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.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus -- chop­ping di­a­betes, car­dio and slash­ing costs in com­pa­ny-wide re­org

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy reveal tomorrow with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

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Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

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KalVis­ta's di­a­bet­ic mac­u­lar ede­ma da­ta falls short — will Mer­ck walk away?

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.