Bris­tol-My­ers’ tar­nished check­point star Op­di­vo beats out Yer­voy in sur­prise PhI­II

Bris­tol-My­ers got a much-need­ed boost with the ear­li­er-than-ex­pect­ed news that Op­di­vo beat out Yer­voy in a Phase III study fo­cused on a par­tic­u­lar niche for ad­ju­vant melanoma ther­a­py. And an an­a­lyst who’s been fol­low­ing the da­ta says it could be worth a bil­lion dol­lars in added an­nu­al sales.

The big biotech says an in­ter­im analy­sis of Check­mate-238 pro­vid­ed re­searchers with proof that the PD-1 drug out­per­formed Yer­voy, Bris­tol-My­ers’ CT­LA-4 drug, among ad­vanced Stage II­Ib or IV pa­tients, cut­ting the re­cur­rence rate for those who have un­der­gone surgery. There are no bot­tom line num­bers in the state­ment, but Bris­tol-My­ers says they’ll be able to re­lease da­ta at an up­com­ing con­fer­ence to show that Op­di­vo pro­vid­ed a sig­nif­i­cant­ly low­er risk of dis­ease re­cur­rence.

Sea­mus Fer­nan­dez notes that the re­sults are like­ly to can­ni­bal­ize Bris­tol’s Yer­voy rev­enue, but will like­ly de­liv­er a $1 bil­lion boost to Op­di­vo as physi­cians steer away from the high­er dos­es of high­ly tox­ic Yer­voy. He not­ed:

This comes as a sur­prise, as top-line da­ta were not ex­pect­ed un­til the fi­nal read­out in 2H:18. While there were no de­tails in the press re­lease re­gard­ing the mag­ni­tude of ben­e­fit for Op­di­vo, we would ex­pect it to be­come the stan­dard of care in high-risk pa­tients fol­low­ing sur­gi­cal re­sec­tion giv­en its su­pe­ri­or safe­ty and tol­er­a­bil­i­ty pro­file rel­a­tive to Yer­voy. We es­ti­mate the ad­ju­vant melanoma mar­ket will ex­pand PD1 sales by ap­prox­i­mate­ly $3B glob­al­ly. Al­though this like­ly will can­ni­bal­ize sales of Yer­voy in the set­ting (we es­ti­mate cur­rent ad­ju­vant Yer­voy sales at $300-400M), the ex­pan­sion of the mar­ket should add ap­prox­i­mate­ly $1B to BMY’s net im­muno-on­col­o­gy (IO) sales de­spite as­sumed com­pe­ti­tion from MRK’s (MP) Keytru­da (pem­brolizum­ab; an­ti-PD-1).

Vic­ki Good­man

Op­di­vo’s rocky road at Bris­tol has led to end­less spec­u­la­tion that the com­pa­ny could find it­self on the auc­tion block be­fore it gets a chance to re­or­ga­nize in the clin­ic and come back in its head-to-head show­down with Mer­ck’s Keytru­da. But it is al­so rack­ing up bil­lions in an­nu­al sales of Op­di­vo, with a slate of new tri­als un­der­way.

“These topline re­sults sup­port the po­ten­tial promise of Op­di­vo as a treat­ment op­tion for pa­tients with high-risk sur­gi­cal­ly re­sect­ed melanoma. There re­mains an un­met need for ad­di­tion­al op­tions as the ma­jor­i­ty of stage III and re­sect­ed stage IV high-risk melanoma pa­tients ex­pe­ri­ence dis­ease re­cur­rence af­ter surgery,” said Vic­ki Good­man, de­vel­op­ment lead, melanoma and gen­i­touri­nary can­cers, Bris­tol-My­ers Squibb. “We are com­mit­ted to re­search­ing ther­a­pies that may bet­ter meet the needs of this pa­tient pop­u­la­tion and look for­ward to shar­ing these da­ta with health au­thor­i­ties soon.”

Jef­frey We­ber

Physi­cians in the field, in­clud­ing the high pro­file Jef­frey We­ber at NYU Lan­gone, have been wait­ing to see how this one will shake out. And they’re get­ting the read­out a year ahead of sched­ule. In a pan­el chat with ex­perts in the field in the spring of 2016, he not­ed:

On the ba­sis of my own ex­pe­ri­ence with both drugs in pi­lot ad­ju­vant tri­als, I have a sus­pi­cion that nivolum­ab is go­ing to look bet­ter than ip­il­i­mum­ab. And the next fron­tier is what we’ve al­ready pi­lot­ed when I was at Mof­fitt and we’ll con­tin­ue at NYU, which is com­bi­na­tion ad­ju­vant ther­a­py. But be­cause of the tox­i­c­i­ty, we flipped the dos­es giv­ing one of ip­il­i­mum­ab and three of nivolum­ab, which is very well-tol­er­at­ed with a pret­ty good track record, ad­mit­ted­ly, in a small study. So, I think that we’ve gone from in­ter­fer­on, we’ll go to ip­il­i­mum­ab, we’ll go to nivolum­ab, and even­tu­al­ly end up at ip­il­i­mum­ab plus nivolum­ab, over the next five years, which brings us to where we’re go­ing in metasta­t­ic treat­ment. I think we’re go­ing to see triple com­bi­na­tions. On the one hand, it’s sci­en­tif­i­cal­ly fas­ci­nat­ing, ex­treme­ly com­plex with para­dox­i­cal­ly a bar that’s now so high, it’s go­ing to be very dif­fi­cult to get com­bi­na­tions ap­proved. You’re go­ing to need to see ma­jor in­cre­men­tal ad­van­tages, which I think you prob­a­bly will see with some of the drugs my col­leagues have men­tioned. But they’re al­so go­ing to be very ex­pen­sive, so phar­ma­coeco­nom­ics is al­so go­ing to play a huge role in what we do. Right now, I would es­ti­mate that the cost of ip­il­i­mum­ab plus nivolum­ab ther­a­py for a year is about $250,000. So, I would ask where does this all end?

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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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.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.