As­traZeneca’s PhI­II bid on asth­ma drug tralok­inum­ab flops, and that’s no sur­prise

Maybe the best way to look at As­traZeneca R&D now is by di­vid­ing the re­search group in­to two big buck­ets: can­cer and every­thing else. That “every­thing else” group was just hit with a wide­ly ex­pect­ed Phase III fail­ure that the drug gi­ant can ill af­ford as it strug­gles to make a con­vinc­ing case for a des­per­ate­ly need­ed turn­around.

Sean Bo­hen, As­traZeneca

This time the late-stage fail­ure be­longs, once again, to its IL-13 asth­ma drug tralok­inum­ab. In its first of two Phase III stud­ies, the drug failed to sig­nif­i­cant­ly re­duce an­nu­al ex­ac­er­ba­tion rates. There is a sec­ond Phase III un­der­way that As­traZeneca be­lieves could hold the key to ul­ti­mate suc­cess, say­ing that they will com­bine da­ta from the two in de­ter­min­ing its fu­ture.

In ad­di­tion, re­searchers point­ed to a sub-pop­u­la­tion analy­sis in which pa­tients with an el­e­vat­ed mark­er for IL-13 re­spond­ed bet­ter to the drug and they plan to make that a spe­cial fo­cus of the sec­ond tri­al.

How­ev­er.

This drug al­ready failed a Phase IIb tri­al for asth­ma, rais­ing ques­tions about why the com­pa­ny would go ahead and con­tin­ue a ma­jor late-stage ef­fort need­ed to get an OK in asth­ma. But the re­searchers at the time said they were en­cour­aged by a sub­group analy­sis that point­ed to suc­cess. The com­pa­ny qui­et­ly dumped the id­io­path­ic pul­monary fi­bro­sis pro­gram, but in­sist­ed that there was every rea­son to be­lieve that tralok­inum­ab would work in asth­ma. On top of that, Roche’s drug le­brik­izum­ab, al­so an IL-13, came up with a split de­ci­sion in its two Phase III stud­ies last year that amount­ed to a se­vere set­back on that front.

As­traZeneca post­ed some mixed — though gen­er­al­ly pos­i­tive — da­ta from two big Phase III stud­ies of ben­ral­izum­ab, its IL-5 con­tender in the high­ly com­pet­i­tive mar­ket for se­vere asth­ma, last fall. A high place­bo re­sponse se­ri­ous­ly erod­ed one set of late-stage da­ta.

The phar­ma gi­ant sold off the der­ma­tol­ogy rights for tralok­inum­ab to Leo Phar­ma, which says it gath­ered pos­i­tive IPF da­ta on the drug re­cent­ly. As­traZeneca al­so punt­ed rights to bro­dalum­ab af­ter that drug proved dis­ap­point­ing, though ap­prov­able, in Phase III with ev­i­dence that it trig­gered sui­ci­dal think­ing.

As­traZeneca’s stock was large­ly un­af­fect­ed by the Phase III fail­ure to­day, which couldn’t have sur­prised many an­a­lysts. The big play at As­traZeneca now is fo­cused on MYS­TIC, its com­bi­na­tion study of dur­val­um­ab and treme­li­mum­ab in lung can­cer. As­traZeneca has had some big suc­cess­es in can­cer over the last cou­ple of years, win­ning a first OK for dur­val­um­ab and pro­gress­ing with oth­er drugs like Tagris­so and Lyn­parza. But out­side can­cer the com­pa­ny has had a se­ries of grim flops that con­tin­ue to raise ques­tions about CEO Pas­cal So­ri­ot’s promise of a turn­around.

Re­search chief Sean Bo­hen had this to say in the com­pa­ny’s de­fense to­day:

Se­vere asth­ma is a het­ero­ge­neous dis­ease with sig­nif­i­cant un­met needs and we will now await the STRATOS 2 re­sults in the sec­ond half of 2017 to ex­plore the po­ten­tial to treat a sub-group of un­con­trolled asth­ma pa­tients with tralok­inum­ab.

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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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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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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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.