Bruised by a pun­ish­ing Op­di­vo fail­ure, Bris­tol-My­ers looks to shake up the busi­ness, ac­cel­er­ate R&D

Gio­van­ni Caforio, Bris­tol-My­ers Squibb CEO

Fresh off one of the biggest clin­i­cal tri­al set­backs of the year, Bris­tol-My­ers Squibb $BMY is plan­ning to re­group and ac­cel­er­ate on the R&D side as part of a broad re­or­ga­ni­za­tion, shift­ing more mon­ey in­to re­search af­ter hunt­ing out sav­ings in the rest of the busi­ness.

The de­tails are sparse, but the com­pa­ny says in its new­ly re­leased Q3 up­date that it plans to cre­ate a “com­pet­i­tive and more ag­ile R&D or­ga­ni­za­tion that can ac­cel­er­ate the pipeline, stream­lined op­er­a­tions and re­aligned man­u­fac­tur­ing ca­pa­bil­i­ties that broad­en bi­o­log­ics ca­pa­bil­i­ties to re­flect cur­rent and fu­ture port­fo­lio. The new op­er­at­ing mod­el will en­able the com­pa­ny to de­liv­er the strate­gic, fi­nan­cial and op­er­a­tional flex­i­bil­i­ty nec­es­sary to in­vest in the high­est pri­or­i­ties across the com­pa­ny.”

The ex­ec­u­tive crew stayed fo­cused on broad gen­er­al­i­ties in the call with an­a­lysts Thurs­day morn­ing. CEO Gio­van­ni Caforio em­pha­sized that the com­pa­ny will “con­tin­u­ing to al­lo­cate re­sources dri­ven by op­por­tu­ni­ties we see in the port­fo­lio.” Over the next three to five years, he ex­pects that the op­por­tu­ni­ties for rev­enue growth with stay fo­cused pri­mar­i­ly on Op­di­vo, Yer­voy and Eliquis.

“At same time,” he adds, “we’re ad­vanc­ing the ear­ly pipeline,” ready to back pro­grams that emerge as high po­ten­tial per­form­ers. Bris­tol plans to in­crease R&D spend­ing next year, fo­cus­ing even more on its core ar­eas, while squeez­ing op­er­at­ing ex­pens­es, in­fra­struc­ture and man­u­fac­tur­ing costs wher­ev­er pos­si­ble.

The R&D spot­light now shifts to Check­mate-227, test­ing a com­bi­na­tion of Op­di­vo and Yer­voy. Im­muno-on­col­o­gy chief Fouad Namouni says that the com­pa­ny has learned from the Check­mate-026 set­back, dou­bling the num­ber of pa­tients it’s re­cruit­ing for ‘227 in or­der to avoid a re­peat of what Bris­tol views was a poor se­lec­tion of pa­tients test­ed in ‘026.

Bris­tol-My­ers suf­fered a damn­ing Phase III fail­ure with their flag­ship drug, the check­point in­hibitor Op­di­vo. Eas­i­ly the dom­i­nant check­point on the mar­ket, Op­di­vo flunked a late-stage tri­al that tried and failed to demon­strate an ad­van­tage for a broad pop­u­la­tion of non-small cell lung can­cer pa­tients as a front­line ther­a­py. Even more damn­ing, the sub­pop­u­la­tion break­down in the study — re­viewed at ES­MO — looked bad for Op­di­vo.

Mer­ck, which had had to ac­cept a run­ner-up po­si­tion in the mar­ket, was able to quick­ly leapfrog Bris­tol-My­ers by demon­strat­ing Keytru­da was ef­fec­tive among high PD-L1 ex­pressers, and the FDA swift­ly fol­lowed up with a pi­o­neer­ing front­line ap­proval in that key group.

What re­mains to be seen is how Bris­tol-My­ers plans to make its R&D group “more ag­ile.” The com­pa­ny has been pour­ing mon­ey in­to its im­muno-on­col­o­gy work, hir­ing new staffers and adding a cam­pus in Cal­i­for­nia.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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UP­DAT­ED: Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

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Why wait? Cel­gene re­struc­tures a big Jounce pact — ze­ro­ing in on new I/O path­way with $530M deal and bump­ing ICOS

Celgene’s business team isn’t waiting for the big merger with Bristol-Myers Squibb to go through before syncing its strategy with the new mother ship.

Tuesday evening the big biotech unveiled a $530 million deal — $50 million in upfront cash — to amend their alliance with Jounce Therapeutics $JNCE to gain worldwide rights to JTX-8064, an antibody that targets the LILRB2 receptor on macrophages. Their old, $2.6 billion deal is being scrapped, leaving Jounce with a pipeline that includes the lead drug, the ICOS-targeting vopratelimab.

PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

UP­DAT­ED: My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche cuts loose Tam­i­flu OTC rights, hand­ing Sanofi the keys as the phar­ma gi­ant dou­bles down on Xofluza

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.