The longterm im­pli­ca­tions of the Trump Bump; Let’s try again on drug pric­ing

End­points as­sess­es the big bio­phar­ma R&D sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.

Bio­phar­ma in­vestors fall in love with Pres­i­dent Trump, for now

In the lead-up to the elec­tion, it was abun­dant­ly clear that most biotech ex­ecs — a well-ed­u­cat­ed group based large­ly in De­mo­c­ra­t­ic strong­holds — clear­ly sided with Hillary Clin­ton. Not that they were en­thu­si­as­tic about their deeply flawed can­di­date. If any­thing, the sen­ti­ment seemed clear­ly dri­ven by an­tipa­thy for Don­ald Trump.

Trump’s Know Noth­ing cam­paign aimed at ril­ing blue col­lar work­ers worked per­fect­ly, though, al­low­ing him to rip through the Rust Belt and eas­i­ly com­mand the elec­toral col­lege.

There are some im­me­di­ate ben­e­fits for bio­phar­ma that lie in a Trump win. If you look at it sole­ly through the prism of a bio­phar­ma in­vestor, the like­li­hood that Con­gress will low­er tax­es to en­able big cor­po­ra­tions to repa­tri­ate cash could make a ma­jor dif­fer­ence in the ac­tiv­i­ties of a Pfiz­er or Mer­ck. Adding the prospect of ad­van­ta­geous leg­is­la­tion aimed at fur­ther speed­ing an al­ready oiled ap­proval process may not be need­ed, but it can’t hurt in­vestors’ sen­ti­ment. And the pres­i­dent-elect’s si­lence on drug pric­ing has the hope­ful keep­ing their fin­gers crossed that we’ll hear no more ideas from Trump about drug reim­por­ta­tion or Medicare ne­go­ti­a­tions on whole­sale num­bers.

So the bio­phar­ma in­dus­try will take the quick gains and the prospect of a brighter fu­ture at the ex­pense of the big­ger so­cial loss­es like­ly from a Trump ad­min­is­tra­tion built on de­ri­sion and scorn. The in­dus­try is a fa­vored part­ner with the Re­pub­li­can pres­i­dent and a Re­pub­li­can-led Con­gress, even if there’s lit­tle love lost be­tween many of the top play­ers and the man about to take up res­i­dence at the White House.

Biotech ral­lies come and go, but some of these ear­ly im­pli­ca­tions and im­pres­sions will af­fect how the in­dus­try is shaped for the next four years.

Propo­si­tion 61 goes down in flames

Propo­si­tion 61 back­ers in Cal­i­for­nia had hoped that their ap­peal to cap drug prices at the rate the VA paid would ap­peal to vot­ers’ sense of fair play and the grow­ing anger over drug prices. In­stead, the “no” vote was backed by a well-fund­ed coun­ter­at­tack that hit on a bril­liant strat­e­gy: No phar­ma com­pa­ny, they told vot­ers, would give big dis­counts to vet­er­ans if that be­came a de fac­to price mod­el for dis­count­ing.

A vote for Propo­si­tion 61 be­came a vote against vet­er­ans. You may not agree with the theme, but you can’t de­ny the po­lit­i­cal savvy in­volved in set­ting up this seem­ing­ly sure thing for a hard fall in a blue state like Cal­i­for­nia.

So don’t ex­pect to see this tried any­where else. If Cal­i­for­nia re­jects Prop 61, so will most if not all oth­er states. And af­ter Tues­day’s vote, the is­sue is like­ly dead-on-ar­rival in any case.

We’re not sor­ry to see it go. Try­ing to find a back door on con­trol­ling drug prices is a non-starter. The pres­sure on drug prices, though, isn’t go­ing any­where.

The re­cent line­up of drug pric­ing scan­dals and Con­gres­sion­al hear­ings has made big an­nu­al price in­creas­es a big is­sue with the pub­lic. But there has to be a bet­ter way to han­dle the con­tro­ver­sy. Brent Saun­ders’ call for vol­un­tary price dis­ci­pline is one way. And com­mon sense ar­gu­ments to give Medicare the au­thor­i­ty to ne­go­ti­ate prices will stay on the front burn­er of Amer­i­can pol­i­tics.

What’s clear is that these re­cent votes has giv­en the in­dus­try a big say in how this de­bate will be shaped over the next 4 years. It’s im­por­tant not to squan­der that op­por­tu­ni­ty.

End­points News hits the #100 mark

A lit­tle more than four months in­to the game of dai­ly biotech news re­port­ing, we’re hap­py to take a mo­ment to do a few high fives about pub­lish­ing is­sue #100 of End­points News on elec­tion day. We’ve gath­ered more than 12,000 in­dus­try and in­vestor sub­scribers and added hun­dreds of thou­sands in web traf­fic read­ers since our launch. The fast-grow­ing read­er­ship po­si­tions us for a big an­niver­sary on June 20, 2017. As al­ways, we ap­pre­ci­ate our read­ers’ feed­back. We’re aim­ing at be­ing the on­ly dai­ly news feed on bio­phar­ma that you’ll need from here on out. With your help, that’s fast be­com­ing a re­al­i­ty.

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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Michel Vounatsos, Getty Images

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.