Phar­ma 'greed' emerges as a po­tent po­lit­i­cal is­sue in a rau­cous elec­tion year

Phar­ma ex­ecs aren’t the most pop­u­lar peo­ple in the US these days, par­tic­u­lar­ly when they keep hik­ing the price of their drugs. And a sen­ate cam­paign in New Jer­sey is dri­ving that point home — right to the hilt.

Over the last few days Bob Hug­in’s po­lit­i­cal op­po­nents fight­ing the Re­pub­li­can ex-Cel­gene CEO’s cam­paign in New Jer­sey have been run­ning a bit­ter ad spot fea­tur­ing can­cer sur­vivor Pam Holt. Holt notes that Cel­gene’s Revlim­id costs a dol­lar a pill to make, and Cel­gene charges $600 for it, af­ter more than dou­bling what it orig­i­nal­ly cost when it hit the mar­ket.

“He was the CEO of the drug com­pa­ny that dou­bled the price on us, while he made $100 mil­lion,” she tells the cam­era. “Now he wants to be your sen­a­tor. But I’ll al­ways know him as the guy who made a killing off can­cer pa­tients like me.”

Cel­gene has al­ready in­di­rect­ly come in for some point­ed crit­i­cism from HHS sec­re­tary Alex Azar af­ter push­ing the price 20% last year. And now the com­pa­ny has re­port­ed­ly fol­lowed up with a 5% hike, with plans to leave it at that.

That’s prob­a­bly not great tim­ing from Hug­in’s per­spec­tive. Bob Menen­dez’s cam­paign float­ed a web­site called Health­News­NJ to paint him as a greedy phar­ma ex­ec. And the Menen­dez cam­paign chief has tak­en to call­ing Hug­in’s pay at Cel­gene “blood mon­ey.”

Cel­gene’s heavy re­liance on an ever-ris­ing price for Revlim­id to swell rev­enue is a stan­dard strat­e­gy at the big bio­phar­ma com­pa­nies. But these at­tack ads show that it has be­come a po­lit­i­cal hot pota­to, fu­el­ing a back­lash with broad im­pli­ca­tions for all the big play­ers. 

Just last week, af­ter Don­ald Trump promised we’d all be see­ing falling prices, Pfiz­er went ahead — like oth­ers — with price hikes on dozens of its port­fo­lio prod­ucts. Then the phone rang. 

The pres­i­dent called Pfiz­er CEO Ian Read per­son­al­ly to per­suade him to de­lay a big round of price hikes on their port­fo­lio, and got him to slam the brakes on the move — at least for now. 

Will oth­ers fol­low, or risk draw­ing the same un­wel­come spot­light?

Hug­in left his po­si­tion as Cel­gene chair­man to run for the Sen­ate, and there’s noth­ing he can do about the price of Revlim­id now. But he is push­ing back against the at­tack ad. His cam­paign just post­ed a new 30-sec­ond spot fea­tur­ing the fa­ther of an­oth­er can­cer pa­tient who says the phar­ma ex­ec pro­vid­ed Revlim­id when his in­sur­ance com­pa­ny wouldn’t cov­er it for his son.

“It’s not the drugs,” he says. “It’s not the prof­its. It’s a very per­son­al thing for Bob Hug­in.”


Im­age: Bob Hug­in at a pri­ma­ry elec­tion, June 5, 2018. AP IM­AGES

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.