Is a se­vere­ly dam­aged Bio­gen look­ing to shed its ties to a con­tro­ver­sial de­vel­op­ment part­ner?

Af­ter tak­ing it on the chin through­out Thurs­day and Fri­day for its ques­tion­able strat­e­gy of stick­ing with the amy­loid be­ta the­o­ry on Alzheimer’s — topped by the news that its part­ner Ei­sai had picked one of the worst mo­ments pos­si­ble to launch a new Phase III tri­al of their oth­er Alzheimer’s drug BAN2401 — Bio­gen end­ed the week with a state­ment that stopped far short of a ring­ing en­dorse­ment of the move by their col­lab­o­ra­tors.

Here’s what they sent me Sat­ur­day morn­ing:

“We can con­firm that our col­lab­o­ra­tion part­ner, Ei­sai, has is­sued a news re­lease to an­nounce the start of a Phase III with BAN2401. We are work­ing with Ei­sai to eval­u­ate the po­ten­tial next steps for Bio­gen. We are not com­ment­ing fur­ther. Please di­rect your ques­tions to Ei­sai.”

Their oth­er part­nered Alzheimer’s drug is the BACE pro­gram for elen­be­ce­s­tat, which fol­lows in the wake of mas­sive set­backs in the field that in­di­cate turn­ing down the flow of amy­loid be­ta doesn’t work in deal­ing with the dis­ease.

Bio­gen’s stock $BI­IB end­ed the week down more than $100 a share at $216.71, a dis­as­trous 32% plunge on a Phase III fail­ure for ad­u­canum­ab that is lead­ing to un­end­ing spec­u­la­tion about whether the com­pa­ny can work it­self out of the fix it’s in or stands to get bought out it­self.

“(T)his is ab­solute mad­ness,” summed up Baird’s Bri­an Sko­r­ney as he looked over the lat­est de­vel­op­ments.

The ques­tion now is whether Ei­sai will be part of Bio­gen’s fu­ture. That de­ci­sion will rest in large part on Bio­gen CEO Michel Vounatsos, who staked his ca­reer on the now failed ad­u­canum­ab back in the fall of 2017. The CEO re­struc­tured his al­liance with Ei­sai and bought up an in­creased roy­al­ty share in ad­u­canum­ab in a slate of deals that amount­ed to $500 mil­lion in added in­vest­ments.

That big buy-in has come back to haunt him now.

Bio­gen rocked the bio­phar­ma world with the news that it scrapped the late-stage stud­ies for ad­u­canum­ab af­ter con­clud­ing the tri­als were head­ed straight to the rocks — the lat­est in a long string of de­ci­sive fail­ures in the field that has left a line­up of ob­servers ready to con­clude that any new in­vest­ments in the amy­loid be­ta field would be fool­hardy. They’ve al­ready been se­vere­ly crit­i­cized for their work on BAN2401, part­nered with Ei­sai, which be­gan the new Phase III study on Fri­day.

I asked Ei­sai whether Bio­gen had been in touch to re­view its con­tin­u­ing in­volve­ment, which would now ap­pear to be in doubt. A spokesper­son did not an­swer that query,

The two com­pa­nies were hit by a con­tro­ver­sy on BAN2401, you may re­call, af­ter Ei­sai ex­ecs tout­ed ef­fi­ca­cy da­ta and then re­vealed that re­searchers had pulled high-risk pa­tients out of the tri­al, per­haps warp­ing any re­sults.

BAN2401 re­mains one of a hand­ful of drugs still in the clin­ic that is built on the idea that re­duc­ing tox­ic lev­els of amy­loid be­ta can bend the course of the dis­ease. That’s nev­er hap­pened yet, though, with bil­lions spent on the no­tion while Eli Lil­ly, As­traZeneca, Mer­ck and Roche have all con­ced­ed ma­jor late-stage flops in the last year.

Be­ing the last de­fend­er on that hill won’t win any hearts and minds on Wall Street, and Bio­gen needs all the sup­port it can get.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

Sanofi aligns it­self with Google to stream­line drug de­vel­op­ment

Tech­nol­o­gy is bleed­ing in­to health­care, and big phar­ma is rid­ing the wave. Sanofi $SNY ap­point­ed its first chief dig­i­tal of­fi­cer this Feb­ru­ary, fol­low­ing the foot­steps of its peers. By May, the French drug­mak­er and some of its big phar­ma com­pa­tri­ots joined forces with Google par­ent Al­pha­bet’s Ver­i­ly unit to aug­ment clin­i­cal tri­al re­search. On Tues­day, the Parisian com­pa­ny tied up with Google to ac­cess its cloud com­put­ing and ar­ti­fi­cial in­tel­li­gence tech to spur the de­vel­op­ment of new ther­a­pies.

Right back at you, Pfiz­er: BeiGene and a Pfiz­er spin­out launch a new­co to de­vel­op a MEK/BRAF in­hibitor that could ri­val $11.4B com­bo

A day af­ter Pfiz­er bought Ar­ray and its ap­proved can­cer com­bo, BeiGene and Pfiz­er spin­out Spring­Works have part­nered in launch­ing a new biotech that has an eye on the very same mar­ket the phar­ma gi­ant just paid bil­lions for. And they’re plan­ning on us­ing an ex-Pfiz­er drug to do it.

In a nut­shell, Chi­na’s BeiGene is toss­ing in a pre­clin­i­cal BRAF in­hibitor — BGB-3245, which cov­ers both V600 and non-V600 BRAF mu­ta­tions — for a big stake in a new, joint­ly con­trolled biotech called Map­Kure with Bain-backed Spring­Works.

UP­DAT­ED: Roche fields first ap­proval for Ro­z­lytrek in the run-up to a show­down with Bay­er, Pfiz­er

While it’s wait­ing to hear back from FDA reg­u­la­tors, Roche is be­gin­ning the vic­to­ry lap for en­trec­tinib in Japan.

Roche is giv­ing Bay­er a run for their mon­ey with this tu­mor-ag­nos­tic drug, which tar­gets NTRK gene fu­sions. Now dubbed Ro­z­lytrek, it’s sanc­tioned to treat adult and pe­di­atric pa­tients in Japan with neu­rotroph­ic ty­ro­sine re­cep­tor ki­nase fu­sion-pos­i­tive, ad­vanced re­cur­rent sol­id tu­mors.