Don­ald Trump is start­ing to win over bio­phar­ma

It would ap­pear that Don­ald Trump is start­ing to win over the minds — though per­haps not the hearts — of the bio­phar­ma in­dus­try.

Af­ter we ran two ear­li­er polls re­flect­ing a deep dis­taste for the Re­pub­li­can, Trump’s up­set vic­to­ry fol­lowed by a surge in in­dus­try stocks was fol­lowed by a re­spectable show of sup­port in our lat­est poll of biotech and phar­ma­ceu­ti­cal in­dus­try read­ers.

With 165 votes in, close to half (46%) felt that bio­phar­ma would be bet­ter off un­der Trump a year from now. That com­pares to 28% who felt it will be worse and 26% who felt that it will be no dif­fer­ent on the an­niver­sary of his win.

 

“I re­spond­ed to an ear­li­er sur­vey you held by vot­ing that Hi­lary would be bet­ter for bio­phar­ma than Trump, but my rea­son­ing for that re­sponse was that Trump was just go­ing to be a thin-skinned dis­as­ter as a pres­i­dent and that he would get us in­to a war or ma­jor cri­sis that would hurt the econ­o­my se­vere­ly,” not­ed one read­er. “Look­ing at Trump more close­ly, I think he’ll be more of a pos­i­tive, at least short term.”

An­oth­er thumbs up, fol­lowed by a thumbs down: ”Less reg­u­la­tion and price con­trols. So, bet­ter be­cause the in­dus­try will make more mon­ey and more re­search & ad­vance­ments will hap­pen. Worse, be­cause when a few bad ac­tors take ad­van­tage of this, there will be even big­ger rep­u­ta­tion hits for the in­dus­try. Think Shkre­li with a big­ger biotech.”

And don’t un­der­es­ti­mate the un­der­ly­ing dis­taste many of our read­ers have for Trump.

Vot­ing worse, a read­er notes: “The stock mar­ket will go down once he’s in of­fice. We will be in a pe­ri­od of in­sta­bil­i­ty. If his tax cuts go for­ward we will have an­oth­er re­ces­sion which will im­pact the abil­i­ty to raise mon­ey.”

One rea­son for the change of pos­i­tive sen­ti­ment can be seen in vot­ers thoughts on the like­ly shift ahead in M&A. A clear ma­jor­i­ty of re­spon­ders felt that Trump’s eco­nom­ic and tax poli­cies would help spur greater M&A in the in­dus­try, which can help over­all stock val­ues.

Here are some com­ments fa­vor­ing in­creased M&A, in which a num­ber of read­ers high­light­ed the like­li­hood of tax re­form:

“Par­tic­u­lar­ly if the tax code changes to en­cour­age com­pa­nies with cash trapped out­side the US to bring it back.”

“I as­sume he will ne­go­ti­ate a fa­vor­able phar­ma/biotech repa­tri­a­tion pol­i­cy (hel­lo Re­pub­li­can con­gress and sen­ate!) for ex-US dol­lars which will fu­el M&A.”

Here’s a note of cau­tion:

“We don’t quite know what are his eco­nom­ic poli­cies.”

The pres­i­dent-elect has clear­ly in­di­cat­ed that he wants to speed up the FDA and new drug ap­provals, but most read­ers aren’t ex­pect­ing any kind of dra­mat­ic change soon. Two-thirds said they don’t ex­pect a change in the next year. But 28% did be­lieve the FDA will be prod­ded in­to act­ing more quick­ly.

The same pro­por­tion of peo­ple be­lieve that the stock ral­ly will in­evitably flat­ten out, with the same num­ber look­ing for a con­tin­u­ing bull mar­ket.

“There will be lots of rhetoric but over­all no change, es­pe­cial­ly if the com­mis­sion­er stays in place.”

“I ex­pect some type of re­form, and some di­vi­sions sure need to speed up, but oth­ers (on­col­o­gy) al­ready are mov­ing at warp speed.”

“Sub­ject to the se­lec­tion of a trans­for­ma­tion­al leader whom I can­not iden­ti­fy, the agency will chug along al­most with­out re­gard to ad­min­is­tra­tion change. Four years is ac­tu­al­ly a pret­ty short time in FDA terms. Once the pub­lic learns that even “The Don­ald” can’t de­liv­er (no Wall, no pmt from Mex­i­co, lit­tle re­form, few jobs), he may be turfed out with the same en­thu­si­asm with which he was elect­ed. “

Fi­nal­ly, a sig­nif­i­cant mi­nor­i­ty of 43% said they ex­pect for­eign-born sci­en­tists will start leav­ing the US af­ter Trump takes of­fice. Slight­ly more than half said they ex­pect things will stay the same on that score. And you could hear a com­mon theme among many of the com­ments we re­ceived. Trump, many be­lieve, can’t be as bad as he made him­self out to be.

“As long as Trump is not a com­plete id­iot – I sus­pect he does not re­al­ly in­tend to do a lot of the things he said dur­ing the cam­paign.”

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 $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday 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 on his plans to surgically dissect and reassemble the portfoloio, 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.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Chris Garabedian. Xontogeny

Per­cep­tive teams up with Chris Garabe­di­an to open up a new, $210M biotech fund fo­cused on A rounds

Perceptive Advisors is one of those prolific biotech investor groups which has traditionally enjoyed zeroing in on clinical-stage investments and crossover rounds, a group that prefers more established drug development players with near-term payoff potential.

But now they’re partnering with Xontogeny chief and longtime biotech entrepreneur Chris Garabedian on a $210 million fund — with money contributed by institutional investors and family funds — to go into the launch space with their first early-stage VC fund. Dubbed the Perceptive Xontogeny Venture Fund, LP, or just PXV Fund, they plan to favor upstarts that Garabedian is fostering in his incubator. But they’ll also plan to reach outside that inner circle for more A rounds to back, with plans to dominate initial funding with $10 million to $20 million per newborn biotech.

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.”

This is the second biotech buyout pact today, marking a brisk tempo of M&A deals in the lead-up to the big JP Morgan gathering in mid-January. It’s no surprise the acquisitions are both for cancer drugs, where Sanofi will try to make its mark while Merck beefs up a stellar oncology franchise. And bolt-ons are all the rage at the major pharma players, which you could also see in Novartis’ recent $9.7 billion MedCo buyout.

ArQule — which comes out on top after their original lead drug foundered in Phase III — highlighted early data on ‘531 at EHA from a group of 6 chronic lymphocytic leukemia patients who got the 65 mg dose. Four of them experienced a partial response — a big advance for a company that failed with earlier attempts.

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US biosim­i­lar launch­es about to turn a cor­ner

The US biosimilar industry has lingered in the shadow of the European market since the US pathway for approvals was initiated in 2009.

Ten years later (or less than five years since the first FDA approval of a biosimilar), and just 42% (11 out of 26) of FDA-approved biosimilars have launched. But in the next three months (see chart below), a clutch of new biosimilars will hit the market, including new ones in oncology, hinting at a wave of uptake.

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.