To tack­le su­per­bug scourge and re­vive R&D, in­cen­tivize FDA an­tibi­ot­ic ap­provals — drug­mak­ers, health groups urge US law­mak­ers

As su­per­bugs flour­ish, the in­dus­try play­ers con­tribut­ing to the ar­se­nal of an­timi­cro­bials are dwin­dling. Drug­mak­ers are en­ticed by green­er pas­tures, com­pared to the long ar­du­ous path to an­tibi­ot­ic ap­proval that of­fers lit­tle fi­nan­cial gain as treat­ments must be priced cheap­ly, and of­ten lose po­ten­cy over time as mi­crobes grow re­sis­tant to them. For one of the biggest threats to glob­al health, the li­on’s share of an­tibi­ot­ic de­vel­op­ment is tak­ing place in a hand­ful of labs of small bio­phar­ma com­pa­nies as their larg­er coun­ter­parts fo­cus on more lu­cra­tive en­deav­ors. Ex­ist­ing in­cen­tives to en­tice an­tibi­ot­ic R&D are too fee­ble to fix this bro­ken sys­tem, a group of drug­mak­ers, pub­lic health or­ga­ni­za­tions and doc­tors said in a let­ter to US law­mak­ers on Tues­day, urg­ing Sen­a­tors to take a fresh ap­proach to stim­u­late an­timi­cro­bial drug de­vel­op­ment by en­act­ing pol­i­cy mea­sures to in­crease the val­ue of a mar­ket­ed an­tibi­ot­ic.

Be­yond the in­cen­tives al­ready in place to push drug­mak­ers to de­vel­op an­tibi­otics, the group urged the pas­sage of “pull in­cen­tives,” or pol­i­cy mea­sures to in­crease the val­ue of a mar­ket­ed an­tibi­ot­ic by re­ward­ing drug­mak­ers on­ly af­ter their an­tibi­ot­ic is ap­proved by the FDA.

The group rep­re­sent­ed in the let­ter in­clude both big drug­mak­ers (GSK, Mer­ck, Pfiz­er) and small (Achao­gen, Melin­ta, Paratek, Tetraphase) as well as or­ga­ni­za­tions such as the An­timi­cro­bial In­no­va­tion Al­liance An­timi­cro­bials Work­ing Group, In­fec­tious Dis­eases So­ci­ety of Amer­i­ca and The Pew Char­i­ta­ble Trusts.

Oth­er law­mak­ers have voiced sim­i­lar con­cerns and pro­posed al­ter­na­tive ways to rein­vig­o­rate an­tibi­ot­ic R&D. Last month, a UK gov­ern­ment re­port out­lined a plan to de-cou­ple price from de­mand and shift to a more val­ue-based ap­proach that would com­pel in­sti­tu­tions to pay fees based on their need for new an­tibi­otics, akin to a li­cens­ing ap­proach that FDA com­mis­sion­er Scott Got­tlieb sug­gest­ed in re­cent months.

“(The) fu­ture of an­tibi­ot­ic de­vel­op­ment is grim…Few ma­jor phar­ma­ceu­ti­cal com­pa­nies re­main en­gaged in an­tibi­ot­ic dis­cov­ery and de­vel­op­ment, and small biotech firms, even those that have launched or are close to launch­ing prod­ucts, strug­gle to sus­tain a vi­able com­mer­cial en­ter­prise,” the group wrote, not­ing that of the cur­rent drugs in de­vel­op­ment, on­ly 11 have the po­ten­tial to ad­dress the most crit­i­cal Gram-neg­a­tive pathogens on the WHO’s pri­or­i­ty list of an­tibi­ot­ic-re­sis­tant mi­crobes.

Mean­while, there are over 1,000 can­cer drugs in de­vel­op­ment.

Each year in the Unit­ed States at least 2 mil­lion peo­ple con­tract an an­tibi­ot­ic-re­sis­tant in­fec­tion, and at least 23,000 peo­ple die, ac­cord­ing to the CDC.

The mass ex­o­dus of large play­ers, in­clud­ing Al­ler­gan, Sanofi and As­traZeneca is now im­pact­ing small­er drug­mak­ers. His­tor­i­cal­ly, small com­pa­nies would shep­herd an­tibi­otics through the ear­ly stages of de­vel­op­ment, and then seek a part­ner with deep pock­ets to help cross the fin­ish line — but with a pauci­ty of Big Phar­ma in the field, small­er play­ers are strug­gling, they wrote.

Achao­gen and Melin­ta, col­lec­tive­ly re­spon­si­ble for five re­cent­ly-mar­ket­ed an­tibi­otics, have both an­nounced the clos­ing of their an­tibi­ot­ic re­search and clin­i­cal de­vel­op­ment pro­grams. Sev­er­al oth­er small com­pa­nies with re­cent­ly ap­proved prod­ucts are in jeop­ardy of shut­ter­ing their op­er­a­tions en­tire­ly in 2019. Many of these com­pa­nies re­ceived sig­nif­i­cant fund­ing to sup­port their R&D pro­grams from U.S. Gov­ern­ment fun­ders…If they fail, it is like­ly to prompt the de­par­ture of what lit­tle pri­vate in­vest­ment re­mains in the an­timi­cro­bial space, with dis­as­trous con­se­quences for the al­ready in­ad­e­quate pipeline.

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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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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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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Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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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. File photo

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.

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