly cel­e­brate all this qui­et­ly to­day. 

At some point, as an­a­lysts like David Maris have not­ed, the pres­sure to re­form drug prices may grow to the point where price con­trols are adopt­ed. 

But af­ter rail­ing against drug prices for months, Trump’s un­will­ing­ness to push Medicare price ne­go­ti­a­tions leaves pric­ing pow­er in the hands of the in­dus­try. And that means old drugs like Hu­mi­ra will con­tin­ue to cost more each year, while the stick­er shock for new ones will con­tin­ue to rat­tle the pub­lic.

This is­sue is far from re­solved. 

Im­age: Pres­i­dent Don­ald Trump in 2017. SHUT­TER­STOCK

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.

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.

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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Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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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.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.

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.

Mike Grey. Mirum

In $86M IPO pitch, Mirum spells out plans to turn Shire dis­cards in­to or­phan liv­er drug suc­cess­es

Mike Grey doesn’t have any time to waste. Hav­ing re­gained con­trol of two liv­er dis­ease drugs from Shire and po­si­tioned them for piv­otal stud­ies — five years af­ter first hand­ing them off in a deal to sell Lu­me­na, where he was CEO — Grey is steer­ing Mirum straight in­to an IPO with a $86 mil­lion ask.

Not that Mirum has spent much of its $120 mil­lion Se­ries A cash since launch­ing last No­vem­ber. Ac­cord­ing to the S-1, the Cal­i­forn­ian biotech has burned through $23.3 mil­lion as of March, but ex­pects ex­pens­es to pick up once their clin­i­cal work gath­ers steam.