Mer­ck’s glo­ri­ous vic­to­ry in lung can­cer marks a Russ­ian win­ter for Bris­tol-My­ers

Sun­day was check­point in­hibitor day at ES­MO, with the three big play­ers now in the mar­ket out­lin­ing how they’re lin­ing up in the block­buster field of lung can­cer ther­a­py. Mer­ck was left in the en­vi­able po­si­tion of dri­ving home some im­pres­sive re­sults from its clin­i­cal study while Bris­tol-My­ers Squibb had to try to put its mis­er­able out­comes in a some­what pos­i­tive con­text and a de­ter­mined Roche/Genen­tech team an­gled in on its niche.

As­traZeneca CEO Pas­cal So­ri­ot, mean­while, had to stand on the side­lines de­vout­ly wish­ing he was in the game of block­busters.

Bris­tol-My­ers Squibb $BMY made a Napoleon­ic mis­cal­cu­la­tion when it de­cid­ed to see if Op­di­vo could beat chemother­a­py as a front­line treat­ment for a broad pa­tient pop­u­la­tion suf­fer­ing from non-small cell lung can­cer. We al­ready knew from the top-line an­nounce­ment that the tri­al failed — trig­ger­ing some­thing of a Russ­ian win­ter for Bris­tol stock. Now we know that it failed re­al­ly, re­al­ly bad­ly, and in­vestors weren’t hap­py, send­ing its shares down sharply Mon­day morn­ing.

Low­er­ing the bar to pa­tients with 5% or more of their can­cer cells ex­press­ing PD-L1, Bris­tol’s Op­di­vo de­layed tu­mor pro­gres­sion 4.2 months. Chemo? 5.9 months.

“We thought Op­di­vo could beat chemother­a­py, and we have an­swered the ques­tion — for the broad pop­u­la­tion it is not enough,” Fouad Namouni, on­col­o­gy de­vel­op­ment head at Bris­tol-My­ers, told David Crow at the Fi­nan­cial Times.

That’s ac­tu­al­ly a very valu­able point and in the sci­ence world it would and should be ap­plaud­ed. But even in sub­group analy­ses, Bris­tol’s in­ves­ti­ga­tors could find new ev­i­dence of suc­cess. To in­vestors ex­pect­ing Bris­tol-My­ers to con­tin­ue their dom­i­na­tion of the sec­tor, though, it all looks like an epic mis­cal­cu­la­tion and set­back with­out a sin­gle re­deem­ing fea­ture.

Mer­ck R&D chief Roger Perl­mut­ter $MRK made no such mis­take in mov­ing on the front­line mar­ket front. Play­ing Welling­ton in this R&D Wa­ter­loo, Perl­mut­ter fo­cused on pa­tients with a 50%-plus PD-L1 ex­pres­sion rate and round­ed up a 50% re­duc­tion in the risk of dis­ease pro­gres­sion and 40% plunge in risk of death com­pared to chemo in pre­vi­ous­ly un­treat­ed pa­tients.

This is what a new stan­dard of care for a seg­ment of front-line lung can­cer cas­es looks like. This drug is al­ready be­ing sold and you can bet that the phar­ma gi­ant will move as fast as it can to cap­i­tal­ize on this mar­ket. That’s a glo­ri­ous vic­to­ry by any bio­phar­ma stan­dard.

Over re­cent months Bris­tol-My­ers stock has re­treat­ed sig­nif­i­cant­ly while Mer­ck has ad­vanced. That’s how you can score the war. And Mon­day morn­ing Mer­ck stock bub­bled up an­oth­er 3% while Bris­tol-My­ers shares plunged 8%.

But Mer­ck won’t re­main un­chal­lenged. Steal­ing some of the thun­der at ES­MO is Genen­tech’s Tecen­triq. Roche’s big check­point, the third to be ap­proved and start spread­ing its wings, achieved a sol­id suc­cess in sec­ond-line NSCLC. Their 13.8 month me­di­an sur­vival rate com­pared fa­vor­ably with the 9.6 months record­ed for the chemo arm.

Dan Chen, who’s head­ed up can­cer im­munother­a­py de­vel­op­ment for Genen­tech, told Fier­cePhar­ma’s Car­ly Helfand that the da­ta were “es­sen­tial­ly un­prece­dent­ed.” But when you sin­gled out the high PD-L1 ex­pressers, the da­ta weighed even more heav­i­ly on Tecen­triq’s side: 20.5 months me­di­an sur­vival com­pared to 8.9 months in the chemo arm.

Now Roche $ROG can break out from its unique blad­der can­cer ap­proval and start to tear up the sec­ond-line lung can­cer mar­ket, look­ing for an ad­van­tage with all the high PD-L1 ex­pressers. A front­line pitch can’t be far off.

While Mer­ck, Bris­tol-My­ers and Roche are divvy­ing up the mar­ket, As­traZeneca is still side­lined af­ter its ef­forts fell well be­hind its ri­vals. But who was that stand­ing on the edge of the bat­tle­field?

“Sud­den­ly, this tri­al news opens quite some op­por­tu­ni­ties for us, in both monother­a­py and com­bi­na­tion ther­a­py,” a sun­ny As­traZeneca Chief Ex­ec­u­tive Pas­cal So­ri­ot told Reuters’ Ben Hirschler, siz­ing up the fast-chang­ing lung can­cer mar­ket.

As­traZeneca’s check­point pro­gram $AZN has been a lag­gard and will ar­rive to the fray very late. For So­ri­ot, though, it’s all char­ac­ter­ized as an ad­van­tage; a chance to see how oth­ers have done their stud­ies so they can match the best work. But af­ter a se­ries of clin­i­cal set­backs, As­traZeneca looks like its re­ced­ing from So­ri­ot’s promis­es of great ad­vances on the rev­enue front, 4 years af­ter he got the top job. He needs a piece of the check­point mar­ket—and fast.

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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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.

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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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.

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.

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.

Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”