Pas­cal So­ri­ot is stay­ing at As­traZeneca af­ter all, con­firm­ing up­com­ing pre­sen­ta­tion - re­ports

As­traZeneca has stayed mum for two long days filled with an in­tense round of ru­mors and spec­u­la­tion over the fu­ture of their CEO, Pas­cal So­ri­ot. But the lat­est re­port out of Lon­don is that So­ri­ot has de­cid­ed to stay with the phar­ma gi­ant af­ter all, for­go­ing a re­port­ed of­fer of a $20 mil­lion bonus and a chance to re­or­ga­nize a trou­bled Te­va. And the com­pa­ny, while stay­ing silent on the sto­ry, is con­firm­ing plans for So­ri­ot to make a key pre­sen­ta­tion in about two weeks.

The lat­est news was bro­ken by Bloomberg Fri­day af­ter­noon but didn’t hit the In­ter­net im­me­di­ate­ly. StreetInsid­er cit­ed the re­port in a brief, say­ing that So­ri­ot “is cur­rent­ly plan­ning to stay for the fore­see­able fu­ture, ac­cord­ing to Bloomberg, cit­ing peo­ple with knowl­edge of the mat­ter.”

As­traZeneca in­vestors quick­ly bid up shares in the phar­ma gi­ant by more than 4% as news of the CEO’s plans to stay spread Fri­day, re­plac­ing the bil­lions lost ear­li­er as the mar­ket man­aged to over­come a bad case of nerves spurred by thoughts that an ex­it by So­ri­ot at this stage im­plied bad news for the cru­cial MYS­TIC study for dur­val­um­ab and treme­li­mum­ab. That Phase III da­ta is due any day now.

Of­fi­cial­ly, As­traZeneca is main­tain­ing the same po­si­tion it has held for the past two days. In re­sponse to a query of mine, a spokesper­son for As­traZeneca re­spond­ed: “Re­gard­ing the Te­va ru­mours still the same, we don’t com­ment on spec­u­la­tion.”

But the com­pa­ny did fol­low up with a time­ly note on an up­com­ing re­view of As­traZeneca’s H1 re­sults, for Ju­ly 27, close to two weeks from now, with a pre­sen­ta­tion by So­ri­ot. In­sid­ers are al­so telling the Fi­nan­cial Times that it’s busi­ness as usu­al at As­traZeneca.

There’s been plen­ty of time to chat­ter about all kinds of pos­si­bil­i­ties in the time since Cal­cal­ist first re­port­ed that So­ri­ot was in the fi­nal stages of ham­mer­ing out a con­tract. One of the lat­est dis­cus­sions cen­tered on the pos­si­bil­i­ty that Pfiz­er might make a re­newed bid if So­ri­ot was gone, leav­ing the door open to a deal that he spurned three years ago.

That ev­i­dent­ly won’t be hap­pen­ing, ei­ther.

Te­va Chair­man Sol Bar­er has made it clear that find­ing a cred­i­ble new CEO to lead the com­pa­ny at a time gener­ic pric­ing has erod­ed and its pipeline re­mains weak is a cru­cial task. Now he’ll be ex­pect­ed to go back and find some­one else to fill the po­si­tion — the fourth CEO in as many years. Te­va’s shares plunged 4% as the mar­ket clawed back gains from the last two days.

https://twit­ter.com/Arm­strong­Drew/sta­tus/885919752669057024

So­ri­ot is left in a dif­fi­cult spot, still work­ing on a turn­around as rev­enue slides in­to a trough and the pipeline proves far less ef­fec­tive than the CEO had promised.

One key are­na, on­col­o­gy, has de­liv­ered some sol­id gains with drugs like Lyn­parza and Tagris­so and pos­si­bly Imfinzi (dur­val­um­ab). But the big R&D cat­a­lyst this year cen­ters on As­traZeneca’s ques­tion­able MYS­TIC study, com­bin­ing dur­val­um­ab and treme­li­mum­ab, with plen­ty of deep seat­ed fears about the out­come. As­traZeneca had to set­tle for a fifth place fin­ish among the check­point con­tenders as it cen­tered its plans around So­ri­ot’s strat­e­gy of de­liv­er­ing com­bi­na­tions that could leapfrog the lead­ers in the field.

That strat­e­gy is far from be­ing ex­e­cut­ed on. And oth­er el­e­ments in the pipeline have been sore dis­ap­point­ments. As­traZeneca has ex­pe­ri­enced ma­jor set­backs on a score of big projects.

  • Bril­in­ta was sup­posed to be the un­pol­ished jew­el in As­traZeneca’s crown. It’s been a ma­jor dis­ap­point­ment.
  • Selume­tinib has been a flop, fail­ing back-to-back Phase III stud­ies.
  • There was a Phase III miss for tralok­inum­ab in asth­ma.
  • ZS-9 was kicked back by reg­u­la­tors twice for man­u­fac­tur­ing rea­sons, giv­ing a ri­val time to re­group and so­lid­i­fy its po­si­tion in the mar­ket.
  • The com­pa­ny has qui­et­ly and steadi­ly pulled out of an­tibi­otics.
  • A whole se­ries of drugs — in ad­di­tion to an­tibi­otics — have been sold off to sup­ply some fast rev­enue in place of what had been big peak sales fore­casts, among them bro­dalum­ab.

Most of that laun­dry list of set­backs was racked up in the last year.

All these prob­lem­at­ic drugs were in­tend­ed to play a big role in dou­bling As­traZeneca’s $23 bil­lion in 2016 rev­enue. Keep­ing that promise by 2023, which So­ri­ot used to win over in­vestors and re­ject Pfiz­er’s bid for the com­pa­ny in 2014, has been an in­creas­ing­ly un­like­ly prospect.

When So­ri­ot ar­rived at As­traZeneca, he made a great show of an­nounc­ing plans for a big new cam­pus in Cam­bridge, UK. Now that project, like so many things about As­traZeneca, is un­fin­ished, be­hind sched­ule and way over bud­get. He was sup­posed to have that done in 2016.

Now So­ri­ot will re­port­ed­ly be stay­ing for the fore­see­able fu­ture, to see if he can get this right.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Bris­tol-My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

David Meline, incoming Moderna CFO

Am­gen vet David Meline finds a new CFO roost at Mod­er­na, tak­ing a ride on the Covid-19 tiger as de­part­ing ex­ec cash­es out with $12M

We found out a few weeks ago that Moderna CFO Lorence Kim isn’t waiting around to see how the biotech wunderkind makes out in its frantic race to field a messenger RNA vaccine that can quell Covid-19. And now we know who’s stepping on board to take his place in the latest move in the executive suite.

David Meline, who forged his rep during a 6-year run at Amgen, slipped out the exit right after his Q2 “retirement” party in California — presumably virtual — and started the next chapter of his career at a biotech company betting big on revolutionizing the vaccine R&D space.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.