Bay­er steps up with $1.55B deal to take a lead role in com­mer­cial­iz­ing Loxo’s can­cer drugs

Bay­er is buy­ing in­to the close­ly-watched piv­otal can­cer pro­gram un­der­way at Loxo On­col­o­gy $LOXO. And they are pay­ing big to part­ner on Loxo’s pipeline of ge­net­i­cal­ly de­fined can­cer ther­a­pies.

Bag­ging com­mer­cial­iza­tion rights on larotrec­tinib, its fol­low-up drug LOXO-195 and the whole pipeline at Loxo, Bay­er is hand­ing over a $400 mil­lion up­front, $450 mil­lion in mile­stones for the de­vel­op­ment and first sale of larotrec­tinib, with an­oth­er $200 mil­lion on the ta­ble for LOXO-195. There’s al­so $500 mil­lion on the books for com­mer­cial goals.

Both of the lead drugs tar­get rare cas­es of TRK fu­sion, but LOXO-195 — which has be­gun to pro­duce the first set of pos­i­tive da­ta — is for pa­tients who de­vel­op re­sis­tance to a TRK in­hibitor. Rather than de­vel­op a drug for a spe­cif­ic or­gan type, Loxo’s drugs are de­signed to be used wher­ev­er ge­net­i­cal­ly de­fined cas­es de­vel­op.

Loxo and Bay­er will split the costs and the prof­its in the US in the deal, with Bay­er tak­ing the lead role on the reg­u­la­to­ry side out­side of the US.

Loxo’s shares, though, have been swelling as a large group of in­vestors be­gan bet­ting on a buy­out, with a big up­side for share­hold­ers. Now that Loxo is sig­nal­ing that it’s go­ing com­mer­cial with a part­ner, though, its shares re­act­ed by drop­ping 8%.

Robert La­Caze

For a small com­pa­ny with just a few dozen staffers, Loxo has enor­mous am­bi­tions that in­clude shoot­ing at some ground­break­ing ad­vances in drug de­vel­op­ment. At AS­CO last sum­mer, the biotech boast­ed a 76% tu­mor re­sponse rate for larotrec­tinib among pa­tients with mul­ti­tude of dif­fer­ent tu­mor types. Un­like a typ­i­cal can­cer drug fo­cused on the anato­my, Loxo is go­ing af­ter a bio­mark­er — tropomyosin re­cep­tor ki­nase (TRK) fu­sions — and at AS­CO it cob­bled to­geth­er re­sponse da­ta from three ear­ly-stage tri­als.

Like oth­ers in the field, Loxo — helmed by CEO Josh Bilenker — has been able to vault from ear­ly to late-stage de­vel­op­ment in a blur of re­cent ac­tiv­i­ty.

Loxo has been say­ing for months now that it’s plan­ning to file for an ap­proval on larotrec­tinib ei­ther late this year or ear­ly next. In a re­cent call with an­a­lysts, Chief Busi­ness Of­fi­cer Ja­cob van Naar­den said:

In­ter­nal­ly, we’re prepar­ing for a mid-2018 ap­proval and launch. But again, that’s more from a pre­pared­ness per­spec­tive not a sort of guid­ance of when we think the drug will ac­tu­al­ly get ap­proved.

Bay­er, mean­while, has had mixed re­sults this year. Look­ing to as­sure the mar­kets that its phar­ma busi­ness wouldn’t lan­guish as it pur­sued Mon­san­to, Bay­er had pre­dict­ed that its pipeline in­clud­ed 6 drugs — veri­ciguat, finerenone, vi­laprisan, BAY-1841788, the can­cer drug ane­tum­ab rav­tan­sine and co­pan­lis­ib — with 6 bil­lion eu­ros in peak sales.

Ane­tum­ab was Ex­hib­it A in that case, but it re­cent­ly failed a Phase II study. Co­pan­lis­ib, though, was ap­proved.

Bay­er’s will­ing­ness to pay big to jump in­to a lead role here un­der­scores just how high val­u­a­tions are run­ning and al­so how hot the whole on­col­o­gy field is right now.

“We see great po­ten­tial in larotrec­tinib and more­over the fol­low-on com­pound LOXO-195 which may pro­vide ad­di­tion­al ben­e­fit for pa­tients who might progress on an ini­tial TRK in­hi­bi­tion ther­a­py. These agents have the po­ten­tial to ful­fill the promise of pre­ci­sion med­i­cine, where tu­mor ge­net­ics rather than tu­mor site of ori­gin de­fine the treat­ment ap­proach for pa­tients”, said Robert La­Caze, ex­ec­u­tive vice pres­i­dent and head of the On­col­o­gy Strate­gic Busi­ness Unit at Bay­er.

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.

Ted Love. HAVERFORD COLLEGE

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.