Te­va gets a mixed bag of PhI­II da­ta as it lines up against a (bet­ter?) Neu­ro­crine ri­val for tar­dive dysk­i­ne­sia

Four months af­ter the FDA re­ject­ed Te­va’s “break­through” drug SD-809 for treat­ing chorea as­so­ci­at­ed Hunt­ing­ton’s dis­ease, the phar­ma group is back with a batch of mixed Phase III da­ta on tar­dive dysk­i­ne­sia, the in­vol­un­tary move­ments as­so­ci­at­ed with the de­gen­er­a­tive dis­ease. And once again Te­va is up­beat about the re­sults, say­ing the da­ta clears the way to a new mar­ket­ing pitch lat­er this year.

A year-and-a-half ago Te­va $TE­VA splurged on a $3.5 bil­lion ac­qui­si­tion of Aus­pex, bag­ging the new and what it hoped was an im­proved drug for Hunt­ing­ton’s. Now it’s say­ing that its sec­ond late-stage study shows that the drug is clear­ly a suc­cess, but there are still some sig­nif­i­cant prob­lems to ad­dress.

In­ves­ti­ga­tors say that a high and mid-range dose of their drug hit the pri­ma­ry end­point on the move­ment scale rat­ing for a “mod­i­fied in­tent to treat” group. The low dose failed to sep­a­rate sig­nif­i­cant­ly from the place­bo. But the high dose, mean­while, missed beat­ing the place­bo based on in­ves­ti­ga­tors’ as­sess­ment of how their pa­tients were do­ing.

Te­va’s big pro­gram for this drug puts it in a head-to-head show­down with Neu­ro­crine $NBIX, which not­ed just days ago that it has filed for an ap­proval on the ri­val drug val­be­nazine.

Neu­ro­crine ex­ecs not­ed in their Q2 call with an­a­lysts at the end of Au­gust that they are al­ready build­ing a mar­ket­ing group for the drug, which has al­so achieved a break­through drug des­ig­na­tion that could put it on track to an ap­proval as ear­ly as next spring. The drug is a VMAT2 in­hibitor, de­signed to mod­u­late dopamine re­lease dur­ing nerve com­mu­ni­ca­tion.

Baird’s Bri­an Sko­r­ney com­pared the two drugs, and vot­ed on Neu­ro­crine as the like­ly win­ner in this loom­ing show­down. Val­be­nazine did bet­ter at beat­ing a place­bo, with a 3.1 re­duc­tion com­pared to place­bo ver­sus a 1.9 dif­fer­ence in fa­vor of Te­va’s drug.

Added Sko­r­ney:

With at least a few months’ lead time and po­ten­tial un­cer­tain­ty around the meta­bol­ic pro­file of SD-809, we re­main con­fi­dent that val­be­nazine, now brand­ed as In­grez­za, can gar­ner stronger sup­port from physi­cians at launch.

Jef­feries’ Biren Amin agreed with Sko­r­ney on the time­line, putting Neu­ro­crine in the lead by sev­er­al months.

Te­va’s drug rep­re­sents a big bet for the Is­raeli com­pa­ny, which was hop­ing to be in the first wave of com­pa­nies to get an ap­proval for a deuter­at­ed drug, tak­ing an ex­ist­ing drug — in this case tetra­benazine (Xe­nazine) — and re­design­ing it to break down more slow­ly, a tweak which should make it pos­si­ble to pro­vide low­er dos­ing for max­i­mum ef­fect while im­prov­ing the safe­ty pro­file.

The FDA hasn’t re­quired a head-to-head study against tetra­benazine, which may come back to haunt Te­va if it does get a mar­ket­ing ap­proval. But it has asked for more work ex­am­in­ing the lev­els of metabo­lites in­volved in break­ing down the drug.

The ther­a­py—deutetra­benazine—is a small mol­e­cule in­hibitor of vesic­u­lar monoamine 2 trans­porter, or VMAT2, which is de­signed to reg­u­late the lev­els of dopamine in the brain.

A re­cent sto­ry in Bloomberg high­light­ed an­a­lysts’ pro­jec­tions of about a bil­lion dol­lars a year in an­nu­al rev­enue, if Te­va can make its case to pa­tients put off by the side ef­fects of the orig­i­nal drug, which in­clude de­pres­sion. More re­search work is be­ing done on Tourette syn­drome.

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
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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Paul Hudson, Sanofi

Paul Hud­son promis­es a bright new fu­ture at Sanofi, kick­ing loose me-too drugs and fo­cus­ing on land­mark ad­vances. But can he de­liv­er?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class.  The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

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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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Am­gen puts its foot down in shiny new South San Fran­cis­co hub as it re­or­ga­nizes R&D ops

Amgen has signed up to be AbbVie’s neighbor in South San Francisco as it moves into a nine-story R&D facility in the booming biotech hub.

The arrangement gives Amgen 240,000 square feet of space on the Gateway of Pacific Campus, just a few minutes drive from its current digs at Oyster Point. The new hub will open in 2022 and house the big biotech’s Bay Area employees working on cardiometabolic, inflammation and oncology research.

Ab­b­Vie, Scripps ex­pand part­ner­ship, for­ti­fy fo­cus on can­cer drugs

Scripps and AbbVie go way back. Research conducted in the lab of Scripps scientist Richard Lerner led to the discovery of Humira. The antibody, approved by the FDA in 2002 and sold by AbbVie, went on to become the world’s bestselling treatment. In 2018, the drugmaker and the non-profit organization signed a pact focused on developing cancer treatments — and now, the scope of that partnership has broadened to encompass a range of diseases, including immunological and neurological conditions.

South Ko­rea jails 3 Sam­sung ex­ecs for de­stroy­ing ev­i­dence in Bi­o­Log­ics probe

Three Samsung executives in Korea are going to jail.

The convictions came in what prosecutors had billed as “biggest crime of evidence destruction in the history of South Korea”: a case of alleged corporate intrigue that was thrown open when investigators found what was hidden beneath the floor of a Samsung BioLogics plant. Eight employees in total were found guilty of evidence tampering and the three executives were each sentenced to up to two years in prison.

Nick Plugis, Avak Kahvejian, Cristina Rondinone, Milind Kamkolkar and Chad Nusbaum. (Cellarity)

Cel­lar­i­ty, Flag­ship's $50M bet on net­work bi­ol­o­gy, mar­ries ma­chine learn­ing and sin­gle-cell tech for drug dis­cov­ery

Cellarity started with a simple — but far from easy — idea that Avak Kahvejian and his team were floating around at Flagship Pioneering: to digitally encode a cell.

As he and his senior associate Nick Plugis dug deeper into the concept, they found that most of the models others have developed take a bottom-up approach, where they assemble the molecules inside cells and the connections between them from scratch. What if they opt for a top-down approach, aided by single-cell transcriptomics and machine learning, to gauge the behavior of the entire cellular network?

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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