6 months af­ter ar­riv­ing at Sanofi R&D, John Reed gam­bles $125M on De­nali’s RIPK1 work

Sanofi’s new R&D chief, John Reed, is on the march. 

New­ly ar­rived from Roche, Reed is hand­ing over $125 mil­lion in cash to part­ner with De­nali $DNLI on a RIPK1 ap­proach to tamp­ing down in­flam­ma­tion. And in the deal — which in­cludes more than a bil­lion dol­lars in mile­stones — the French phar­ma gi­ant is grab­bing sys­temic in­flam­ma­to­ry dis­eases while the De­nali team con­tin­ues to lead the charge on the blood-brain bar­ri­er and neu­ro dis­eases.

Alex Schuth

De­nali dived in­to RIP1 a lit­tle more than 2 years ago, buy­ing out In­cro and bag­ging one of their top drugs — which ini­tial­ly came out of Har­vard — for the pipeline. That ap­proach to in­flam­ma­tion, pro­vid­ed they could get it in­to the brain prop­er­ly, has po­ten­tial in ALS, mul­ti­ple scle­ro­sis and Alzheimer’s. And it’s pay­ing some quick div­i­dends af­ter a key play­er took care­ful no­tice of their work.

“John Reed was a cham­pi­on of this deal,” De­nali chief op­er­at­ing of­fi­cer Alex Schuth tells me, cit­ing some of the team play­ers around Reed who helped close the deal.

Reed is com­mit­ting his re­search group to the RIP1 tar­gets out­side the brain. Sanofi will take over the de­vel­op­ment work of DNL758 for tar­gets such as rheuma­toid arthri­tis and pso­ri­a­sis while fund­ing the Phase Ib/II costs for DNL747 for ALS, MS and oth­er con­di­tions — oth­er than Alzheimer’s, where De­nali re­tains re­spon­si­bil­i­ty for costs. Sanofi then will cov­er 70% of the costs in the piv­otal neu­ro work.

The com­pa­nies plan to share prof­its and loss­es in the US and Chi­na on 747, while Sanofi will pay roy­al­ties on 747 from the rest of the world and on all 758 sales. Sanofi al­so gets rights to pre­clin­i­cal RIPK1 in­hibitor mol­e­cules.

This is one of the first new deals to be struck by John Reed since he made the leap to Sanofi 6 months ago, with Elias Zer­houni on the way out. A deeply re­spect­ed sci­en­tist, Reed made lit­tle pub­lic progress while he was run­ning the show at pRED based in Basel.

Sanofi, mean­while, has earned a poor rep­u­ta­tion for in-house in­no­va­tion. But it has a great rep for col­lab­o­ra­tions, with a high-pro­file al­liance with Re­gen­eron that was re­cent­ly down­grad­ed at the gi­ant phar­ma com­pa­ny.

Steve Krognes

De­nali has man­aged to en­joy con­sid­er­able cred­i­bil­i­ty while walk­ing a mine field of risk. The ex­ec­u­tive team out of Genen­tech has some of the best re­sumes in the field, and their tar­get­ed, ge­net­ics-based ap­proach to CNS has won sig­nif­i­cant back­ing as they built the over­all staff to 175, with a new HQ un­der con­struc­tion right next to their cur­rent site in South San Fran­cis­co’s Oys­ter Point.

Steve Krognes, the CFO at De­nali, is hap­py to talk about the staffing (grow­ing), the new HQ (ready for move-in in March) and the mon­ey re­serves (sig­nif­i­cant). De­nali struck an­oth­er ma­jor col­lab­o­ra­tion with Take­da at the be­gin­ning of this year for Alzheimer’s and near that de­liv­ered $155 mil­lion in cash and an eq­ui­ty stake.

But he and Schuth are al­so a lit­tle low key about some of the timeta­bles and the ex­act chem­i­cal prop­er­ties that make these drugs best-in-class con­tenders.

We can find out more about that as da­ta are as­sem­bled.

They’re not alone in RIP1, by any means. Just a cou­ple of weeks ago Hal Bar­ron sin­gled out a mid-stage pro­gram at GSK, which he char­ac­ter­ized as a high-risk, high-re­ward drug that might need some work ahead of any piv­otal test.

Im­age: John Reed. 

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.

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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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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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.

Fresh analy­sis spot­lights car­dio ben­e­fit of J&J's In­vokana in di­a­betes pa­tients with­out his­to­ry of CV dis­ease

In­vokana sales may be mut­ed, but the di­a­betes drug is set to get some love af­ter its mak­er J&J un­veiled da­ta at the Amer­i­can Di­a­betes As­so­ci­a­tion meet­ing on Tues­day sug­gest­ing the med­i­cine can con­fer a car­dio­vas­cu­lar ben­e­fit in pa­tients who do not have pre­ex­ist­ing CV dis­ease.

Back in April, J&J had re­port­ed that in the late-stage CRE­DENCE study, the SGLT2 drug scored a 30% re­duc­tion in the risk of a com­pos­ite of ail­ments: a pro­gres­sion to the dou­bling of serum cre­a­ti­nine, end-stage kid­ney dis­ease and re­nal or car­dio­vas­cu­lar death. In terms of sec­ondary end­points, the drug was al­so found be heart-pro­tec­tive: low­er­ing the risk of CV death and hos­pi­tal­iza­tion for heart fail­ure by 31%, as well as ma­jor ad­verse CV events by 20%. In March, the com­pa­ny sub­mit­ted an ap­pli­ca­tion to ex­pand In­vokana’s la­bel to re­flect its im­pact on chron­ic kid­ney dis­ease.

Sil­i­con Val­ley's most an­tic­i­pat­ed slide deck just dropped. What does it mean for bio­phar­ma's dig­i­tal teams?

These aren’t the typ­i­cal slides you’d see at End­points — no mol­e­cules, clin­i­cal pro­grams, or p-val­ues. In­stead, we’ll talk dig­i­tal and in­ter­net trends, fac­tors that elite glob­al brands — re­gard­less of in­dus­try — must first mea­sure and un­der­stand be­fore de­ploy­ing prod­ucts in­to the world. That’s a con­cept that most of our Big Phar­ma au­di­ence is in tune with. Dig­i­tal aware­ness is key to suc­cess in the dis­cov­ery, de­vel­op­ment, and mar­ket­ing of new bio­phar­ma­ceu­ti­cals, and most of the ma­jors now have a chief dig­i­tal of­fi­cer: No­var­tis, Sanofi, and Pfiz­er, just to name a few.