Mer­ck’s bad day: $310M for Not­Petya, fran­chise drugs take a hit and now the EMA push­es back on Keytru­da

Mer­ck $MRK took a se­ries of hits on Fri­day, capped by news af­ter the mar­ket closed that its Eu­ro­pean ap­pli­ca­tion for its Keytru­da/chemo com­bo for front­line non-small cell lung can­cer was be­ing scrapped in the face of a push­back from the EMA.

In the morn­ing, rolling out its Q3 num­bers, Mer­ck was forced to con­cede that the Not­Petya cy­ber at­tack had cost the com­pa­ny $135 mil­lion in lost sales along with $175 mil­lion in re­lat­ed costs while forc­ing them to bor­row $240 mil­lion worth of Gar­dasil from fed­er­al stock­piles. That ex­tra $310 mil­lion in costs will be re­peat­ed in Q4, Mer­ck not­ed in their quar­ter­ly call, as over­all dam­ages roll up to the $1 bil­lion mark.

Dur­ing the call with an­a­lysts the com­pa­ny al­so not­ed: “We’ll have to wait ul­ti­mate­ly to see more about KEYNOTE-021G be­fore we can com­ment…”

As they not­ed in their terse re­lease late Fri­day, the Eu­ro­pean ap­pli­ca­tion was based on KEYNOTE-021G and Mer­ck felt it need­ed to clar­i­fy the sit­u­a­tion ahead of the for­mal push­back no­tice from Eu­ro­pean reg­u­la­tors, prompt­ing the late state­ment.

In a note Fri­day evening, Ever­core ISI’s Umer Raf­fat says that the Eu­ro­peans have been re­luc­tant to ap­prove drugs on Phase II da­ta. The FDA, mean­while, has made that stan­dard op­er­at­ing pro­ce­dure in on­col­o­gy.

Iron­i­cal­ly, the EMA has been fine with keep­ing PTC’s Duchenne MD drug ataluren on the mar­ket fol­low­ing an ac­cel­er­at­ed ap­proval, even though it’s failed a se­ries of stud­ies and was just slapped down for the third time by the FDA, which wants to see some re­al ev­i­dence of ef­fi­ca­cy be­fore hand­ing out a green light on mar­ket­ing.

Mer­ck’s surge to the top in NSCLC in the US af­ter a sna­fu at Bris­tol-My­ers Squibb forced a stum­ble on that front has helped make Keytru­da the star fran­chise play­er for the phar­ma gi­ant. Q3 rev­enue broke the $1 bil­lion mark, mak­ing Keytru­da the sec­ond largest fran­chise drug in the port­fo­lio.

Their num­ber one drug Janu­via is ex­pe­ri­enc­ing some pric­ing pres­sure, a fea­ture that will al­so start to crimp rev­enue from Zepati­er, which is set to see rev­enue slide in the face of de­clin­ing pa­tient vol­ume as more peo­ple with hep C are cured.

In­vestors re­act­ed the same way they greet­ed com­pet­i­tive pres­sures at Cel­gene and Gilead this week. Mer­ck’s shares dropped 6% dur­ing the day, and an­oth­er 2.3% in af­ter-mar­ket trad­ing as in­vestors shook their heads over the im­pli­ca­tions.

As I re­port­ed yes­ter­day, Mer­ck is al­so sig­nal­ing that it wants to do more big deals like the one it did with As­traZeneca on the can­cer drug Lyn­parza. Keytru­da as the lone stand­out isn’t go­ing to cut it with in­vestors.

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.


Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.

J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

In a boost to Rit­ux­an fran­chise, Roche nabs quick ap­proval for po­latuzum­ab ve­dotin

Roche’s lat­est an­ti­body-drug con­ju­gate has crossed the FDA fin­ish line, gain­ing an ac­cel­er­at­ed ap­proval a full two months ahead of sched­ule.

Po­livy, or po­latuzum­ab ve­dotin, is a first-in-class drug tar­get­ing CD79b — a pro­tein promi­nent in B-cell non-Hodgkin lym­phoma. It will now be mar­ket­ed for dif­fuse large B-cell lym­phoma as part of a reg­i­men that al­so in­cludes the chemother­a­py ben­damus­tine and a ver­sion of rit­ux­imab (Rit­ux­an).

An in­censed Cat­a­lyst Phar­ma sues the FDA, ac­cus­ing agency of bow­ing to po­lit­i­cal pres­sure and break­ing fed­er­al law

Af­ter hint­ing it was ex­plor­ing the le­gal­i­ty of the FDA’s ap­proval of a ri­val drug from fam­i­ly-run com­pa­ny Ja­cobus Phar­ma­ceu­ti­cals, Cat­a­lyst Phar­ma­ceu­ti­cals on Wednes­day filed a law­suit against the health reg­u­la­tor — ef­fec­tive­ly ac­cus­ing the agency of bow­ing to po­lit­i­cal pres­sure sur­round­ing sky­rock­et­ing drug prices.

Be­fore Cat­a­lyst’s Fir­dapse (which car­ries an av­er­age an­nu­al list price of $375,000) was sanc­tioned for use in Lam­bert-Eaton myas­thenic syn­drome (LEMS) by the FDA, hun­dreds of pa­tients had been able to ac­cess a sim­i­lar drug from com­pound­ing phar­ma­cies for a frac­tion of the cost, or Ja­cobus’ for free, as part of an FDA-rat­i­fied com­pas­sion­ate use pro­gram. But the ap­proval of the Cat­a­lyst drug — ac­com­pa­nied by mar­ket ex­clu­siv­i­ty span­ning sev­en years — ef­fec­tive­ly pre­clud­ed Ja­cobus and com­pound­ing phar­ma­cies from sell­ing their ver­sions.

Plagued by de­lays, As­traZeneca HQ costs soar to £750M as it edges to­ward 2020 com­ple­tion

In the lat­est up­date on As­traZeneca’s de­lay-prone HQ project, the phar­ma gi­ant re­vealed that the cost of con­struc­tion has swelled to £750 mil­lion ($956 mil­lion) — more than dou­ble the orig­i­nal es­ti­mate in 2013.

The move-in date is still in 2020, a spokesper­son con­firmed, af­ter As­traZeneca pushed pro­ject­ed com­ple­tion from 2016 to 2017, and then to the spring of 2019. While the ini­tial plan called for a £330 mil­lion (then $500 mil­lion) in­vest­ment, the cost bal­looned to £500 mil­lion ($650 mil­lion), and more in the most re­cent up­date.